Insomnia Disorder Clinical Trial
Official title:
Efficacy Potential of an Internet-based Sleep Program to Improve Sleep Quality in People With HIV
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.
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.
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