A Pragmatic Pilot Study of Cognitive Behavioural Therapy for Insomnia Among People Living With HIV
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Tipo di studio
Iscrizione (Effettivo)
Iscrizione
Fase
Fase
- Non applicabile
Contatti e Sedi
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
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
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
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / 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
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
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
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
Sponsor
Sponsor
Investigatori
Investigatori
- Investigatore principale: Tyler Tulloch, MA, Ryerson University
Pubblicazioni e link utili
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.
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