CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 347 enrolled
Drug / intervention
Acceptance and the Behavioral Changes to Treat Insomnia +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02076165
NCT02076165N/ACompleted

A Patient-Focused Approach to Insomnia Treatment for Women Veterans

VA Office of Research and Development·interventional·Posted Mar 3, 2014·Updated Jun 11, 2019

In Brief

A clinical study evaluating Acceptance and the Behavioral Changes to Treat Insomnia and Cognitive behavioral therapy for insomnia for Insomnia. Completed, enrolled 347 participants across 1 site.

Detailed Summary

Women Veterans have high rates of insomnia. Prior research and our preliminary findings show that insomnia impacts the health and quality of life of women Veterans and that those with insomnia prefer non-medication treatments over sleeping pills. This study compared two non-medication behavioral treatments for insomnia to determine impacts on adherence rates and sleep/wake patterns. A novel treatment, Acceptance and the Behavioral Changes to Treat Insomnia (ABC-I) was compared to standard treatment, Cognitive Behavioral Therapy for Insomnia (CBT-I). The results showed that ABC-I was non-inferior to CBT-I and adherence to the treatments was similar in both groups. These results improve the repertoire of available behavioral treatments for insomnia within VA by showing that a new treatment, called ABC-I, works as well as standard CBT-I.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 3, 2014
Enrollment StartSep 1, 2014
Primary CompletionFeb 28, 2018
Study CompletionAug 31, 2018
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 12.3 years ago

Interventions

Acceptance and the Behavioral Changes to Treat Insomniabehavioral

Participants attended 5 individual sessions incorporating behavioral treatment components plus acceptance and commitment therapy (ACT) with a trained instructor.

Cognitive behavioral therapy for insomniabehavioral

Participants attended 5 individual sessions incorporating behavioral and cognitive therapy components with a trained instructor.