Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Efficacy of CBT-I With Adjuvant Melatonin in Older Adults Chronic Insomnia (SOAM)

5. Juli 2026 aktualisiert von: Dr. Shirley Xin Li, The University of Hong Kong

Efficacy of Cognitive Behavioural Therapy for Insomnia With Adjuvant Melatonin Treatment in Older Adults With Chronic Insomnia: A Randomised Controlled Trial

This study tests the efficacy of cognitive behavioural therapy for insomnia (CBT-I) with or without adjunct melatonin in older adults with insomnia. Adults aged 60 or above with chronic insomnia will be randomly assigned to one of three groups: (1) CBT-I plus nightly melatonin, (2) CBT-I plus nightly placebo tablet, or (3) sleep health psychoeducation plus nightly placebo tablet. All group sessions occur weekly for four weeks.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

This randomized, double-blind, placebo-controlled trial examines whether cognitive behavioural therapy for insomnia (CBT-I) with or without adjunct melatonin improves sleep and circadian outcomes as well as daytime functioning in older adults with chronic insomnia.

Eligible participants (aged ≥60 years, meeting DSM-5 criteria for insomnia disorder) will be recruited and randomly assigned to one of the three parallel groups: (1) CBT-I combined with nightly melatonin, (2) CBT-I with nightly placebo, or (3) sleep-health psychoeducation with nightly placebo. All interventions involve four weekly 90-minute group sessions (6-8 participants per group) conducted in person. Melatonin (3 mg immediate-release) or a matched placebo will be taken 30 minutes before habitual bedtime for four weeks.

Assessments will be conducted at baseline, mid-treatment (week 2, for the primary outcome only), and post-treatment (week 4) for all participants, and additionally at three-month and six-month follow-ups for participants in the two CBT-I groups. Data collection includes validated questionnaires on sleep, circadian, mood, fatigue, and quality of life, as well as computerized cognitive tasks to assess domains such as attention, working memory, and executive function. Objective sleep and circadian parameters will be measured by actigraphy for seven consecutive nights, along with a daily sleep diary. Participants will also complete polysomnography (PSG) for objective sleep assessment. To index circadian timing, a subset of participants will collect saliva samples (about 1 mL each) every 30 minutes under dim-light conditions in the evening to estimate dim-light melatonin onset (DLMO).

The primary outcome is the change in self-reported insomnia severity from baseline to post-treatment. Secondary outcomes include resumption and treatment response of insomnia, clinical symptom severity, objective and subjective sleep- and circadian-related outcomes, mood, daytime functioning, quality of life, and cognitive performance.

The study is conducted across two sites - The University of Hong Kong (Department of Psychology) and The Chinese University of Hong Kong (Department of Psychiatry). Findings are expected to clarify whether melatonin can augment the efficacy and sustainability of CBT-I in older adults, providing new insights into circadian-based strategies for improving sleep health in late life.

Studientyp

Interventionell

Einschreibung (Geschätzt)

183

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Shirley Xin LI, DClinPsy, PhD
  • Telefonnummer: 852 39177035
  • E-Mail: shirleyx@hku.hk

Studieren Sie die Kontaktsicherung

Studienorte

  • Hongkong
      • Hong Kong, Hongkong
        • Sleep Research Clinic and Laboratory, Department of Psychology, The University of Hong Kong
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  1. Chinese aged ≥ 60.
  2. Provision of written informed consent.
  3. Having a DSM-5 diagnosis of insomnia disorder (i.e., having difficulty initiating sleep, maintaining sleep, or early morning awakening at least three times a week for at least three months, with clinically significant impairment or distress).
  4. Having a score of > 14 on the ISI, indicating clinical insomnia.

