An interventional study of CBT-I in Insomnia and HIV, sponsored by Toronto Metropolitan University. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-14.
Sponsored by Toronto Metropolitan University · Not applicable, Interventional, and Treatment
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 (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.
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This study's enrollment of 10 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
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Exclusion Criteria:
This is a single arm study in which all participants receive the intervention (cognitive behavioural therapy for insomnia)
Behavioral: CBT-I
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.
Insomnia symptom severity
Insomnia symptom severity is measured using the Insomnia Severity Index (ISI)
Time frame: Two weeks post-treatment
CD4+ (cluster of differentiation 4) cell count
Obtained via self-report based on blood test results in past 3 months
Time frame: Within two months post-treatment
HIV viral load
Obtained via self-report based on blood test results in past 3 months
Time frame: 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)
Time frame: Two weeks post-treatment
Sleep efficiency
Sleep efficiency is the amount of time spent sleeping vs. awake in bed
Time frame: Two weeks post-treatment
Total wake time
Total wake time is the total time spent awake between getting into bed at night
Time frame: Two weeks post-treatment
Health-related quality of life
Measured using the Medical Outcomes Study Short-Form Health Survey (SF-36)
Time frame: 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)
Time frame: Two weeks post-treatment
Treatment acceptability
Measured using the Therapy Evaluation Questionnaire (TEQ)
Time frame: Immediately post-treatment (final therapy session)
Intervention safety
Measured via qualitative exit interview, and includes any unwanted or adverse events associated with the intervention
Time frame: Two weeks post-treatment
Dysfunctional beliefs about sleep
Measured using the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16)
Time frame: Two weeks post-treatment
Sleep effort
Measured using the Glasgow Sleep Effort Scale (GSES)
Time frame: Two weeks post-treatment
Self-efficacy for sleep
Measured using the Self-Efficacy for Sleep Scale (SE-S)
Time frame: Two weeks post-treatment
Pre-sleep arousal
Measured using the Pre-Sleep Arousal Scale (PSAS-13)
Time frame: Two weeks post-treatment
Fatigue
Measured using the Fatigue Severity Scale (FSS)
Time frame: Two weeks post treatment
Anxiety Symptom Severity
Measured using the Depression Anxiety Stress Scales (DASS-21)
Time frame: Two weeks post treatment
HIV-Related Fatigue
Measured using the HIV-Related Fatigue Scale (HRFS)
Time frame: Two weeks post treatment
Plan to share: No
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Toronto Metropolitan University