A Sleep Program to Improve Sleep Quality in People With HIV

Insomnia Disorder Clinical Trial

Official title:

Efficacy Potential of an Internet-based Sleep Program to Improve Sleep Quality in People With HIV

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02571595
• Other study ID #: 14-368-BMB
• Secondary ID: CTN S 290
• Status: Terminated
• Phase: N/A
• Start date: May 2015
• Est. completion date: August 2020

Study information

• Verified date: August 2020
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Sleep problems, such as insomnia, are more frequent and intense in individuals living with HIV. These sleep difficulties can increase the difficulties in thinking and concentrating. Digital cognitive behavioral therapy for insomnia (dCBT-I) is a computer-based treatment intervention that provides strategies to improve sleep. This intervention has been shown to improve sleep and daytime function (concentration, productivity) in people with insomnia. However, the effects of this intervention in people living with HIV are unknown.

Description:

Sleep disturbances have been consistently reported in HIV+ individuals, and occur early in the course of infection. Among disorders of sleep commonly found in HIV, insomnia is by far the most frequent condition, affecting almost 75% of HIV-infected individuals. Compared to non-infected individuals, HIV+ patients are 17% more likely to develop insomnia. Furthermore, not only is insomnia more frequent in HIV; it is also more severe in HIV+ compared to HIV- individuals. The precise mechanisms underlying the vulnerability of this population to insomnia still remain hypothetical, and might involve neurodegenerative processes related to the infection, associated mood disorders (e.g., depression, anxiety), side effects of antiretroviral medications, and psychosocial factors. Importantly, sleep disorders in HIV have been demonstrated to affect the severity of the infection. For instance, sleep disturbances were shown to mediate the association between psychological distress and immune status (T-cytotoxic/suppressor cell counts). In addition, sleep disruption also affects responses to treatment, as illustrated by a report demonstrating that sleep disturbances mediate the association between medication adherence and self-reported HIV symptom severity. Finally, insomnia in HIV seems to be closely associated with the presence of cognitive disturbances. Indeed, virtually all HIV infected individuals with cognitive impairment present insomnia complaints, and greater sleep disturbances were associated with worse cognitive performance (e.g., executive functions, psychomotor speed) in this population. Therefore, insomnia has been shown to affect symptom severity, treatment adherence and cognition in HIV+ individuals.

Despite this demonstrated importance of sleep for the well-being of HIV patients, there are very few studies of sleep treatment interventions in HIV. Two studies have implemented an educational intervention promoting healthy sleep habits (e.g., healthy diet, reduced caffeine consumption, no exercise before bedtime, regular sleep-wake schedules), consisting of either one single session or 10 weekly sessions, with little or no consistent sleep improvement in this population. This is not surprising given that previous studies showed the very limited efficacy of interventions focusing solely on sleep hygiene in a general chronic insomnia population.

The most effective treatment for chronic insomnia currently consists of a multimodal psychological intervention, called cognitive-behavioral therapy for insomnia (CBT-I). CBT-I improves sleep to the same degree as hypnotic medications in the short term, but, in contrast to hypnotics, shows no side effects and remains effective in the long term, with sustained improvement in sleep and daytime functioning up to 2 years after completion of the therapy. CBT-I has proven effective in patients with primary insomnia (i.e. without associated medical condition), as well as in insomnia comorbid with depression or cancer. However, the efficacy of CBT-I has not been studied in HIV+ individuals with insomnia.

Digital Cognitive-Behavioural Therapy for Insomnia (CBT-I): the Sleepio program

CBT-I is an intervention aimed at breaking the patterns of maladaptive thinking and behavior that serve to maintain insomnia. It includes a range of techniques including a behavioral component (stimulus control, sleep restriction, relaxation) combined with a cognitive (managing sleep related worries, the racing mind and intrusive thoughts) and an educational (sleep hygiene) component. CBT-I is usually dispensed in group sessions, including 5 to 8 patients and a trained therapist. The different components of CBT-I are then covered in 6 to 8 weekly sessions of 60-90 minutes each. While CBT-I has been demonstrated as an efficacious treatment option, the personnel-intensive nature of CBT-I constitutes an important barrier to widespread clinical use.

Web-based (digital) CBT-I has been developed to overcome this barrier. Two randomized controlled trials (RCT) have evaluated separate digital CBT-I (dCBT-I) applications. In a first study, a six-week wait-list controlled trial of self-help dCBT-I was tested via a simple web-based platform delivering CBT-I content. Insomnia improvement was significantly better in the dCBT-I group when compared to wait-list control, at 4 weeks follow-up. In addition, 48 weeks following the intervention, within-subjects improvements in insomnia severity were also observed. The second RCT of CBT-I included a six-week placebo-controlled dCBT-I intervention, using a media rich, interactive application with an online discussion forum for users. This platform, named Sleepio (www.sleepio.com), allowed users to receive weekly, interactive sessions with an online virtual therapist. That RCT showed large effects on sleep efficiency (d=1.00) and insomnia severity (using the Sleep Condition Indicator (SCI) scale, d= .77), relative to the placebo control, at 8 week follow-up. Overall more than 75% of patients responded to the intervention, as defined by the recovery of healthy sleep efficiency levels. In addition, dCBT-I also significantly improved daytime function, including self-reported assessment of concentration and productivity, thereby suggesting a potential benefit of CBT-I for cognitive functions.

