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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.
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 (MartÃnez 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT-I | Experimental | This is a single arm study in which all participants receive the intervention (cognitive behavioural therapy for insomnia) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT-I | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia symptom severity | Insomnia symptom severity is measured using the Insomnia Severity Index (ISI) | Two weeks post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| CD4+ (cluster of differentiation 4) cell count | Obtained via self-report based on blood test results in past 3 months | Within two months post-treatment |
| HIV viral load | Obtained via self-report based on blood test results in past 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Health-related quality of life | Measured using the Medical Outcomes Study Short-Form Health Survey (SF-36) | Two weeks post-treatment |
| Depression symptom severity | Measured using the Centre for Epidemiological Studies in Depression Scale-Revised (CESD-R) and Depression Anxiety Stress Scales (DASS-21) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tyler Tulloch, MA | Toronto Metropolitan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychology, Ryerson University | Toronto | Ontario | M5B 2K3 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24971014 | Background | 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. | |
| 23470897 | Background | 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. |
| Label | URL |
|---|---|
| Lab website | View source |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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|
| Within two months post-treatment |
| Combined antiretroviral therapy (cART) medication adherence | Measured using the Self-Rating Scale Item (SRSI) and Simplified Medication Adherence Questionnaire (SMAQ) | Two weeks post-treatment |
| Sleep efficiency | Sleep efficiency is the amount of time spent sleeping vs. awake in bed | Two weeks post-treatment |
| Total wake time | Total wake time is the total time spent awake between getting into bed at night | Two weeks post-treatment |
| Two weeks post-treatment |
| Treatment acceptability | Measured using the Therapy Evaluation Questionnaire (TEQ) | Immediately post-treatment (final therapy session) |
| Intervention safety | Measured via qualitative exit interview, and includes any unwanted or adverse events associated with the intervention | Two weeks post-treatment |
| Dysfunctional beliefs about sleep | Measured using the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16) | Two weeks post-treatment |
| Sleep effort | Measured using the Glasgow Sleep Effort Scale (GSES) | Two weeks post-treatment |
| Self-efficacy for sleep | Measured using the Self-Efficacy for Sleep Scale (SE-S) | Two weeks post-treatment |
| Pre-sleep arousal | Measured using the Pre-Sleep Arousal Scale (PSAS-13) | Two weeks post-treatment |
| Fatigue | Measured using the Fatigue Severity Scale (FSS) | Two weeks post treatment |
| Anxiety Symptom Severity | Measured using the Depression Anxiety Stress Scales (DASS-21) | Two weeks post treatment |
| HIV-Related Fatigue | Measured using the HIV-Related Fatigue Scale (HRFS) | Two weeks post treatment |
| 23744045 | Background | 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. |
| 22215923 | Background | 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. |
| 27136449 | Background | 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. |
| 9803968 | Background | 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. |
| 18853708 | Background | 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. |
| 23290379 | Background | 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. |
| 15600216 | Background | 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. |
| Background | Edinger JD, Carney, CE. Overcoming insomnia: A cognitive-behavioral therapy approach. Therapist Guide. New York: Oxford University Press, 2008. |
| Background | 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. |
| Background | American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). Washington, DC: Author. |
| D001523 |
| Mental Disorders |