A Pragmatic Pilot Study of Cognitive Behavioural Therapy for Insomnia Among People Living With HIV
12 août 2019 mis à jour par: 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.
Aperçu de l'étude
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
10
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Ontario
-
Toronto, Ontario, Canada, M5B 2K3
- Department of Psychology, Ryerson University
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Insomnia symptom severity
Délai: Two weeks post-treatment
|
Insomnia symptom severity is measured using the Insomnia Severity Index (ISI)
|
Two weeks post-treatment
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
CD4+ (cluster of differentiation 4) cell count
Délai: 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
Délai: 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
Délai: Two weeks post-treatment
|
Measured using the Self-Rating Scale Item (SRSI) and Simplified Medication Adherence Questionnaire (SMAQ)
|
Two weeks post-treatment
|
|
Sleep efficiency
Délai: Two weeks post-treatment
|
Sleep efficiency is the amount of time spent sleeping vs. awake in bed
|
Two weeks post-treatment
|
|
Total wake time
Délai: Two weeks post-treatment
|
Total wake time is the total time spent awake between getting into bed at night
|
Two weeks post-treatment
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Health-related quality of life
Délai: Two weeks post-treatment
|
Measured using the Medical Outcomes Study Short-Form Health Survey (SF-36)
|
Two weeks post-treatment
|
|
Depression symptom severity
Délai: 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
Délai: Immediately post-treatment (final therapy session)
|
Measured using the Therapy Evaluation Questionnaire (TEQ)
|
Immediately post-treatment (final therapy session)
|
|
Intervention safety
Délai: 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
Délai: Two weeks post-treatment
|
Measured using the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16)
|
Two weeks post-treatment
|
|
Sleep effort
Délai: Two weeks post-treatment
|
Measured using the Glasgow Sleep Effort Scale (GSES)
|
Two weeks post-treatment
|
|
Self-efficacy for sleep
Délai: Two weeks post-treatment
|
Measured using the Self-Efficacy for Sleep Scale (SE-S)
|
Two weeks post-treatment
|
|
Pre-sleep arousal
Délai: Two weeks post-treatment
|
Measured using the Pre-Sleep Arousal Scale (PSAS-13)
|
Two weeks post-treatment
|
|
Fatigue
Délai: Two weeks post treatment
|
Measured using the Fatigue Severity Scale (FSS)
|
Two weeks post treatment
|
|
Anxiety Symptom Severity
Délai: Two weeks post treatment
|
Measured using the Depression Anxiety Stress Scales (DASS-21)
|
Two weeks post treatment
|
|
HIV-Related Fatigue
Délai: Two weeks post treatment
|
Measured using the HIV-Related Fatigue Scale (HRFS)
|
Two weeks post treatment
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Tyler Tulloch, MA, Ryerson University
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 septembre 2016
Achèvement primaire (Réel)
1 novembre 2018
Achèvement de l'étude (Réel)
1 novembre 2018
Dates d'inscription aux études
Première soumission
29 août 2016
Première soumission répondant aux critères de contrôle qualité
1 septembre 2016
Première publication (Estimation)
2 septembre 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
14 août 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
12 août 2019
Dernière vérification
1 août 2019
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PSS (Autre subvention/numéro de financement: Panaceo International Active Mineral Production GmbH)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .