About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Insomnia Coach
BehavioralInsomnia Coach is a mobile application that provides psychoeducation and self-management tools for insomnia symptoms based on cognitive behavioral therapy for insomnia (CBT-I)
Sleep Well
BehavioralSleep 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.
Treatment groups
Trial outcomes
Primary outcomes
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
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.
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.
Secondary outcomes
Generalized Anxiety Disorder - 7 Item (GAD-7; Spitzer et al., 2006)
This 7-item measure assesses anxiety symptom severity. Items are scored from zero to three. The whole scale score can range from 0 to 21 and cut-off scores for mild, moderate and severe anxiety symptoms are 5, 10 and 15 respectively.
Patient Health Questionnaire 8 (PHQ-8; Kroenke et al., 2009)
An 8-item self-report instrument used to assess depression severity. Since the scale is self-administered in our studies and further probing about positive responses is not feasible, the question about suicide from the PHQ-9 was removed. Items are scored 0 to 3, with the total score being the sum of the 8 items. Higher scores indicate greater depression severity, with a score of 10 or greater considered major depression, and scores of 20 or more is severe major depression.
Mobile Apps Rating Scale (MARS; Stoyanov et al., 2015)
A 20-item multidimensional, objective measure of app usability. It includes four subscales that measure an app's engagement, functionality, aesthetics, and information quality. All items are rated on a 5-point scale from "1. Inadequate" to "5. Excellent". The scores are tallied up and a mean score out of 5 is given to each of the categories scored.
System Usability Scale (SUS; Brooke, 1986)
A 10-item questionnaire of usability of products and services, including hardware, software, mobile devices, websites and applications. Items are on a 5-point scale numbered 1 to 5. Half of the items are worded negatively and half are worded positively. SUS yields a single number representing a composite measure of the overall usability of the system. To calculate the SUS score, the score contributions from each item are summed. Each item's score contribution will range from 0 to 4. For items 1,3,5,7,and 9 the score contribution is the scale position minus 1. For items 2,4,6,8 and 10, the contribution is 5 minus the scale position. Then the sum of the scores is multiplied by 2.5 to obtain the overall value of SU. SUS scores have a range of 0 to 100.
Locations
Sponsors and contacts
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