N/A N=149 Randomized Double-blind Treatment

Insomnia Treatment for Women Veterans

Insomnia

Bottom Line

View on ClinicalTrials.gov: NCT02076165 ↗

Enrolled (actual)

149

Serious AEs

0.0%

Results posted

May 2019

Primary outcome: Primary: Number of Participants Completing 5 Behavioral Treatment Sessions — 63; 70 Participants — p==.120

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Acceptance and the Behavioral Changes to Treat Insomnia (Behavioral); Cognitive behavioral therapy for insomnia (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: VA Office of Research and Development
Primary completion: Feb 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Completing 5 Behavioral Treatment Sessions	63; 70	=.120
PRIMARY Adherence With Bedtime Recommendations	-6.43; -5.71	=.843
PRIMARY Adherence to Rise Time Recommendations	20.63; 23.41	=0.590
PRIMARY Non-adherence to Nighttime Stimulus Control	.274; .273	=0.979
SECONDARY Sleep Efficiency From Sleep Diary at Post-Treatment	13.88; 13.47	=0.004 sig
SECONDARY Sleep Efficiency From Sleep Diary at 3-month Follow-up	12.74; 11.98	.003 sig
SECONDARY Sleep Efficiency From Actigraphy at Post-Treatment	2.32; 1.64	<0.001 sig
SECONDARY Sleep Efficiency From Wrist Actigraphy at 3-month Follow-up	1.33; 0.22	<.001 sig
SECONDARY Change From Baseline to Post-Treatment in Insomnia Severity Index Score	-8.68; -9.18	=0.048 sig
SECONDARY Change From Baseline to 3-month Follow-up in Insomnia Severity Index Score	-8.29; -7.71	=0.008 sig

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.

Eligibility Criteria

Inclusion Criteria

Female Veteran
Community-dwelling
Age 18 years and older
Received care from VA Greater Los Angeles Healthcare System in the past six months
Responses to postal survey indicate symptoms of insomnia
Did not check "opt-out" box for further contact on postal survey
Live within 50 mile radius of Sepulveda VA Ambulatory Care Center

Exclusion Criteria

Unstable housing
No transportation to the medical center
Current pregnancy
Significant health or emotional problems, or use of drugs or alcohol
Untreated sleep apnea
Restless legs syndrome that accounts for the sleep disturbances reported
Circadian rhythm sleep disorder that accounts for the sleep disturbances reported
Active substance users or in recovery with less than 90 days of sobriety
Unstable medical or psychiatric disorders (which is a contraindication for behavioral treatment of insomnia)
Remission of insomnia

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02076165). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.