A Pilot Study of Digital Cognitive Behavioral Therapy for Veterans
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|ClinicalTrials.gov Identifier: NCT03688763|
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : May 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Insomnia||Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-i)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Digital Cognitive Behavioral Therapy for Veterans With Insomnia and Comorbid Psychopathology|
|Actual Study Start Date :||February 5, 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
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.
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).
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688763
|Contact: Shannon McCaslin-Rodrigo, Ph.D.||650/493-5000||Shannon.McCaslin@va.gov|
|United States, California|
|VA Palo Alto Health Care System||Recruiting|
|Palo Alto, California, United States, 94304|
|Contact: Diana L Villasenor 650-493-5000 ext 23827|