Integrated CBT-I and PE on Sleep and PTSD Outcomes (Impact Study)

NCT02774642 | Completed Results

• 2 other identifiers: D2120-W1lK2Rx002120-01
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to examine whether integrating insomnia and PTSD treatment will enhance sleep, PTSD, and quality of life outcomes. This is a randomized control trial comparing integrated evidence based CBT-I into PE (CBTI-PE) versus to a non-active sleep component plus PE (hygiene-PE) to optimize PTSD, sleep, and quality of life outcomes in 90 Veterans. Such benefits would further the VA's commitment to improving the mental health, recovery, and community reintegration of Veterans detailed in the 2014-2020 VHA Strategic Plan. Findings from the proposed study offer a unique opportunity to determine the malleability of mechanisms (e.g., Total sleep time, Sleep efficiency) that can improve recovery outcomes among this vulnerable population and to inform future treatment development and research. Improved PTSD, insomnia, and quality of life outcomes can decrease risk of chronic impairment and ultimately help affected Veterans live richer, more productive lives.

Conditions

Posttraumatic Stress Disorders; Chronic Insomnia

Keywords

PTSD; insomnia; CBT-I; Prolonged Exposure; Veteran

Outcome Measures

Primary Outcomes (2)

• Change in PTSD Symptoms

  PTSD Symptoms will be assessed using the Clinician-Administered PTSD Scale DSM 5 (CAPS-5). Range (0 - 80). Lower scores equate to lower PTSD severity. Change in PTSD will be assessed longitudinally using linear mixed effects models of the CAPS-5 at each timepoint to estimate slope (change) over time.

  Baseline, Post Treatment (14-weeks), Follow-up (26-weeks)

• Change in Sleep Efficiency

  Change in sleep efficiency. Sleep efficiency is calculated from two variables acquired from daily sleep logs filled out by patient: a) time spend in bed and b) time spent asleep. Sleep efficiency = time spent asleep / time spent in bed. Range (0 -100%). Higher sleep efficiency is better. Change in Sleep Efficiency will be assessed longitudinally using linear mixed effects models of measure at each timepoint to estimate slope (change) over time.

  Baseline, Post Treatment (14-weeks), Follow-up (26-weeks)

Secondary Outcomes (2)

• Change in Quality of Life

  Baseline, Post Treatment (14-weeks), Follow-up (26-weeks)

• Change in Insomnia Severity

  Baseline, week 5, Post Treatment (14-weeks), Follow-up (26-weeks)

Other Outcomes (2)

• The Client Satisfaction Questionnaire (CSQ)

  Post Treatment ( up to 14-weeks)

• Brief Pain Inventory

  post treatment, and 3-month follow-ups presented.

Study Arms (2)

CBTI-PE

EXPERIMENTAL

Integrates the core components of CBT-I and PE in 14 90-minute weekly sessions.

Behavioral: CBTI-PE

Hygiene-PE

ACTIVE COMPARATOR

Uses non-active sleep hygiene to account for the dose response of experimental condition before starting PE. Uses 14 90-minute weekly sessions.

Behavioral: Hygiene-PE

Interventions

CBTI-PE BEHAVIORAL

Integrates CBT-I and PE with the goal of enhancing both insomnia and PTSD outcomes. Integrated treatment will be delivered in 14 90-minute weekly sessions. CBTI-PE starts with VA rollout CBT-I for the first 3 weeks with a focus on the effects of PTSD on insomnia. PE protocol (psychoeducation) begins on week 4 of treatment and both treatments overlap till week 6 when CBT-I ends and the active treatment of PE begins (i.e., imaginal and in-vivo exposures). However, CBT-I sleep diary review and sleep time adjustment will continue till the end of treatment to increase adherence

CBTI-PE

Hygiene-PE BEHAVIORAL

The investigators have included a non-active sleep control arm (3 Sessions)to allow for the dose response of 14 90 minute sessions. The non-active sleep control condition used in this study is a manualized protocol developed to exclude the active components of standard CBT-I treatment. Hygiene includes presentation of sleep hygiene education and reviewing daily stressors that may impact sleep before starting PE on week 4.

Hygiene-PE

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over the age of 19 years old
• Diagnosis of PTSD
• Meet diagnostic criteria for insomnia
• Enrolled at the VA San Diego Healthcare System (VASDHS) and living within 50 miles of the respective facility
• English literacy

You may not qualify if:

• Unmanaged psychosis or manic episodes in past year
• Substance/alcohol use disorder in past 6 months
• Diagnosed (previously or by the investigators' study screen) and untreated sleep disorder other than insomnia
• Sleep disorders diagnosed, but stably treated, such as obstructive sleep apnea treated with continuous positive airway pressure (CPAP), will be allowed)
• Participation in concurrent psychotherapies targeting PTSD
• Veteran can be reassessed after their PTSD treatment concludes
• Veterans who are engaged in treatment for non-PTSD symptoms (e.g., 12-step programs) will be eligible
• Severe medical or psychiatric illness that would make it difficult to regularly attend psychotherapy sessions or participate fully in the study
• History of moderate to severe cognitive impairment

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161, United States

Location

Related Publications (3)

• Colvonen PJ, Hunt C, Park J, Angkaw AC, Gehrman P, Clare K, Norman SB. Cognitive Behavioral Therapy for Insomnia With Prolonged Exposure Compared to Sleep Hygiene and Prolonged Exposure: A Randomized Controlled Trial. J Clin Psychiatry. 2025 Jun 4;86(3):24m15584. doi: 10.4088/JCP.24m15584.

  PMID: 40488726 DERIVED

• Park J, Hunt C, Abirgas K, Bomyea J, Colvonen PJ. Veterans who focus on sexual assault trauma show slower between-session habituation and symptom reduction during prolonged exposure treatment for posttraumatic stress disorder. Psychol Trauma. 2025 Jan;17(1):38-47. doi: 10.1037/tra0001536. Epub 2023 Jun 19.

  PMID: 37338445 DERIVED

• Lyons R, Barbir LA, Owens R, Colvonen PJ. STOP-BANG screener vs objective obstructive sleep apnea testing among younger veterans with PTSD and insomnia: STOP-BANG does not sufficiently detect risk. J Clin Sleep Med. 2022 Jan 1;18(1):67-73. doi: 10.5664/jcsm.9498.

  PMID: 34216197 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Limitations and Caveats

First, our study is limited in generalizability by an all-Veteran sample and may not fully overlap for civilians. Second, we used self-report measures of sleep. Future studies would do well to use polysomnography to capture the mechanistic effects of CBTI-PE on sleep architecture. Third, despite foundational power analyses from baseline, we were likely underpowered to capture effects of CBT-I on an active and effective treatment like PE.

Results Point of Contact

• Title: Dr. Peter Colvonen
• Organization: San Diego VA Healthcare System

peter.colvonen@va.gov

858-552-8585

Study Officials

• Peter Colvonen, PhD

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: May 17, 2016
• Study Start: October 1, 2016
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)