N/A
Completed N=94
Integrated CBT-I and PE on Sleep and PTSD Outcomes (Impact Study)
Posttraumatic Stress Disorders · Insomnia
Source: ClinicalTrials.gov NCT02774642 ↗
Enrolled (actual)
94
Serious AEs
1.3%
Results posted
Oct 2024
Primary outcomePrimary: Change in PTSD Symptoms — 25.74; 28.18; 28.59; 24.93 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in PTSD Symptoms |
25.74; 28.18; 28.59; 24.93 | — |
| PRIMARY Change in Sleep Efficiency |
88.71; 78.44; 86.46; 78.23 | — |
| SECONDARY Change in Quality of Life |
11.6; 10.53; 10.12; 12.11; 10.46; 10.26 | — |
| SECONDARY Change in Insomnia Severity |
15.13; 17.69; 9.46; 12.93; 11.76; 12.37 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02774642). 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. Informational only — not medical advice.