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

NCT ID: NCT02887209

Last Updated: 2019-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2018-11-30

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.

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.

Conditions

Insomnia; HIV

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CBT-I

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

Group Type: EXPERIMENTAL

CBT-I

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Toronto Metropolitan University

OTHER

Sponsor Role: lead

Responsible Party

Tyler Tulloch

PhD Student, Clinical Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tyler Tulloch, MA

Role: PRINCIPAL_INVESTIGATOR

Toronto Metropolitan University

Locations

Department of Psychology, Ryerson University

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 24971014 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23470897 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23744045 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22215923 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27136449 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9803968 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18853708 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23290379 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15600216 (View on PubMed)

Edinger JD, Carney, CE. Overcoming insomnia: A cognitive-behavioral therapy approach. Therapist Guide. New York: Oxford University Press, 2008.

Reference Type: 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.

Reference Type: BACKGROUND

American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). Washington, DC: Author.

Reference Type: BACKGROUND

Related Links

http://hivprevlab.ca

Lab website

Other Identifiers

PSS

Identifier Type: -

Identifier Source: org_study_id