Testing the Insomnia Coach Mobile App With Veterans With Insomnia and PTSD

NCT07083869 | Not Yet Recruiting

• 1 other identifier: IRB-79382
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this randomized controlled trial of the Insomnia Coach mobile app is to evaluate the potential effects of app use on reducing insomnia symptoms among Veterans with significant insomnia and PTSD symptoms. It is also intended to evaluate the impact of the app on other outcomes, including PTSD, depression, and anxiety symptoms, and psychosocial functioning. Finally, the study is designed to assess perceptions of Insomnia Coach regarding its perceived helpfulness, satisfaction, and likes/dislikes to inform its continued improvement. The results of this study will inform the next steps of research evaluating Insomnia Coach with Veterans with significant insomnia and PTSD symptoms, namely a larger-scale, VA ORD or NIH funded randomized controlled trial.

Conditions

Insomnia; Posttraumatic Stress Disorder (PTSD)

Keywords

Mobile app; Veteran; Cognitive Behavioral Therapy for Insomnia

Outcome Measures

Primary Outcomes (3)

• Insomnia Severity Index (ISI; Bastien et al., 2011)

  A 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia symptoms in the past month. Items are on a scale from 0 to 4. The seven answers are added up to get a total score, with higher scores reflecting greater insomnia severity

  8 and 16 weeks

• Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989)

  A 19-item self-report measure assessing qualities and problems associated with sleep in the past month. It generates seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. A global sleep quality score is obtained by summing the seven component scores. Higher scores reflect poorer sleep quality. The global score ranges from 0 to 21, with a cut-off score of 5 as distinguishing "good" sleepers from "poor" sleepers.

  8 and 16 weeks

• PROMIS-Sleep-Related Impairment (PROMIS-SRI; Buysse et al., 2010)

  This 16-item self-report form assesses sleep-related impairment over the past seven days. Each question has five response options ranging in value from 1 to 5. To find the total raw score the values of the response to each question are summed. The raw scores are converted to a standardized T-score using conversion tables published on the PROMIS website (nihpromis.org), with higher scores indicating greater sleep/wake disturbances.

  8 and 16 weeks

Secondary Outcomes (9)

• Generalized Anxiety Disorder - 7 Item (GAD-7; Spitzer et al., 2006)

  8 and 12 weeks

• Patient Health Questionnaire 8 (PHQ-8; Kroenke et al., 2009)

  8 and 16 weeks

• Mobile Apps Rating Scale (MARS; Stoyanov et al., 2015)

  8 weeks

• System Usability Scale (SUS; Brooke, 1986)

  8 weeks

• Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16; Morin et al., 2007).

  8 and 12 weeks

Study Arms (2)

Insomnia Coach Mobile App

EXPERIMENTAL

Insomnia Coach is a mobile application that provides psychoeducation and self-management tools for insomnia symptoms based on cognitive behavioral therapy for insomnia (CBT-I).

Behavioral: Insomnia Coach

Sleep Well Website

ACTIVE COMPARATOR

Sleep Well is a website that is mobile enabled that provides psychoeducation about healthy sleep habits that is based on NIH Health Guide to Health Sleep and VA's Whole Health Change Your Habits to Sleep Better.

Behavioral: Sleep Well

Interventions

Insomnia Coach BEHAVIORAL

Insomnia Coach is a mobile application that provides psychoeducation and self-management tools for insomnia symptoms based on cognitive behavioral therapy for insomnia (CBT-I)

Insomnia Coach Mobile App

Sleep Well BEHAVIORAL

Sleep Well is a website that is mobile enabled that provides psychoeducation about healthy sleep habits that is based on NIH Health Guide to Health Sleep and VA's Whole Health Change Your Habits to Sleep Better.

Sleep Well Website

Eligibility Criteria

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

You may qualify if:

• U.S. military Veteran
• Aged 18 years or older
• Owner of smartphone or tablet with Android or iOS operating system
• Probable insomnia (i.e., ISI \>=15)
• Probable PTSD (i.e., PCL-5 \>=31)
• Able to read/write English
• Internet connection and active email address

You may not qualify if:

• Comorbid sleep disorders (apnea, RLS, narcolepsy)\*
• Started or changed dosage of sleep medications or SSRIs in past 2 months
• Unstable housing
• Medical condition identifiably causing sleep problems
• Current mania or psychosis or seizure-related disorder
• Currently receiving or having recently received insomnia therapy resembling CBT-I
• Shift working
• Pregnant
• Newborn (3 mos. or younger) living in residence

Sponsors & Collaborators

• VA Palo Alto Health Care System: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Central Study Contacts

Eric R. Kuhn, Ph.D.

CONTACT

650-493-5000; eric.kuhn@va.gov

Joseph Wielgosz, Ph.D.

CONTACT

650-498-4538; joseph.wielgosz@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 24, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share