Exclusion Criteria:

  1. Having a current diagnosis or a history of manic or hypomanic episodes, schizophrenia spectrum disorders, neurodevelopmental disorders, neurocognitive disorders, organic mental disorders, intellectual disabilities, or substance abuse or dependence.
  2. Having a progressive medical condition directly related to the onset and course of insomnia (e.g., cancer, chronic pain).
  3. Undergoing treatment for diseases known to affect sleep (e.g., chemotherapy).
  4. Having an untreated sleep disorder that may disrupt sleep continuity and quality (e.g., sleep-disordered breathing) except for insomnia disorder and circadian sleep-wake phase disorder.
  5. Having mild to significant cognitive impairment, defined by having a score of < 22 on MOCA.
  6. Concurrent and regular use of extraneous melatonin or melatonin agonist (e.g., ramelteon).
  7. Receiving concurrent psychological treatment for insomnia.
  8. Meeting potential contraindications for melatonin (e.g., undergoing dialysis) or concurrently using medications that have a potential drug interaction with melatonin (e.g., anticoagulant and anti-platelet).
  9. Being a night shift worker.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: CBT-I + Melatonin
Four weekly group-based CBT-I sessions (120-min, 6-8 participants) plus oral melatonin 3 mg immediate-release taken 30 min before habitual bedtime for 4 weeks.
Verhalten: Cognitive behavioural therapy for insomnia

CBT-I is a multi-component, non-pharmacologic intervention that targets behavioural, cognitive, and physiological perpetuating factors of insomnia.

Four group-based weekly sessions (120-min; 6-8 participants) will be delivered. Components: sleep psychoeducation, sleep hygiene, stimulus control, sleep restriction, relaxation training, cognitive restructuring (addressing dysfunctional beliefs about sleep), and relapse prevention. Delivered in-person by trained therapists supervised weekly by the PI.

Nahrungsergänzungsmittel: Melatonin 3 mg immediate-release
Melatonin is a safe and accessible sleep-promoting supplement. The tablet will be taken once daily, 30 minutes before habitual bedtime for 4 weeks, concurrent with CBT-I.
Aktiver Komparator: CBT-I + Placebo
Identical four weekly group-based CBT-I sessions plus placebo capsule (identical appearance) taken 30 min before habitual bedtime for 4 weeks.
Verhalten: Cognitive behavioural therapy for insomnia

CBT-I is a multi-component, non-pharmacologic intervention that targets behavioural, cognitive, and physiological perpetuating factors of insomnia.

Four group-based weekly sessions (120-min; 6-8 participants) will be delivered. Components: sleep psychoeducation, sleep hygiene, stimulus control, sleep restriction, relaxation training, cognitive restructuring (addressing dysfunctional beliefs about sleep), and relapse prevention. Delivered in-person by trained therapists supervised weekly by the PI.