The current intervention sub-study will test the Sleepio dCBT-I intervention in people with HIV. Free access will be provided to the Sleepio program. The program will be delivered entirely online, in 6 weekly sessions spread over 6-12 weeks. The CBT-I sessions will be delivered by an animated virtual therapist, "The Prof". At the start of therapy, participants will complete a short questionnaire, which will be used to suggest examples of goals. Participants will be encouraged to complete a daily sleep diary online throughout the entire course, which will be used to provide personalized help. Indeed, all interactions with the virtual therapist will be dynamically driven by information from daily sleep diaries completed by the user, to provide baseline, adherence, performance and progress data; sleep diary information will also be used to tailor sleep restriction schedules as a function of to the patients' usual bedtimes. Within each therapy session, sleep diary data will be reviewed, goals will be reviewed and new targets will be set. The treatment content will be based on CBT for insomnia manuals and includes the following techniques: psycho-education, goal setting, sleep hygiene, sleep restriction, stimulus control, cognitive restructuring, paradoxical intention, mindfulness, positive imagery, relaxation (progressive muscle relaxation & autogenic training), putting the day to rest, thought stopping. Participants will be encouraged to select an appointment time for the Sleepio session and will be prompted via email if they do not attend. In addition, participants will receive an email reminder each morning to prompt them to fill in their sleep diary and will have access to a moderated online community and an online library of information about sleep throughout the course of the intervention. They will be able to view their online 'case file' which includes four sections: a progress review, a reminder of strategies to try out in between sessions, an agreed sleep schedule and a list of further reading. In addition to the Sleepio program, participants will be asked to complete a short set of questionnaires assessing mood, quality of life, cognitive symptoms and sleep quality via an online link prior at the start and end of the program, and at their next routine (main study) follow-up visit.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

• Evidence of insomnia disorder (Sleep Condition Indicator [SCI] = 16)

• Able to have convenient weekly access to the Internet

• Stable medical condition

• Have been on a stable HAART regimen for > 6 months

• Have not had a change in medications that could potentially interfere with sleep or cognition in the past 4 months.

Exclusion Criteria:

• Berlin questionnaire score indicating high risk of obstructive sleep apnea

• Known history of sleep disorders (e.g., narcolepsy, hypersomnia, restless legs syndrome, REM-sleep behavior disorder) which currently require or previously required treatment

• Ongoing involvement in night shift work

• Not able to complete the 12 weeks of the sleep intervention due to a scheduling conflict

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV - Human Immunodeficiency Virus
• HIV Infections
• Immunologic Deficiency Syndromes
• Insomnia Disorder
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Digital cognitive behavioural therapy for insomnia (dCBT-I)
dCBT-I is a computer-based treatment intervention that provides strategies to improve sleep and daytime function (concentration, productivity) in individuals with insomnia

Locations

Country	Name	City	State
Canada	Montreal Neurological Institute and Hospital (McGill University)	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University	Sleepio

Country where clinical trial is conducted

Canada, 

References & Publications (24)

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Espie CA, Kyle SD, Hames P, Gardani M, Fleming L, Cape J. The Sleep Condition Indicator: a clinical screening tool to evaluate insomnia disorder. BMJ Open. 2014 Mar 18;4(3):e004183. doi: 10.1136/bmjopen-2013-004183. — View Citation

Espie CA, Kyle SD, Williams C, Ong JC, Douglas NJ, Hames P, Brown JS. A randomized, placebo-controlled trial of online cognitive behavioral therapy for chronic insomnia disorder delivered via an automated media-rich web application. Sleep. 2012 Jun 1;35(6):769-81. doi: 10.5665/sleep.1872. — View Citation

Espie CA, MacMahon KM, Kelly HL, Broomfield NM, Douglas NJ, Engleman HM, McKinstry B, Morin CM, Walker A, Wilson P. Randomized clinical effectiveness trial of nurse-administered small-group cognitive behavior therapy for persistent insomnia in general practice. Sleep. 2007 May;30(5):574-84. — View Citation

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Kyle SD, Miller CB, Rogers Z, Siriwardena AN, Macmahon KM, Espie CA. Sleep restriction therapy for insomnia is associated with reduced objective total sleep time, increased daytime somnolence, and objectively impaired vigilance: implications for the clinical management of insomnia disorder. Sleep. 2014 Feb 1;37(2):229-37. doi: 10.5665/sleep.3386. — View Citation

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Manber R, Edinger JD, Gress JL, San Pedro-Salcedo MG, Kuo TF, Kalista T. Cognitive behavioral therapy for insomnia enhances depression outcome in patients with comorbid major depressive disorder and insomnia. Sleep. 2008 Apr;31(4):489-95. — View Citation

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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. — View Citation

Savard J, Simard S, Ivers H, Morin CM. Randomized study on the efficacy of cognitive-behavioral therapy for insomnia secondary to breast cancer, part I: Sleep and psychological effects. J Clin Oncol. 2005 Sep 1;23(25):6083-96. — View Citation

Webel AR, Moore SM, Hanson JE, Patel SR, Schmotzer B, Salata RA. Improving sleep hygiene behavior in adults living with HIV/AIDS: a randomized control pilot study of the SystemCHANGE(TM)-HIV intervention. Appl Nurs Res. 2013 May;26(2):85-91. doi: 10.1016/j.apnr.2012.10.002. Epub 2012 Dec 21. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratio of total sleep time over time in bed	Obtained from the online self-reported sleep diaries aggregated over 7 days, completed at study entry and again at 12 weeks	12 weeks
Secondary	Insomnia Severity as assessed by the Insomnia Severity Index	Obtained from the online self-reported questionnaire completed at study entry and again at 12 weeks	12 weeks
Secondary	Cognitive performance as assessed by the Brief Cognitive Ability Measure (B-CAM)	Ruler-like measure of cognitive ability combining self-report and performance items	9 months
Secondary	Anxiety and Depression symptoms as assessed by the Hospital Anxiety Depression Scale	Questionnaire	9 months
Secondary	Quality of life as assessed by the WHO-QOL-HIV	Questionnaire	9 months
Secondary	Quality of life as assessed by the EQ-5D	Questionnaire	9 months