Clinical trial NCT02887209: A Pragmatic Pilot Study of Cognitive Behavioural Therapy for Insomnia Among People Living With HIV
Official title: A Pragmatic Pilot Study of Cognitive Behavioural Therapy for Insomnia Among People Living With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
HIV
Lead sponsor: Toronto Metropolitan University
Sponsor class: OTHER
First posted: 2016-09-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Insomnia symptom severity
timeFrame: Two weeks post-treatment
Secondary outcomes:
measure: CD4+ (cluster of differentiation 4) cell count
timeFrame: Within two months post-treatment
measure: HIV viral load
timeFrame: Within two months post-treatment
measure: Combined antiretroviral therapy (cART) medication adherence
timeFrame: Two weeks post-treatment
measure: Sleep efficiency
timeFrame: Two weeks post-treatment
measure: Total wake time
timeFrame: Two weeks post-treatment
Other outcomes:
measure: Health-related quality of life
timeFrame: Two weeks post-treatment
measure: Depression symptom severity
timeFrame: Two weeks post-treatment
measure: Treatment acceptability
timeFrame: Immediately post-treatment (final therapy session)
measure: Intervention safety
timeFrame: Two weeks post-treatment
measure: Dysfunctional beliefs about sleep
timeFrame: Two weeks post-treatment
measure: Sleep effort
timeFrame: Two weeks post-treatment
measure: Self-efficacy for sleep
timeFrame: Two weeks post-treatment
measure: Pre-sleep arousal
timeFrame: Two weeks post-treatment
measure: Fatigue
timeFrame: Two weeks post treatment
measure: Anxiety Symptom Severity
timeFrame: Two weeks post treatment
measure: HIV-Related Fatigue
timeFrame: Two weeks post treatment
Locations:
city: Toronto
country: Canada
facility: Department of Psychology, Ryerson University
state: Ontario
Study officials:
affiliation: Toronto Metropolitan University
name: Tyler Tulloch, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Edinger JD, Carney, CE. Overcoming insomnia: A cognitive-behavioral therapy approach. Therapist Guide. New York: Oxford University Press, 2008.
citation: 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.
citation: American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). Washington, DC: Author.