Arzneimittel: Placebo Oral Tablet
Placebo capsule identical in appearance to the melatonin capsule, taken once daily, 30 minutes before habitual bedtime for 4 weeks. Used in CBT-I + Placebo and Psychoeducation + Placebo arms.
Placebo-Komparator: Psychoeducation + Placebo
Four weekly group-based sleep psychoeducation sessions (sleep hygiene, healthy diet, and exercise for older adults; no active CBT-I components) plus placebo capsule for 4 weeks.
Arzneimittel: Placebo Oral Tablet
Placebo capsule identical in appearance to the melatonin capsule, taken once daily, 30 minutes before habitual bedtime for 4 weeks. Used in CBT-I + Placebo and Psychoeducation + Placebo arms.
Verhalten: Psychoeducation
Four group-based weekly sessions covering sleep hygiene, healthy diet, and exercise habits for older adults. This arm will not include any active therapeutic CBT-I components. It serves as the active control, controlling for attention and non-specific expectancy effects.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Insomnia Symptoms - Insomnia Severity Index
Zeitfenster: Baseline, Mid-session (Week 2 of the intervention), Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Insomnia symptoms measured by Insomnia Severity Index (ISI). ISI is a 5-item self-rated scale. Possible scores range from 0 to 20, with higher scores indicating greater insomnia severity.
Baseline, Mid-session (Week 2 of the intervention), Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Treatment Response of Insomnia
Zeitfenster: Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Defined as a decrease of ≥ 8 points on the ISI (self-reported)
Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Remission of insomnia
Zeitfenster: Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Insomnia remission is defined as an ISI score less than 8. The outcome will be reported as the number and percentage of participants meeting remission criteria.
Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Self Report Sleep Quality - The Pittsburgh Sleep Quality Index
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Pittsburgh Sleep Quality Index (PSQI) is a self-rated scale consisting of 19 questions. All items are combined to form seven component scores on different aspects of sleep quality, each of which ranges from 0 to 3 points with higher scores representing more sleep disturbance. The seven component scores are added to one global score, which ranges from 0 to 21, with higher scores indicating more difficulties with sleep.
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Self-Report Chronotype Measures The Munich Chronotype Questionnaire
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
The Munich Chronotype Questionnaire (MCTQ) is a self-report measures of sleeping patterns during weekdays and weekends separately. The Mid-Sleep Time (MSF/MSFsc) are used to as an indicator of chronotype, where individuals with earlier mid-sleep time reflect a morning chronotype and later mid-sleep time reflect an evening chronotype.
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Self-Report Chronotype Preference: The Morningness-Eveningness Questionnaire
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
The Morningness-Eveningness Questionnaire (MEQ) is a 19-item self-assessment tool used to determine an individual's chronotype with a total score between 16 and 86. A higher score indicates a morning chronotype (e.g., "morning type"), a lower score indicates an evening chronotype (e.g., "evening type"), and a mid-range score indicates an intermediate chronotype.
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Self-report Mood Symptoms - Hospital Anxiety and Depression Scale
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Hospital Anxiety and Depression Scale (HADS), a 14-item self-report questionnaire used to screen for anxiety and depression in a patient's recent past week. The depression subscale ranges in scores from 0 to 21, with higher scores indicating more severe states of depression. Similarly, the anxiety subscale ranges in scores from 0-21 with higher scores indicating more severe states of anxiety.
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Self-report Daytime Sleepiness - Epworth Sleepiness Scale
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Epworth sleepiness scale, a short self-assessment to identify how likely you are to fall asleep during the daytime. Scores range from 0 to 24, a higher score indicates a higher level of excessive daytime sleepiness.
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Self-report Daytime Fatigue - Multidimensional Fatigue Inventory
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Multidimensional Fatigue Inventory (MFI) is a 20-item self-rated scale on fatigue symptoms. There are three subscales, measuring the physical (possibly scored from 7 to 35), mental (possibly scored from 6 to 30), and spiritual (possibly scored from 7 to 35), dimensions of fatigue. A grand total score can be calculated by summing up the three sub scores. In all cases, a higher score represents higher fatigue symptoms.
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Overall Severity of Clinical Symptoms
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Clinical Global Impression (CGI) Scale is a clinician-rated scale, comprised of two one-item subscales: Severity of Illness (CGI-S) subscale evaluating the severity of psychopathology, and Clinical Global Improvement Scale (CGI-I) evaluating change from the initiation of treatment. In both cases, the score is given on a seven-point scale, with higher values indicating higher severity of illness and larger improvement, respectively. CGI-S will be used to evaluate the overall severity of clinical symptoms.
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Overall Treatment Response
