We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02887209
Recruitment Status : Completed
First Posted : September 2, 2016
Last Update Posted : August 14, 2019
Information provided by (Responsible Party):
Tyler Tulloch, Ryerson University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Insomnia HIV Behavioral: CBT-I Not Applicable

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pragmatic Pilot Study of Cognitive Behavioural Therapy for Insomnia Among People Living With HIV
Study Start Date : September 2016
Actual Primary Completion Date : November 2018
Actual Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: CBT-I
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.

Primary Outcome Measures :
  1. Insomnia symptom severity [ Time Frame: Two weeks post-treatment ]
    Insomnia symptom severity is measured using the Insomnia Severity Index (ISI)

Secondary Outcome Measures :
  1. CD4+ (cluster of differentiation 4) cell count [ Time Frame: Within two months post-treatment ]
    Obtained via self-report based on blood test results in past 3 months

  2. HIV viral load [ Time Frame: Within two months post-treatment ]
    Obtained via self-report based on blood test results in past 3 months

  3. Combined antiretroviral therapy (cART) medication adherence [ Time Frame: Two weeks post-treatment ]
    Measured using the Self-Rating Scale Item (SRSI) and Simplified Medication Adherence Questionnaire (SMAQ)

  4. Sleep efficiency [ Time Frame: Two weeks post-treatment ]
    Sleep efficiency is the amount of time spent sleeping vs. awake in bed

  5. Total wake time [ Time Frame: Two weeks post-treatment ]
    Total wake time is the total time spent awake between getting into bed at night

Other Outcome Measures:
  1. Health-related quality of life [ Time Frame: Two weeks post-treatment ]
    Measured using the Medical Outcomes Study Short-Form Health Survey (SF-36)

  2. Depression symptom severity [ Time Frame: Two weeks post-treatment ]
    Measured using the Centre for Epidemiological Studies in Depression Scale-Revised (CESD-R) and Depression Anxiety Stress Scales (DASS-21)

  3. Treatment acceptability [ Time Frame: Immediately post-treatment (final therapy session) ]
    Measured using the Therapy Evaluation Questionnaire (TEQ)

  4. Intervention safety [ Time Frame: Two weeks post-treatment ]
    Measured via qualitative exit interview, and includes any unwanted or adverse events associated with the intervention

  5. Dysfunctional beliefs about sleep [ Time Frame: Two weeks post-treatment ]
    Measured using the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16)

  6. Sleep effort [ Time Frame: Two weeks post-treatment ]
    Measured using the Glasgow Sleep Effort Scale (GSES)

  7. Self-efficacy for sleep [ Time Frame: Two weeks post-treatment ]
    Measured using the Self-Efficacy for Sleep Scale (SE-S)

  8. Pre-sleep arousal [ Time Frame: Two weeks post-treatment ]
    Measured using the Pre-Sleep Arousal Scale (PSAS-13)

  9. Fatigue [ Time Frame: Two weeks post treatment ]
    Measured using the Fatigue Severity Scale (FSS)

  10. Anxiety Symptom Severity [ Time Frame: Two weeks post treatment ]
    Measured using the Depression Anxiety Stress Scales (DASS-21)

  11. HIV-Related Fatigue [ Time Frame: Two weeks post treatment ]
    Measured using the HIV-Related Fatigue Scale (HRFS)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02887209

Layout table for location information
Canada, Ontario
Department of Psychology, Ryerson University
Toronto, Ontario, Canada, M5B 2K3
Sponsors and Collaborators
Ryerson University
Layout table for investigator information
Principal Investigator: Tyler Tulloch, MA Ryerson University
Additional Information:
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.

Layout table for additonal information
Responsible Party: Tyler Tulloch, PhD Student, Clinical Psychology, Ryerson University
ClinicalTrials.gov Identifier: NCT02887209    
Other Study ID Numbers: PSS
First Posted: September 2, 2016    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders