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A Pragmatic Pilot Study of Cognitive Behavioural Therapy for Insomnia Among People Living With HIV

12. august 2019 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

10

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Ontario
      • Toronto, Ontario, Canada, M5B 2K3
        • Department of Psychology, Ryerson University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Insomnia symptom severity
Tidsramme: Two weeks post-treatment
Insomnia symptom severity is measured using the Insomnia Severity Index (ISI)
Two weeks post-treatment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
CD4+ (cluster of differentiation 4) cell count
Tidsramme: 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
Tidsramme: 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
Tidsramme: Two weeks post-treatment
Measured using the Self-Rating Scale Item (SRSI) and Simplified Medication Adherence Questionnaire (SMAQ)
Two weeks post-treatment
Sleep efficiency
Tidsramme: Two weeks post-treatment
Sleep efficiency is the amount of time spent sleeping vs. awake in bed
Two weeks post-treatment
Total wake time
Tidsramme: Two weeks post-treatment
Total wake time is the total time spent awake between getting into bed at night
Two weeks post-treatment

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Health-related quality of life
Tidsramme: Two weeks post-treatment
Measured using the Medical Outcomes Study Short-Form Health Survey (SF-36)
Two weeks post-treatment
Depression symptom severity
Tidsramme: 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
Tidsramme: Immediately post-treatment (final therapy session)
Measured using the Therapy Evaluation Questionnaire (TEQ)
Immediately post-treatment (final therapy session)
Intervention safety
Tidsramme: 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
Tidsramme: Two weeks post-treatment
Measured using the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16)
Two weeks post-treatment
Sleep effort
Tidsramme: Two weeks post-treatment
Measured using the Glasgow Sleep Effort Scale (GSES)
Two weeks post-treatment
Self-efficacy for sleep
Tidsramme: Two weeks post-treatment
Measured using the Self-Efficacy for Sleep Scale (SE-S)
Two weeks post-treatment
Pre-sleep arousal
Tidsramme: Two weeks post-treatment
Measured using the Pre-Sleep Arousal Scale (PSAS-13)
Two weeks post-treatment
Fatigue
Tidsramme: Two weeks post treatment
Measured using the Fatigue Severity Scale (FSS)
Two weeks post treatment
Anxiety Symptom Severity
Tidsramme: Two weeks post treatment
Measured using the Depression Anxiety Stress Scales (DASS-21)
Two weeks post treatment
HIV-Related Fatigue
Tidsramme: Two weeks post treatment
Measured using the HIV-Related Fatigue Scale (HRFS)
Two weeks post treatment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Tyler Tulloch, MA, Ryerson University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2016

Primær færdiggørelse (Faktiske)

1. november 2018

Studieafslutning (Faktiske)

1. november 2018

Datoer for studieregistrering

Først indsendt

29. august 2016

Først indsendt, der opfyldte QC-kriterier

1. september 2016

Først opslået (Skøn)

2. september 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. august 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. august 2019

Sidst verificeret

1. august 2019

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • PSS (Andet bevillings-/finansieringsnummer: Panaceo International Active Mineral Production GmbH)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Søvnløshed

Kliniske forsøg med CBT-I

3
Abonner