Zeitfenster: Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Clinical Global Impression (CGI) Scale is a clinician-rated scale, comprised of two one-item subscales: Severity of Illness (CGI-S) subscale evaluating the severity of psychopathology, and Clinical Global Improvement Scale (CGI-I) evaluating change from the initiation of treatment. In both cases, the score is given on a seven-point scale, with higher values indicating higher severity of illness and larger improvement respectively. Overall treatment response is defined as CGI-I <3 (clinician-rated)
Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Self Report Quality of Life - 36-Item Short Form Health Survey
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
The SF-36, or Short Form 36 Health Survey, is a 36-item patient-reported questionnaire that measures health status and quality of life. It assesses eight different health domains, including physical functioning, bodily pain, vitality, general health, role-physical, role-emotional, social functioning, and mental health. Total scores range from 0 to 100, where higher scores indicate better health.
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Objective Cognitive Performance (attention/inhibitory ability)
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
The stop-signal task is a behavioural task that measures a person's ability to inhibit a pre-programmed response. The main measure of inhibitory control is the stop-signal reaction time (SSRT), which estimates the time it takes to cancel a response. A longer SSRT indicates a slower ability to inhibit a response.
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Objective Cognitive Performance (Alertness)
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Psychomotor Vigilance Task (PVT) is a reaction-time test that measures sustained attention by having a person respond as quickly as possible to a visual stimulus that appears at random intervals. Reaction Time (RT): The primary measurement is how quickly the participant responds to the stimulus. Lapses: A lapse is a failure to respond to the stimulus within a certain time frame, often defined as a reaction time longer than 500 milliseconds.
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Objective Cognitive Performance (working memory by N-Back)
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
N-back Task for assessing working memory capacity and manipulation. In N-back Task, a d prime score will be calculated based on the signal detection theory, where a higher score indicates better working memory performance.
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Objective Cognitive Performance (problem solving)
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Wisconsin Card Sorting Test for assessing problem solving. In Wisconsin Card Sorting Test, lower executive functioning is indicated by a higher percentage of persistent errors and a higher number of trials taken to complete the first category.
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Objective Cognitive Performance (episodic memory)
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Chinese Auditory Verbal Learning Task for assessing episodic memory, where a higher number of recalled words indicates better episodic memory performance.
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Self-report Cognition - Multifactorial Memory Questionnaire
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Multifactorial Memory Questionnaire (MMQ) is a 57-item self-report assessing memory satisfaction, ability and strategy use (three subscales).For each subscale, score ranges: for each subscale: Satisfaction (0-72), Ability (0-80), and Strategy (0-76). A higher score generally indicates better self-reported memory functioning, higher satisfaction with memory, and greater use of memory strategie
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Self-report Depressive Symptoms - Beck Depression Inventory-II
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Beck Depression Inventory-II (BDI-II) is 21-item self-report of depressive-symptom severity during the past two weeks (0-63). Higher scores indicate more severe depressive symptoms
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Clinician Rated Depressive Symptoms - The Hamilton Rating Scale for Depression
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
The Hamilton Rating Scale for Depression (HAM-D17) is a 17-item interview to assess the severity of depression symptoms. Scores are interpreted based on a range: 0-7 indicates no depression, 8-16 is mild, 17-23 is moderate, and 24 or higher is severe depression.
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Self Report: Dysfunctional sleep beliefs
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS): 16 statements evaluating maladaptive sleep-related cognitions (0-160). A higher score indicates a higher level of dysfunctional, unhelpful, or rigid beliefs about sleep.
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Self-report Cognitive Functioning: Cognitive Failures Questionnaire Score
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Cognitive Failures Questionnaire; 25 items indexing self-reported failures in attention, memory and action execution, 0-100. Indicates a higher frequency of everyday cognitive failures.
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Self Report: Pre-sleep somatic arousal
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Pre-Sleep Arousal Scale (PSAS): 16 items measuring somatic and cognitive arousal at bedtime (8 each; 1-5 Likert, total score range 8-40). Higher scores indicate greater pre-sleep physical distress.
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Self Report: Stress-related insomnia vulnerability
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Ford Insomnia Response to Stress Test (FIRST): 9-item trait measure of likelihood that stress will provoke insomnia (0-36).
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Self Report: Sleep Hygiene Practices Scale (SHPS)
