Internet-delivered CBT-I (Space for Sleep): Pilot and Feasibility

NCT04493593 | Completed DMC

• 1 other identifier: Sleep_IAPT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Keywords

insomnia; online interventions; CBT; IAPT; depression

Outcome Measures

Primary Outcomes (2)

• Changes in insomnia severity (as measured by the Insomnia Severity Index, ISI)

  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).

  Baseline - Immediately after the intervention

• Changes in average sleep efficiency (i.e. total time spent asleep divided by the total time spent in bed in a given day)

  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.

  Baseline - Immediately after the intervention

Secondary Outcomes (10)

• Patient Health Questionnaire-9 (PHQ-9)

  Baseline - Immediately after the intervention

• Generalized Anxiety Disorder-7 (GAD-7)

  Baseline - Immediately after the intervention

• Work and Social Adjustment Scale (WSAS)

  Baseline - Immediately after the intervention

• Patient Experience Questionnaire (PEQ)

  Immediately after the intervention

• Acceptability of the modules

  Immediately after each module of the intervention

Study Arms (1)

Space for Sleep Group

EXPERIMENTAL

SilverCloud internet-delivered CBT intervention for Insomnia

Behavioral: SilverCloud

Interventions

SilverCloud BEHAVIORAL

'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.

Space for Sleep Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Silver Cloud Health: lead
• Berkshire Healthcare NHS Foundation Trust: collaborator
• University of Dublin, Trinity College: collaborator

Study Sites (1)

Berkshire NHS Foundation Trust

Bracknell, RG12 1LD, United Kingdom

Location

Related Publications (12)

• Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.

  PMID: 11438246 BACKGROUND

• Christensen H, Batterham PJ, Gosling JA, Ritterband LM, Griffiths KM, Thorndike FP, Glozier N, O'Dea B, Hickie IB, Mackinnon AJ. Effectiveness of an online insomnia program (SHUTi) for prevention of depressive episodes (the GoodNight Study): a randomised controlled trial. Lancet Psychiatry. 2016 Apr;3(4):333-41. doi: 10.1016/S2215-0366(15)00536-2. Epub 2016 Jan 28.

  PMID: 26827250 BACKGROUND

• Clark DM. Implementing NICE guidelines for the psychological treatment of depression and anxiety disorders: the IAPT experience. Int Rev Psychiatry. 2011 Aug;23(4):318-27. doi: 10.3109/09540261.2011.606803.

  PMID: 22026487 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.

  PMID: 11983645 BACKGROUND

• Richards DA, Suckling R. Improving access to psychological therapies: phase IV prospective cohort study. Br J Clin Psychol. 2009 Nov;48(Pt 4):377-96. doi: 10.1348/014466509X405178. Epub 2009 Feb 9.

  PMID: 19208291 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. doi: 10.1001/jama.282.18.1737.

  PMID: 10568646 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• Thorndike FP, Ritterband LM, Saylor DK, Magee JC, Gonder-Frederick LA, Morin CM. Validation of the insomnia severity index as a web-based measure. Behav Sleep Med. 2011;9(4):216-23. doi: 10.1080/15402002.2011.606766.

  PMID: 22003975 BACKGROUND

• Yang M, Morin CM, Schaefer K, Wallenstein GV. Interpreting score differences in the Insomnia Severity Index: using health-related outcomes to define the minimally important difference. Curr Med Res Opin. 2009 Oct;25(10):2487-94. doi: 10.1185/03007990903167415.

  PMID: 19689221 BACKGROUND

• Zachariae R, Lyby MS, Ritterband LM, O'Toole MS. Efficacy of internet-delivered cognitive-behavioral therapy for insomnia - A systematic review and meta-analysis of randomized controlled trials. Sleep Med Rev. 2016 Dec;30:1-10. doi: 10.1016/j.smrv.2015.10.004. Epub 2015 Oct 24.

  PMID: 26615572 BACKGROUND

• Zahra D, Qureshi A, Henley W, Taylor R, Quinn C, Pooler J, Hardy G, Newbold A, Byng R. The work and social adjustment scale: reliability, sensitivity and value. Int J Psychiatry Clin Pract. 2014 Jun;18(2):131-8. doi: 10.3109/13651501.2014.894072. Epub 2014 Mar 16.

  PMID: 24527886 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Depression

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Derek Richards

  SilverCloud Health

  STUDY DIRECTOR

• Sarah Sollesse

  Berkshire NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 30, 2020
• Study Start: September 5, 2019
• Primary Completion: June 21, 2020
• Study Completion: June 21, 2020
• Last Updated: January 29, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)