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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

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

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.

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

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

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

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