Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Pilot Study of Digital Cognitive Behavioral Therapy for Veterans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03688763
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : May 6, 2020
Sponsor:
Collaborator:
Big Health
Information provided by (Responsible Party):
Shannon McCaslin, Palo Alto Veterans Institute for Research

Tracking Information
First Submitted Date  ICMJE April 3, 2018
First Posted Date  ICMJE September 28, 2018
Last Update Posted Date May 6, 2020
Actual Study Start Date  ICMJE February 5, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2020)
  • Changes in the Insomnia Severity Index (ISI) [ Time Frame: 0 weeks (baseline), 12 weeks (end of Intervention Phase), and 16 weeks (Follow-Up) ]
    The ISI is used to assess self-reported insomnia severity (Bastien et al., 2001). It is a 7-item self-report scale assessing sleep problem severity over the last two weeks, rated on a 5-point scale from 0 to 4; a higher score indicates higher severity. The ISI sums scores on the 7 items (1a, 1b, 1c, 2, 3, 4, 5) for a total score range of 0 to 28.
  • Changes in Consensus Sleep Diary (CSD) [ Time Frame: 12 weeks (end of Intervention Phase) and 16 weeks (Follow-Up) ]
    The CSD (Carney et al., 2012) will be used to monitor self-reported sleep during the baseline phase, over the course of the digitally administered CBT-I intervention, and throughout follow-up. The CSD is a standardized sleep diary based on expert consensus and qualitative patient input.
  • Changes in Participant Perception of the Acceptability, Perceived Value, and Feasibility of using a Digital Modality to Treat Insomnia Symptoms [ Time Frame: 12 weeks (end of Intervention Phase) and 16 weeks (Follow-Up) ]
    This unpublished measure requests information on the participants impressions of using digitally administered CBT-i. Questions ask about the following areas: 1) Use of the digitally administered intervention including general impressions and frequency of use, 2) Perceived value and helpfulness of the digitally administered intervention including which features of the program were perceived to be most useful and how the program impacted different aspects of insomnia and management of insomnia, 3) Impact on health (e.g., perceived impact on management of insomnia), 4) Potential enhancements (i.e. recommendations for improvements to the intervention).
Original Primary Outcome Measures  ICMJE
 (submitted: September 26, 2018)
  • Changes in the Insomnia Severity Index (ISI) [ Time Frame: Baseline (Week 1 - Week 6); 1 and 3 months following completion of the intervention ]
    The ISI is used to assess self-reported insomnia severity (Bastien et al., 2001). It is a 7-item self-report scale assessing sleep problem severity over the last two weeks, rated on a 5-point scale from 0 to 4; a higher score indicates higher severity. The ISI sums scores on the 7 items (1a, 1b, 1c, 2, 3, 4, 5) for a total score range of 0 to 28.
  • Changes in Consensus Sleep Diary (CSD) [ Time Frame: Baseline (Week 1 - Week 6); 1 and 3 months following completion of the intervention ]
    The CSD (Carney et al., 2012) will be used to monitor self-reported sleep during the baseline phase, over the course of the digitally administered CBT-I intervention, and throughout follow-up. The CSD is a standardized sleep diary based on expert consensus and qualitative patient input.
  • Changes in Participant Perception of the Acceptability, Perceived Value, and Feasibility of using a Digital Modality to Treat Insomnia Symptoms [ Time Frame: 1 and 3 months following completion of the intervention ]
    This unpublished measure requests information on the participants impressions of using digitally administered CBti. Questions ask about the following areas: 1) use of the digitally administered intervention including general impressions and frequency of use, 2) Perceived value and helpfulness of the digitally administered intervention including which features of the program were perceived to be most useful and how the program impacted different aspects of insomnia and management of insomnia, 3) Impact on health (e.g., perceived impact on management of insomnia), 4) Potential enhancements (i.e. recommendations for improvements to the intervention).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2020)
  • Changes in The Posttraumatic Checklist-5 (PCL-5) [ Time Frame: 0 weeks (baseline), 12 weeks (end of Intervention Phase), and 16 weeks (Follow-Up) ]
    The PCL-5 is a self-report measure of PTSD symptom severity (Weathers et al., 2013). The PCL is a 20-item measure which asks respondents how much they had been bothered in the prior month by their most traumatic experience. Item responses range from 0 (not very much) to 4 (extremely) with a total score range is 0-80. DSM-5 symptom cluster scores sum item scores: Cluster B (items 1-5), C (6-7), D (8-14), and E (items 15-20).
  • Changes in The Patient Health Questionnaire: Depression Scale (PHQ-9) [ Time Frame: 0 weeks (baseline), 12 weeks (end of Intervention Phase), and 16 weeks (Follow-Up) ]
    The PHQ-9 is a 9-item self-report scale assessing depression over the last two weeks (Kroenke et al., 2002). An additional item asking about global depression and interference with life activities is not included in the PHQ-9 score. Items are scored from 0 (not at all) to 3 (nearly every day), for a total score range of 0 to 27.
  • Changes in the Generalized Anxiety Disorder 7-Item Scale (GAD-7) [ Time Frame: 0 weeks (baseline), 12 weeks (end of Intervention Phase), and 16 weeks (Follow-Up) ]
    The GAD-7 is a 7-item anxiety scale (Spitzer et al., 2006) assessing symptoms over the past two weeks. Item scores range from 0 (not at all) to 3 (nearly every day). Items are summed to yield a total score.
  • Changes in The Brief Inventory for Psychosocial Functioning (B-IPF) [ Time Frame: 0 weeks (baseline), 12 weeks (end of Intervention Phase), and 16 weeks (Follow-Up) ]
    The B-IPF-7 is a 7-item measure scored from 0 (not at all) to 6 (very much) (Bovin et al., 2018). The total score is the mean of the sum of all 7 items. The B-IPF assesses social functioning, academic and occupational functioning, daily activities over the past 30 days.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2018)
  • Changes in The Posttraumatic Checklist-5 (PCL-5) [ Time Frame: Baseline (Week 1 - Week 6); 1 and 3 months following completion of the intervention ]
    The PCL-5 is a self-report measure of PTSD symptom severity (Weathers et al., 2013). The PCL is a 20-item measure which asks respondents how much they had been bothered in the prior month by their most traumatic experience. Item responses range from 0 (not very much) to 4 (extremely) with a total score range is 0-80. DSM-5 symptom cluster scores sum item scores: Cluster B (items 1-5), C (6-7), D (8-14), and E (items 15-20).
  • Changes in The Patient Health Questionnaire: Depression Scale (PHQ-9) [ Time Frame: Baseline (Week 1 - Week 6); 1 and 3 months following completion of the intervention ]
    The PHQ-9 is a 9-item self-report scale assessing depression over the last two weeks (Kroenke et al., 2002). An additional item asking about global depression and interference with life activities is not included in the PHQ-9 score. Items are scored from 0 (not at all) to 3 (nearly every day), for a total score range of 0 to 27.
  • Changes in the Generalized Anxiety Disorder 7-Item Scale (GAD-7) [ Time Frame: Baseline (Week 1 - Week 6); 1 and 3 months following completion of the intervention ]
    The GAD-7 is a 7-item anxiety scale (Spitzer et al., 2006) assessing symptoms over the past two weeks. Item scores range from 0 (not at all) to 3 (nearly every day). Items are summed to yield a total score.
  • Changes in The Brief Inventory for Psychosocial Functioning (B-IPF) [ Time Frame: Baseline (Week 1 - Week 6); 1 and 3 months following completion of the intervention ]
    The B-IPF-7 is a 7-item measure scored from 0 (not at all) to 6 (very much) (Bovin et al., 2018). The total score is the mean of the sum of all 7 items. The B-IPF assesses social functioning, academic and occupational functioning, daily activities over the past 30 days.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study of Digital Cognitive Behavioral Therapy for Veterans
Official Title  ICMJE A Pilot Study of Digital Cognitive Behavioral Therapy for Veterans With Insomnia and Comorbid Psychopathology
Brief Summary The proposed study is a multiple baseline design pilot study which seeks to evaluate the impact of digitally administered CBT-I, using the Sleepio platform, for the treatment of insomnia disorder among Veterans with co-morbid psychopathology. In addition, information related to acceptability and feasibility of the intervention among a Veteran sample will be obtained.
Detailed Description Cognitive Behavioral Therapy for Insomnia (CBT-I) is considered the front-line intervention for individuals with insomnia and has recently been rolled-out throughout the Veterans Health Administration (VHA; Manber et al., 2012). CBT-I includes behavioral (sleep restriction, stimulus control, relaxation exercises), cognitive (cognitive restructuring, mindfulness exercise), and psychoeducation (sleep hygiene) components. While CBT-I has been demonstrated to be a highly efficacious and effective intervention, it is a specialized intervention that can be costly and is in limited supply based on the level of training required and number of providers available. For this reason, digital administration of CBT-I has been examined and research has demonstrated initial efficacy among community samples (Ritterband et al., 2009; Vincent et al., 2009; Espie et al., 2012), with one platform, Sleepio, demonstrating efficacy compared to a placebo intervention (Espie et al., 2012; Espie et al., 2014). For this reason, the current study will utilize the Sleepio platform which provides an interactive, customized and tailored delivery of CBT-I.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Insomnia
Intervention  ICMJE Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-i)
CBT-i is an evidence-based treatment for insomnia. Participants will receive CBT-i via online program (Sleepio).
Study Arms  ICMJE Digital CBTi administered
Participants will receive 6 sessions of digitally administered CBTi using the Sleepio platform over the course of 12 weeks. Each session lasts on average 30-60 minutes, and is tailored to participant's progress and problems. During the treatment phase, between sessions, participants complete the Consensus Sleep Diary to track their progress.
Intervention: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-i)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 4, 2020)
10
Original Estimated Enrollment  ICMJE
 (submitted: September 26, 2018)
15
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Participants must be:

  • at least 18 years of age (no upper age limit)
  • meet DSM-5 defined criteria for insomnia disorder
  • be on a stable dose of any prescription medication (including sleep medication) for at least 2 weeks prior to the in-person screening assessment
  • have comorbid psychopathology (i.e., symptoms of Posttraumatic Stress Disorder (PTSD), anxiety, and/or depression)

Exclusion Criteria:

  • limited mental competency (not oriented to person, place, or time) and the inability to give informed, voluntary, or written consent to participate
  • high risk for sleep apnea (STOP-Bang score >/= 3)
  • current or previous diagnosis of sleep apnea that is untreated
  • history of moderate or severe Traumatic Brain Injury
  • current substance or alcohol use disorder, moderate to severe, in the past 3 months
  • current bipolar disorder
  • current or lifetime psychotic disorders
  • seizure disorders
  • moderate to high risk of suicide in the past month
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shannon McCaslin-Rodrigo, Ph.D. 650/493-5000 Shannon.McCaslin@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03688763
Other Study ID Numbers  ICMJE MCC0002ARG
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Shannon McCaslin, Palo Alto Veterans Institute for Research
Study Sponsor  ICMJE Palo Alto Veterans Institute for Research
Collaborators  ICMJE Big Health
Investigators  ICMJE Not Provided
PRS Account Palo Alto Veterans Institute for Research
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP