Recruiting

Insomnia Treatments

Sponsor:

VA Office of Research and Development

Code:

NCT05194930

Conditions

Insomnia

PTSD

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

The ABC of Insomnia (Acceptance and the Behavioral Changes to treat Insomnia)

Cognitive-Behavioral Therapy for Insomnia

Study Details

Brief summary:

This randomized trial will compare a novel treatment, Acceptance of the Behavioral Changes to Treat Insomnia (ABC-I) to Cognitive Behavioral Therapy for Insomnia (CBT-I) among Veterans with comorbid Post-Traumatic Stress Disorder (PTSD) and insomnia disorder. ABC-I combines the behavioral components of CBT-I with components of another behavioral therapy (Acceptance and Commitment Therapy) and has been shown to improve treatment adherence.

The study objectives are: 1) to evaluate the benefits of ABC-I in reducing post-traumatic stress disorder (PTSD) symptoms among Veterans with comorbid PTSD and insomnia disorder compared to CBT-I, and 2) to evaluate the effectiveness of ABC-I in improving insomnia symptoms and sleep quality among Veterans with comorbid PTSD and insomnia disorder as compared to CBT-I.

Veterans with insomnia and comorbid PTSD who receive care at Sepulveda and West Los Angeles facilities will be recruited for the study. Those who pass an initial eligibility screen will be enrolled and written informed consent will be obtained. A baseline assessment will be completed that includes measures of sleep, PTSD, and quality of life. Veterans who meet all eligibility criteria will be randomly assigned to the ABC-I (n=100) or CBT-I (n=100) treatment. Both treatments will be provided in 5 one-on-one sessions by a trained instructor who is supervised by a behavioral sleep medicine specialist. All randomized participants (n=200) will have 3 follow-up assessments (post-treatment, 3-months, and 6-months after randomization). The follow-up assessments will collect information on PTSD symptoms, insomnia symptoms and sleep quality.

Conditions

Insomnia

PTSD

Study ID

NCT05194930

Start date

Sep 1, 2022

Status verified date

Jul, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • community-dwelling Veterans aged 18 years and older,
  • received care from VAGLAHS in the prior year,
  • live within a 50-mile radius of the research offices at the VA Sepulveda Ambulatory Care Center,
  • have symptoms of PTSD,
  • have symptoms of insomnia.

Exclusion Criteria:

  • current pregnancy or has a child less than 6 months of age (men and women),
  • active substance users or in recovery with less than 90 days of sobriety,
  • too ill to engage in the study procedures,
  • unable to self-consent to participate,
  • unstable housing (since we may not be able to retrieve costly and difficult to replace monitoring equipment),
  • severe, untreated sleep disordered breathing (AHI>15 with excessive daytime sleepiness, or AHI>30),
  • restless legs syndrome that accounts for the sleep disturbances reported,
  • a circadian rhythm sleep disorder that accounts for the sleep disturbances reported (including shift work sleep disorder),
  • unstable medical or psychiatric disorders (which is a contraindication for behavioral treatment of insomnia);
  • remission of insomnia symptoms prior to randomization;
  • current participation in prolonged exposure therapy for PTSD.

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: The ABC of Insomnia (Acceptance and the Behavioral Changes to

This is the new treatment arm that is being compared to CBT-I, standard treatment for insomnia.

active comparator: Cognitive-Behavioral Therapy for Insomnia

This is the standard treatment for insomnia that is being compared to the new treatment (ABCI).

Interventions

The ABC of Insomnia (Acceptance and the Behavioral Changes to treat Insomnia)

5 individual sessions incorporating behavioral treatment components plus acceptance and commitment therapy (ACT) provided by a trained instructor.

Cognitive-Behavioral Therapy for Insomnia

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

Primary outcome measure

  • PTSD Check List for DSM-5 (PCL-5) [ Time Frame: 6-months follow-up ]
  • Insomnia Severity Index (ISI) [ Time Frame: 6-months follow-up ]
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 6-months follow-up ]
  • Sleep efficiency from 7-day sleep diary [ Time Frame: 6-months follow-up ]

Central Contacts and Locations

Central contacts

Jennifer L Martin, PhD

(305) 575-7000jennifer.martin@va.gov

Melyssa Sueiro

(305) 575-7000melyssa.sueiro@va.gov

Locations

VA Greater Los Angeles Healthcare System, Sepulveda, CA

Recruiting

Sepulveda, California, United States, 91343

Contacts

Gwendolyn Carlson, PhD

818-891-7711Gwendolyn.Carlson@va.gov

Diane I Lee, MSW

8188917711diane.lee@va.gov

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Keywords

  • Insomnia disorder
  • Chronic Post-Traumatic Stress Disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-07-27.