Treatments for Insomnia in Veterans With PTSD

Insomnia Clinical Trial

Official title:

A Novel Acceptance-based Treatment for Insomnia in Veterans With Post-Traumatic Stress Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05194930
• Other study ID #: IIR 20-283
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: January 31, 2026

Study information

• Verified date: August 2023
• Source: VA Office of Research and Development
• Contact: Jennifer L Martin, PhD
• Phone: (818) 891-7711
• Email: jennifer.martin[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Poor sleep is a nearly universal experience after trauma and in the context of PTSD non-pharmacological therapies are considered first-line treatments, yet VA/DoD clinical practice guidelines acknowledged the paucity of available evidence on the treatment of insomnia disorder in the context of PTSD. There is evidence of sleep-related benefits with CBT-I for individuals with insomnia and psychiatric comorbidities, but challenges remain. Insomnia treatments studied among Veterans with PTSD have typically been combined treatments to address both conditions. While promising, these treatments are difficult to implement because of their length and complexity. Furthermore, studies generally have not compared novel sleep-focused treatments to CBT-I (i.e., standard care for insomnia), making it difficult to support a change in the allocation of clinical resources to train providers in new sleep-focused interventions.

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 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. The analytic plan will simultaneously address superiority of ABC-I over CBT-I for improving PTSD symptoms and non-inferiority of ABC-I compared to CBT-I for improving insomnia symptoms.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: January 31, 2026
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia
• PTSD
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	VA Greater Los Angeles Healthcare System, Sepulveda, CA	Sepulveda	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Carlson GC, Kelly MR, Mitchell M, Josephson KR, McGowan SK, Culver NC, Kay M, Alessi CA, Fung CH, Washington DL, Hamilton A, Yano EM, Martin JL. Benefits of Cognitive Behavioral Therapy for Insomnia for Women Veterans with and without Probable Post-Trauma — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD Check List for DSM-5 (PCL-5)	The PCL-5 total score will be the main outcome measure for PTSD symptom severity. The PCL-5 is a standardized assessment for PTSD, based on DSM-5. The 20-item scale assesses the presence and severity PTSD symptoms on a 0-4 Likert scale, with a total symptom severity score range from 0-80. A score greater than or equal to 33 is indicative of probable PTSD.	6-months follow-up
Primary	Insomnia Severity Index (ISI)	Mean score on Insomnia Severity Index (ISI). This 7-item scale measures self-reported severity of insomnia symptoms.; Total score ranges from 0 to 28, with higher scores indicating greater insomnia severity.	6-months follow-up
Primary	Pittsburgh Sleep Quality Index (PSQI)	Mean PSQI score will be used as a measure of sleep quality. Scores range from 0 to 21. Higher scores indicate worse sleep quality.	6-months follow-up
Primary	Sleep efficiency from 7-day sleep diary	Sleep efficiency (mean percent time asleep while in bed) will be calculated from 7 days of self-reported sleep diary.; Scores range from 0 to 100 percent. Higher scores indicate better outcome.	6-months follow-up