- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02887209
A Pragmatic Pilot Study of Cognitive Behavioural Therapy for Insomnia Among People Living With HIV
12. August 2019 aktualisiert von: Tyler Tulloch, Ryerson University
Insomnia is a problem for approximately 75% of people living with HIV, which is much higher than the 6% to 10% of people with insomnia in the general population.
It is currently unknown why the rate of insomnia is so high among people living with HIV, and because of this, they are often excluded from clinical trials examining the usefulness of cognitive behavioural therapy for insomnia (CBT-I), which is recommended as the first-line treatment for insomnia.
Insomnia is also associated with poorer immune functioning and lower medication adherence.
The purpose of this study is to examine whether CBT-I is useful at reducing insomnia among people living with HIV, and to examine whether this counselling is safe to provide to this population.
Other purposes are to explore whether reducing insomnia will lead to improved immune functioning and medication adherence, to collect feedback about people's experiences receiving CBT-I, to examine which psychological and behavioural factors are associated with insomnia severity among people living with HIV.
Studienübersicht
Detaillierte Beschreibung
The prevalence of insomnia in the general population ranges from 6% to 10% (American Psychiatric Association, 2013), whereas its estimated prevalence among people living with HIV (PWH) is 73% (Rubinstein & Selwyn, 1998).
Cognitive, behavioural, physiological, and psychosocial explanations for this elevated prevalence have been proposed (Taibi, 2013), however, there is a lack of consensus in the literature.
Sleep disturbance is associated with disrupted immune functioning at the cellular level (Taylor, Lichstein, & Durrence, 2003), as well as increased risk of contracting infectious diseases (Patel et al., 2012); therefore, insomnia may be particularly problematic for PWH.
Cognitive behavioural therapy for insomnia (CBT-I; Edinger & Carney, 2008) is the first-line treatment for insomnia (Qaseem et al., 2016; Schutte-Rodin et al., 2008), and medium to large effect sizes have been reported (Okajima et al., 2011).
CBT-I is effective at treating insomnia among individuals with comorbid medical disorders such as chronic pain (Jungquist et al., 2012), fibromyalgia (Martínez et al., 2014), and cancer (Garland et al., 2014).
Surprisingly, no study to date has examined the efficacy of CBT-I among PWH.
The current study will evaluate the safety, feasibility, acceptability, and effects of CBT-I among 20 PWH using a pragmatic pilot study design.
An exit interview will be conducted to elicit participant feedback about the treatment and methods used.
Additional cross-sectional analyses will examine predictors of insomnia symptom severity and other sleep-related outcomes among a larger sample (n = 60).
This will be the first study to examine the impact of CBT-I among PWH.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
10
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Ontario
-
Toronto, Ontario, Kanada, M5B 2K3
- Department of Psychology, Ryerson University
-
-
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
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- 18 years of age or older
- able to understand and communicate in English
- capable of providing informed consent
- presence of insomnia based on screener questionnaire cutoff score ≥ 15 on the Insomnia Severity Index
- HIV-seropositive
- willing to provide HIV viral load and CD4 count from blood work within the past two months
Exclusion Criteria:
- active suicidal ideation
- psychotic symptoms
- unmanaged bipolar disorder
- presence of a severe alcohol or substance use disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria
- hypnotic dependence
- presence of any breathing-related sleep disorders (obstructive sleep apnea hypopnea, central sleep apnea, and sleep-related hypoventilation), or circadian rhythm sleep-wake disorders
- working shift work or frequent time zone travel over the course of the study
- contingent or inconsistent hypnotic use, or anticipated change in hypnotic medication dose over the course of the study
- receiving psychotherapy for insomnia or any other mental disorder over the course of the study
- presence of an AIDS-defining opportunistic infection and/or a CD4 count < 200
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: CBT-I
This is a single arm study in which all participants receive the intervention (cognitive behavioural therapy for insomnia)
|
Cognitive behavioural therapy for insomnia (CBT-I; Edinger & Carney, 2008) is a standard 4-session cognitive behavioural therapy for insomnia administered biweekly in individual format.
The first session involves presenting treatment rationale and introducing a behavioural treatment regimen consisting of a series of sleep habit parameters to follow, and determining a personalized "time in bed" prescription.
The second session involves reviewing past-week sleep diary, discussing the role of cognitions in insomnia, and discussing constructive worrying techniques and the use of thought records.
The third and fourth sessions are used to assist in adjusting "time in bed" prescriptions, to positively reinforce efforts, and to help problem-solve any problems they might have encountered.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Insomnia symptom severity
Zeitfenster: Two weeks post-treatment
|
Insomnia symptom severity is measured using the Insomnia Severity Index (ISI)
|
Two weeks post-treatment
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
CD4+ (cluster of differentiation 4) cell count
Zeitfenster: Within two months post-treatment
|
Obtained via self-report based on blood test results in past 3 months
|
Within two months post-treatment
|
HIV viral load
Zeitfenster: Within two months post-treatment
|
Obtained via self-report based on blood test results in past 3 months
|
Within two months post-treatment
|
Combined antiretroviral therapy (cART) medication adherence
Zeitfenster: Two weeks post-treatment
|
Measured using the Self-Rating Scale Item (SRSI) and Simplified Medication Adherence Questionnaire (SMAQ)
|
Two weeks post-treatment
|
Sleep efficiency
Zeitfenster: Two weeks post-treatment
|
Sleep efficiency is the amount of time spent sleeping vs. awake in bed
|
Two weeks post-treatment
|
Total wake time
Zeitfenster: Two weeks post-treatment
|
Total wake time is the total time spent awake between getting into bed at night
|
Two weeks post-treatment
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Health-related quality of life
Zeitfenster: Two weeks post-treatment
|
Measured using the Medical Outcomes Study Short-Form Health Survey (SF-36)
|
Two weeks post-treatment
|
Depression symptom severity
Zeitfenster: Two weeks post-treatment
|
Measured using the Centre for Epidemiological Studies in Depression Scale-Revised (CESD-R) and Depression Anxiety Stress Scales (DASS-21)
|
Two weeks post-treatment
|
Treatment acceptability
Zeitfenster: Immediately post-treatment (final therapy session)
|
Measured using the Therapy Evaluation Questionnaire (TEQ)
|
Immediately post-treatment (final therapy session)
|
Intervention safety
Zeitfenster: Two weeks post-treatment
|
Measured via qualitative exit interview, and includes any unwanted or adverse events associated with the intervention
|
Two weeks post-treatment
|
Dysfunctional beliefs about sleep
Zeitfenster: Two weeks post-treatment
|
Measured using the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16)
|
Two weeks post-treatment
|
Sleep effort
Zeitfenster: Two weeks post-treatment
|
Measured using the Glasgow Sleep Effort Scale (GSES)
|
Two weeks post-treatment
|
Self-efficacy for sleep
Zeitfenster: Two weeks post-treatment
|
Measured using the Self-Efficacy for Sleep Scale (SE-S)
|
Two weeks post-treatment
|
Pre-sleep arousal
Zeitfenster: Two weeks post-treatment
|
Measured using the Pre-Sleep Arousal Scale (PSAS-13)
|
Two weeks post-treatment
|
Fatigue
Zeitfenster: Two weeks post treatment
|
Measured using the Fatigue Severity Scale (FSS)
|
Two weeks post treatment
|
Anxiety Symptom Severity
Zeitfenster: Two weeks post treatment
|
Measured using the Depression Anxiety Stress Scales (DASS-21)
|
Two weeks post treatment
|
HIV-Related Fatigue
Zeitfenster: Two weeks post treatment
|
Measured using the HIV-Related Fatigue Scale (HRFS)
|
Two weeks post treatment
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Tyler Tulloch, MA, Ryerson University
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- Garland SN, Johnson JA, Savard J, Gehrman P, Perlis M, Carlson L, Campbell T. Sleeping well with cancer: a systematic review of cognitive behavioral therapy for insomnia in cancer patients. Neuropsychiatr Dis Treat. 2014 Jun 18;10:1113-24. doi: 10.2147/NDT.S47790. eCollection 2014.
- Jungquist CR, Tra Y, Smith MT, Pigeon WR, Matteson-Rusby S, Xia Y, Perlis ML. The durability of cognitive behavioral therapy for insomnia in patients with chronic pain. Sleep Disord. 2012;2012:679648. doi: 10.1155/2012/679648. Epub 2012 Aug 9.
- Martinez MP, Miro E, Sanchez AI, Diaz-Piedra C, Caliz R, Vlaeyen JW, Buela-Casal G. Cognitive-behavioral therapy for insomnia and sleep hygiene in fibromyalgia: a randomized controlled trial. J Behav Med. 2014 Aug;37(4):683-97. doi: 10.1007/s10865-013-9520-y. Epub 2013 Jun 7.
- Patel SR, Malhotra A, Gao X, Hu FB, Neuman MI, Fawzi WW. A prospective study of sleep duration and pneumonia risk in women. Sleep. 2012 Jan 1;35(1):97-101. doi: 10.5665/sleep.1594.
- Qaseem A, Kansagara D, Forciea MA, Cooke M, Denberg TD; Clinical Guidelines Committee of the American College of Physicians. Management of Chronic Insomnia Disorder in Adults: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2016 Jul 19;165(2):125-33. doi: 10.7326/M15-2175. Epub 2016 May 3.
- Rubinstein ML, Selwyn PA. High prevalence of insomnia in an outpatient population with HIV infection. J Acquir Immune Defic Syndr Hum Retrovirol. 1998 Nov 1;19(3):260-5. doi: 10.1097/00042560-199811010-00008.
- Schutte-Rodin S, Broch L, Buysse D, Dorsey C, Sateia M. Clinical guideline for the evaluation and management of chronic insomnia in adults. J Clin Sleep Med. 2008 Oct 15;4(5):487-504.
- Taibi DM. Sleep disturbances in persons living with HIV. J Assoc Nurses AIDS Care. 2013 Jan-Feb;24(1 Suppl):S72-85. doi: 10.1016/j.jana.2012.10.006.
- Taylor DJ, Lichstein KL, Durrence HH. Insomnia as a health risk factor. Behav Sleep Med. 2003;1(4):227-47. doi: 10.1207/S15402010BSM0104_5.
- Edinger JD, Carney, CE. Overcoming insomnia: A cognitive-behavioral therapy approach. Therapist Guide. New York: Oxford University Press, 2008.
- Okajima I, Komada Y, Inoue Y. A meta-analysis on the treatment effectiveness of cognitive behavioral therapy for primary insomnia. Sleep and Biological Rhythms 9(1): 24-34, 2011.
- American Psychiatric Association. (2013). Diagnostic and Statistical Manual of Mental Disorders (5th ed.). Washington, DC: Author.
Nützliche Links
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
1. September 2016
Primärer Abschluss (Tatsächlich)
1. November 2018
Studienabschluss (Tatsächlich)
1. November 2018
Studienanmeldedaten
Zuerst eingereicht
29. August 2016
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
1. September 2016
Zuerst gepostet (Schätzen)
2. September 2016
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
14. August 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
12. August 2019
Zuletzt verifiziert
1. August 2019
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- PSS (Andere Zuschuss-/Finanzierungsnummer: Panaceo International Active Mineral Production GmbH)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
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 CBT-I
-
Indiana UniversityIndiana Clinical and Translational Sciences InstituteBeendetChronischer Schmerz | SchlaflosigkeitVereinigte Staaten
-
Chinese University of Hong KongRekrutierungSchlaflosigkeit | Angst | JugendHongkong
-
VA Office of Research and DevelopmentVA Finger Lakes Healthcare SystemRekrutierungSchlaflosigkeitVereinigte Staaten
-
University of ArizonaAmerican Academy of Sleep MedicineUnbekannt
-
VA Office of Research and DevelopmentBeendetSchlafeinleitungs- und -erhaltungsstörungen | Marihuana-MissbrauchVereinigte Staaten
-
The University of Hong KongChinese University of Hong Kong; Stanford University; Goldsmiths, University of...RekrutierungSchlaflosigkeit | AngstHongkong
-
VA Office of Research and DevelopmentAktiv, nicht rekrutierendSchlaflosigkeit | Schädel-Hirn-TraumaVereinigte Staaten
-
Karolinska InstitutetRegion StockholmAbgeschlossenPTBS | Angststörungen | Affektive Störungen | Chronische SchlaflosigkeitSchweden
-
Ottawa Heart Institute Research CorporationBeendetHerz-Kreislauf-Erkrankungen | SchlaflosigkeitKanada
-
The University of Hong KongChinese University of Hong Kong; Stanford UniversityRekrutierungDepression | Schlaflosigkeit | Schwangerschaft bezogenHongkong