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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Insomnia, HIV

Intervention / Treatment
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* Behavioral: CBT-I


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT-I<br>This is a single arm study in which all participants receive the intervention (cognitive behavioural therapy for insomnia) | Behavioral: CBT-I<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia symptom severity | Insomnia symptom severity is measured using the Insomnia Severity Index (ISI) | Two weeks post-treatment | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |