Internet-delivered CBT-I (Space for Sleep): Pilot and Feasibility
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

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.

      Specific research questions will be the following:

        -  Can Space for Sleep achieve positive clinical outcomes for patients?

        -  What are the levels of satisfaction and acceptance of users with the intervention?

        -  What are the levels of usage of the intervention?

      Design Moving from service evaluation to an open feasibility trial design to examine the
      potential clinical impact of an online CBT intervention for insomnia disorder (ID).

      Hypotheses SilverCloud online interventions for mental health have proved highly successful.
      The investigators anticipate that the current intervention for ID will show preliminary
      effectiveness at post-treatment in terms of greater sleep efficiency and significant
      reductions in symptoms of insomnia and co-morbid depression and anxiety.

      Study Setting The study will be conducted within Berkshire Healthcare NHS Foundation Trust
      through Talking Therapies, an NHS IAPT provider that serves a population of 900,000 across 7
      Clinical Commissioning Groups (CCGs), all of which are demographically and economically
      diverse, ranging from rural West Berkshire to urban commuter towns close to London. Talking
      Therapies aims to provide an easily accessible and clinically effective service for those
      within the community who suffer from sleep disorders. Those wishing to access the service can
      do so through self-referral, GP referral or referral from allied services. If suitable,
      clients are offered treatment either at Step 2 or Step 3 based on their need. Step 2 services
      include low-intensity CBT-based treatments such as self-help, iCBT and group treatment,
      supported by trained psychological wellbeing practitioners (PWP).

      Recruitment procedures The aim is to recruit 35 patients as part of service evaluation. A 50%
      uplift is added to buffer against the effects of dropout/missing data. Therefore, a total of
      52 participants will be included in the study. Patients who are already using the program as
      part of the service evaluation will be provided with an information sheet and asked if they
      wish to retrospective consent to for their data to be part of the research trial.

      For those who will be recruited into the research, firstly, individuals are given an initial
      assessment by phone with a PWP clinician at Berkshire IAPT service as per normal service
      provision. The assessment determines if an individual meets the eligibility criteria and a
      diagnosis of sleep disorder will be advised by the PWP. The PWP then describes the trial and
      invites the client to participate. Those interested will receive an email with information
      detailing the study and a link to the consent form to give consent by means of a digital
      signature. Upon giving consent, participants complete the primary and secondary outcomes for
      the study online. PWPs will reiterate details of the research and the program, describing
      what is involved and the importance of their participation in the trial. Participants receive
      an email informing them on how to proceed.

      All participants are informed that they are free to withdraw if they no longer wish to take
      part in the trial. In this case, they will be removed from the trial and they will be offered
      treatment as usual.

      Support during treatment Each participant will be assigned a PWP clinician who will monitor
      participants' progress throughout the trial. Once assigned to the active treatment condition
      the participant will receive a message from their PWP clinician at their first login. This
      message welcomes them to the program, highlights aspects of the program, and encourages them
      in use of the program. Over the course of the 8-week supported intervention, on 6 separate
      occasions the PWP will login and review participants progress, leaving feedback for them and
      responding to the work they have completed. The basic share level allows supporters to view
      users' goals for the week; key messages and progress points. If users wish to share more with
      their supporter, they can share journal entries. Each supporter will provide post-session
      feedback of between 10 and 15 minutes per participant per session, over the eight-week
      intervention period.
    

Intervention name(s): SilverCloud
Intervention type(s): Behavioral
Intervention description(s): 'Space for Sleep' is a seven-module online CBT-based intervention for sleep. The structure and content of the programme modules follow evidence-based CBT principles for insomnia. Each module is structured to incorporate introductory quizzes. videos, informational content, interactive activities, as well as homework suggestions and summaries. In addition, personal stories and accounts from other users are incorporated into the presentation of the material.
As per normal service provision, each participant will be assigned a clinician (PWP) who will monitor participants' progress through the program. Every one to two weeks, the PWP will login and review participants' progress, leaving feedback for them and responding to the work they have completed.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: insomnia; online interventions; CBT; IAPT; depression