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Sleep Hygiene Practices Scale (SHPS): 30 items assessing frequency of behaviours affecting sleep quality (0-120). Higher scores indicate more maladaptive (unhealthier) sleep hygiene practices
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Sleep Diary Measure - Time in Bed (TIB)
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: time in bed (TIB) in hours
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Sleep Diary Measure - Total Sleep Time (TST)
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: total sleep time (TST) in hours
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Sleep Diary Measure - Sleep Onset Latency (SOL)
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: sleep onset latency (SOL) in mins
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Sleep Diary Measure - Wake After Sleep Onset (WASO)
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: wake after sleep onset (WASO) in mins
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Sleep Diary Measure - Sleep Efficiency (SE)
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: sleep efficiency (SE), which is calculated by total sleep time divided by total time in bed, %
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Objective Actigraphy - Time in Bed (TIB)
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
The duration of time spent in bed attempting to sleep, estimated from 7-night wrist actigraphy. Reported as mean minutes per night across the recording period.
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Objective Actigraphy - Total Sleep Time (TST)
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
The total amount of sleep obtained during a sleep period, estimated from 7-night wrist actigraphy. Reported as mean minutes per night across the recording period.
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Objective Actigraphy - Sleep Onset Latency (SOL)
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
The amount of time it takes to fall asleep after attempting to do so, estimated from 7-night wrist actigraphy. Reported as mean minutes per night across the recording period.
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Objective Actigraphy - Wake After Sleep Onset (WASO)
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
The amount of time spent awake after initially falling asleep, estimated from 7-night wrist actigraphy. Reported as mean minutes per night across the recording period.
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Objective Actigraphy - Sleep Midpoint Variability
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
The standard deviation of the sleep midpoint, defined as (sleep onset + sleep offset) / 2, across the 7-night recording. Higher values reflect more irregular sleep timing across nights.
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Objective Actigraphy - Sleep Efficiency (SE)
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
The percentage of time spent asleep while in bed, calculated as (TST / TIB) × 100, estimated from 7-night wrist actigraphy.
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Objective Actigraphy - Acrophase
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
The clock time of maximum activity estimated from a cosinor model fitted to the 7-day rest-activity record. Represents the timing of peak daily activity.
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Objective Actigraphy - Amplitude
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
The difference between the peak and nadir of the cosinor-fitted rest-activity curve across the 7-day recording. Reflects the overall strength of the circadian rest-activity rhythm.
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Objective Actigraphy - Intradaily Variability (IV)
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
An index ranging from 0 to 2 quantifying the degree of rest-activity rhythm fragmentation. Higher values reflect greater fragmentation, indicating more daytime napping or nocturnal awakening.
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Objective Actigraphy - Interdaily Stability (IS)
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
An index ranging from 0 to 1 reflecting the synchronisation of the rest-activity rhythm to the 24-hour light-dark cycle. Higher values reflect stronger synchronisation.
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Objective Actigraphy - L5
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
The clock time of onset of the 5 least active consecutive hours across the 7-day recording, presumed to represent the habitual sleep window.
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Objective Actigraphy - M10
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Actigraphic assessment for consecutive seven days. Circadian parameters computed by the nonparametric circadian rhythm analysis method - start times and average activity of M10 (i.e. 10 h with maximal activity).
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Objective Actigraphy - Fluctuation of the midpoint of sleep
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Actigraphic assessment for seven consecutive days. The standard deviation of the midpoint of sleep will be derived from actigraphy, defined as sleep onset + sleep offset) / 2, across the 7-night recording.
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Objective Circadian Measures: Dim-Light Melatonin Onset (DLMO) - Sleep Onset Phase angle
Zeitfenster: Baseline and Post-Treatment (one-week after treatment conclusion)
DLMO time to sleep-onset phase angle: Interval (min) from DLMO time to diary-determined sleep-onset time. Sleep-onset time will be calculated as the mean sleep-onset time across valid diary nights.
Baseline and Post-Treatment (one-week after treatment conclusion)
Objective Circadian Measures: Dim-Light Melatonin Onset (DLMO) - DLMO Timing
Zeitfenster: Baseline and Post-Treatment (one-week after treatment conclusion)

Dim-light melatonin onset (express as time value hh:mm) is determined by 6-hours salivary melatonin collected at 30-minutes interval. Melatonin is assayed by gas chromatography-mass spectrometry.

DLMO time: Clock time (hh:mm) at which salivary melatonin first exceeds the 3 pg mL-¹ threshold under < 10 lux illumination.
Baseline and Post-Treatment (one-week after treatment conclusion)
Objective Circadian Measures: Dim-Light Melatonin Onset (DLMO) - Sleep Midpoint Phase Angel
Zeitfenster: Baseline and Post-Treatment (one-week after treatment conclusion)
DLMO time to sleep-midpoint phase angle is the initerval (min) from DLMO time to diary-determined sleep midpoint. Sleep midpoint will be calculated as halfway between sleep onset and final sleep offset/waketime.
Baseline and Post-Treatment (one-week after treatment conclusion)
Dim Light Melatonin Onset - Lights-Off Phase Angel
Zeitfenster: Baseline and Post-Treatment (one-week after treatment conclusion)
Interval (min) from DLMO time to diary-determined lights-off/bedtime; indexing the timing of attempted sleep relative to biological night onset. Lights-off/bedtime will be calculated as the mean diary-reported lights-off/bedtime across valid diary nights.
Baseline and Post-Treatment (one-week after treatment conclusion)
Pupil Light Reflex - T75 Recovery Time
Zeitfenster: Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
T75 recovery time is the seconds from stimulus offset to 75% return toward baseline pupil diameter, reflecting the post-illumination pupil response (PIPR), a melanopsin-mediated circadian biomarker.
Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Polysomnography - Time in Bed
Zeitfenster: Baseline and Post-Treatment (one-week after treatment conclusion)
Objective sleep parameter derived from overnight polysomnography: time in bed (TIB) in hours, measuring the total duration from lights-out to lights-on.
Baseline and Post-Treatment (one-week after treatment conclusion)
Polysomnography - Total Sleep Time
Zeitfenster: Baseline and Post-Treatment (one-week after treatment conclusion)
Objective sleep parameter derived from overnight polysomnography: total sleep time (TST) in hours.
Baseline and Post-Treatment (one-week after treatment conclusion)
Polysomnography - Sleep Efficiency
Zeitfenster: Baseline and Post-Treatment (one-week after treatment conclusion)
Objective sleep parameter derived from overnight polysomnography: sleep efficiency (SE) expressed as a percentage, calculated as total sleep time divided by time in bed.
Baseline and Post-Treatment (one-week after treatment conclusion)
Polysomnography - Sleep Latency
Zeitfenster: Baseline and Post-Treatment (one-week after treatment conclusion)
Objective sleep parameter derived from overnight polysomnography: sleep latency in minutes, measuring the time interval from lights-off to the onset of the first scored sleep stage.
Baseline and Post-Treatment (one-week after treatment conclusion)
Polysomnography - Wake After Sleep Onset
Zeitfenster: Baseline and Post-Treatment (one-week after treatment conclusion)
Objective sleep parameter derived from overnight polysomnography: wake after sleep onset (WASO) in minutes, measuring the total duration of wakefulness recorded after initial sleep onset.
Baseline and Post-Treatment (one-week after treatment conclusion)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

The University of Hong Kong

Mitarbeiter

Chinese University of Hong Kong

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. August 2026

Primärer Abschluss (Geschätzt)

1. August 2029

Studienabschluss (Geschätzt)

1. August 2029

Studienanmeldedaten

Zuerst eingereicht

13. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. Juli 2026

Zuerst gepostet (Tatsächlich)

10. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

5. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • EA240592

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Cognitive behavioural therapy for insomnia

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Bangladesh

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

3
Abonnieren