Internet-delivered CBT Intervention (Space for Sleep) for Insomnia: Pilot and Feasibility Study in a Routine Care Setting
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Changes in insomnia severity (as measured by the Insomnia Severity Index, ISI)
Study Overview
Brief Summary
The principal objective of the study is to assess the feasibility and preliminary efficacy of an online-delivered CBT-I intervention for those with insomnia or reporting sleep difficulties. The program will be offered to service users of IAPT to establish criteria for the planning of a future large scale RCT study.
Detailed Description
Meta-analytic evidence have shown that internet-delivered CBT-I works at improving insomnia severity, sleep efficiency, subjective sleep quality, wake after sleep onset, sleep onset latency, total sleep time, and number of nocturnal awakenings at post-treatment (Zachariae et al., 2016). Furthermore, these interventions have also been shown efficacious in decreasing depressive symptoms (Christensen et al., 2016).
However, no studies have explored the effects of internet-delivered CBT-I in routine care settings and all of them recruited a self-selected sample, which limits the generalizability of the results. In this sense, the present study is a first step to assess the feasibility and preliminary efficacy of internet-delivered CBT-I in a real-world setting: the Improving Access to Psychological Therapies (IAPT) program, National Health service, England.
The IAPT program is part of a stepped care model that principally addresses depression and anxiety in the population (Clark, 2011). It sees over a million users per year and delivers both low-intensity (e.g. internet-delivered CBT for depression and anxiety disorders; group wellbeing courses, bibliography) and high-intensity (e.g. counseling for depression, face-to-face CBT for depression and anxiety) services (Clark, 2011).
Within IAPT, SilverCloud Health as a global leader in the development and implementation of internet-delivered interventions for mental health, wellbeing and long-term condition management, has supported patients at a low-intensity level (i.e. Step 2) over the past 5 years. SilverCloud has recently developed an intervention for insomnia that will form part of the overall mental health care suite of programs that include interventions for depression and anxiety disorders. The outcomes of these online interventions have been equal to other low-intensity interventions used within IAPT. The current study seeks to pilot the newly developed CBT-I intervention to assess its initial clinical impact and to establish criteria for the planning of a future large scale RCT study.
Objective As part of service evaluation, patients at Berkshire NHS Foundation trust availed of the Space for Sleep program. The current study seeks to carry out research on the progress of these patients, assessing the program's initial clinical impact and to establish criteria for the planning of a future large scale RCT study.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •At least 18 years old
- •Reporting difficulty getting to sleep and/or staying asleep as their primary presentation
- •Suitability for an internet intervention (i.e. willingness to engage on the iCBT intervention, ability to read English, access internet, the capacity and willingness to consent)
- •No suicidal or self-harm risk and no specific communication needs.
Exclusion Criteria
- •Score above 0 on PHQ-9 question 9
- •Diagnosed psychotic illness
- •Currently on psychological or pharmacological treatment for sleep disorder
- •Alcohol or drug misuse
- •Previous diagnosis of an organic mental health disorder,
- •Have an unstable medication regimen.
Outcomes
Primary Outcomes
Changes in insomnia severity (as measured by the Insomnia Severity Index, ISI)
Time Frame: Baseline - Immediately after the intervention
The 7-item ISI (Yang, Morin, Schaefer, \& Wallenstein, 2009) provides a quantitative index of overall sleep impairment. Participants rate the severity of sleep problems (e.g. problems with sleep onset, sleep maintenance, and early morning awakening), interference with daytime functioning, how noticeable the impairment is to others, distress or concern caused by the sleep problem(s), as well as satisfaction with the current sleep pattern on a 5-point Likert scale. Scores range from 0-28, with higher scores indicating more severe insomnia. The ISI has been shown to be a valid and reliable measure that is sensitive to changes in treatment studies (Bastien, Vallières, \& Morin, 2001; Thorndike et al., 2011).
Changes in average sleep efficiency (i.e. total time spent asleep divided by the total time spent in bed in a given day)
Time Frame: Baseline - Immediately after the intervention
Sleep efficiency is the result of total time spent asleep divided by the total time spent in bed and multiplied by 100. Participants will be encouraged to complete a sleep diary which is available to them as a tool on the platform. They will be encouraged to complete this throughout treatment and will be prompted to do so upon their daily login. Data from the first and last week will be used as pre- and post-treatment measurements. Sleep efficiency of 85% or above is considered normal, with really good efficiency being 90% or above.
Secondary Outcomes
- Time spent in the platform(During the intervention)
- Acceptability of the modules(Immediately after each module of the intervention)
- Number of Activities(During the intervention)
- Number of Reviews(During the intervention)
- Number of sessions(During the intervention)
- Patient Health Questionnaire-9 (PHQ-9)(Baseline - Immediately after the intervention)
- Work and Social Adjustment Scale (WSAS)(Baseline - Immediately after the intervention)
- Generalized Anxiety Disorder-7 (GAD-7)(Baseline - Immediately after the intervention)
- Patient Experience Questionnaire (PEQ)(Immediately after the intervention)
- Percentage of the Program Viewed(During the intervention)