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

Toronto Metropolitan University

Status: Completed

Conditions: HIV; Insomnia

Treatments: Behavioral: CBT-I

Study type: Interventional

Funder types: Other

Identifiers

NCT02887209

PSS (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

CBT-I

Experimental group

Description:

This is a single arm study in which all participants receive the intervention (cognitive behavioural therapy for insomnia)

Treatment:

Behavioral: CBT-I