- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02887209
A Pragmatic Pilot Study of Cognitive Behavioural Therapy for Insomnia Among People Living With HIV
12 agosto 2019 aggiornato da: 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.
Panoramica dello studio
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
10
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Ontario
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Toronto, Ontario, Canada, M5B 2K3
- Department of Psychology, Ryerson University
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: CBT-I
This is a single arm study in which all participants receive the intervention (cognitive behavioural therapy for insomnia)
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Insomnia symptom severity
Lasso di tempo: Two weeks post-treatment
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Insomnia symptom severity is measured using the Insomnia Severity Index (ISI)
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Two weeks post-treatment
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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CD4+ (cluster of differentiation 4) cell count
Lasso di tempo: Within two months post-treatment
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Obtained via self-report based on blood test results in past 3 months
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Within two months post-treatment
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HIV viral load
Lasso di tempo: Within two months post-treatment
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Obtained via self-report based on blood test results in past 3 months
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Within two months post-treatment
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Combined antiretroviral therapy (cART) medication adherence
Lasso di tempo: Two weeks post-treatment
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Measured using the Self-Rating Scale Item (SRSI) and Simplified Medication Adherence Questionnaire (SMAQ)
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Two weeks post-treatment
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Sleep efficiency
Lasso di tempo: Two weeks post-treatment
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Sleep efficiency is the amount of time spent sleeping vs. awake in bed
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Two weeks post-treatment
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Total wake time
Lasso di tempo: Two weeks post-treatment
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Total wake time is the total time spent awake between getting into bed at night
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Two weeks post-treatment
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Health-related quality of life
Lasso di tempo: Two weeks post-treatment
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Measured using the Medical Outcomes Study Short-Form Health Survey (SF-36)
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Two weeks post-treatment
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Depression symptom severity
Lasso di tempo: Two weeks post-treatment
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Measured using the Centre for Epidemiological Studies in Depression Scale-Revised (CESD-R) and Depression Anxiety Stress Scales (DASS-21)
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Two weeks post-treatment
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Treatment acceptability
Lasso di tempo: Immediately post-treatment (final therapy session)
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Measured using the Therapy Evaluation Questionnaire (TEQ)
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Immediately post-treatment (final therapy session)
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Intervention safety
Lasso di tempo: Two weeks post-treatment
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Measured via qualitative exit interview, and includes any unwanted or adverse events associated with the intervention
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Two weeks post-treatment
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Dysfunctional beliefs about sleep
Lasso di tempo: Two weeks post-treatment
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Measured using the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16)
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Two weeks post-treatment
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Sleep effort
Lasso di tempo: Two weeks post-treatment
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Measured using the Glasgow Sleep Effort Scale (GSES)
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Two weeks post-treatment
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Self-efficacy for sleep
Lasso di tempo: Two weeks post-treatment
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Measured using the Self-Efficacy for Sleep Scale (SE-S)
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Two weeks post-treatment
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Pre-sleep arousal
Lasso di tempo: Two weeks post-treatment
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Measured using the Pre-Sleep Arousal Scale (PSAS-13)
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Two weeks post-treatment
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Fatigue
Lasso di tempo: Two weeks post treatment
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Measured using the Fatigue Severity Scale (FSS)
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Two weeks post treatment
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Anxiety Symptom Severity
Lasso di tempo: Two weeks post treatment
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Measured using the Depression Anxiety Stress Scales (DASS-21)
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Two weeks post treatment
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HIV-Related Fatigue
Lasso di tempo: Two weeks post treatment
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Measured using the HIV-Related Fatigue Scale (HRFS)
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Two weeks post treatment
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Tyler Tulloch, MA, Ryerson University
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 settembre 2016
Completamento primario (Effettivo)
1 novembre 2018
Completamento dello studio (Effettivo)
1 novembre 2018
Date di iscrizione allo studio
Primo inviato
29 agosto 2016
Primo inviato che soddisfa i criteri di controllo qualità
1 settembre 2016
Primo Inserito (Stima)
2 settembre 2016
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
14 agosto 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
12 agosto 2019
Ultimo verificato
1 agosto 2019
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- PSS (Altro numero di sovvenzione/finanziamento: Panaceo International Active Mineral Production GmbH)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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