NCT02774642

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

Completed NA Results posted Last updated 8 October 2024

What this trial tests

NA trial testing CBTI-PE in Posttraumatic Stress Disorders in 94 participants. Completed in 30 September 2022.

Timeline

1 October 2016

Primary endpoint
30 September 2022

30 September 2022

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	94
Start date	1 October 2016
Primary completion	30 September 2022
Estimated completion	30 September 2022
Sites	1 location across United States

Drugs / interventions tested

• CBTI-PE
• Hygiene-PE

Conditions studied

• Posttraumatic Stress Disorders — all drugs for Posttraumatic Stress Disorders →
• Chronic Insomnia — all drugs for Chronic Insomnia →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

19 and older, any sex, with Posttraumatic Stress Disorders or Chronic Insomnia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in PTSD Symptoms Primary · Baseline, Post Treatment (14-weeks), Follow-up (26-weeks)

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.

Post-Treatment

Group	Value	95% CI
CBTI-PE	25.74	± 12.34
Hygiene-PE	28.18	± 11.62

3 Month Follow-up

Group	Value	95% CI
CBTI-PE	28.59	± 12.68
Hygiene-PE	24.93	± 12.61

Change in Sleep Efficiency Primary · Baseline, Post Treatment (14-weeks), Follow-up (26-weeks)

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.

Post-Treatment

Group	Value	95% CI
CBTI-PE	88.71	± 6.46
Hygiene-PE	78.44	± 9.71

3 Month Follow-Up

Group	Value	95% CI
CBTI-PE	86.46	± 7.67
Hygiene-PE	78.23	± 10.86

Change in Quality of Life Secondary · Baseline, Post Treatment (14-weeks), Follow-up (26-weeks)

Change in Quality of life will be assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire. All subscores, higher scores equate to better quality of life. Physical Health Range (7-35); Psychological Range (6-30); Social Relationships (3-15); Environment (8-40).

Physical Health - Post TX

Group	Value	95% CI
CBTI-PE	11.6	± 5.32
Hygiene-PE	10.53	± 6.44

Physical Health - 3m

Group	Value	95% CI
CBTI-PE	10.12	± 6.14
Hygiene-PE	12.11	± 7.56

Psychological - post treatment

Group	Value	95% CI
CBTI-PE	10.46	± 4.81
Hygiene-PE	10.26	± 6.13

Psychological - 3m

Group	Value	95% CI
CBTI-PE	9.31	± 5.77
Hygiene-PE	11.64	± 4.99

Social relationships - post-TX

Group	Value	95% CI
CBTI-PE	10.63	± 5.05
Hygiene-PE	9.49	± 5.98

Social relationships - 3m

Group	Value	95% CI
CBTI-PE	9.61	± 6.46
Hygiene-PE	11.24	± 4.99

Environment - post-tx

Group	Value	95% CI
CBTI-PE	12.13	± 5.22
Hygiene-PE	11.08	± 6.34

Environment - 3m

Group	Value	95% CI
CBTI-PE	11.15	± 6.56
Hygiene-PE	12.94	± 5.31

Change in Insomnia Severity Secondary · Baseline, week 5, Post Treatment (14-weeks), Follow-up (26-weeks)

Insomnia Severity will be assessed using the Insomnia Severity Index (ISI). Range (0 - 28). Lower scores equate to lower insomnia severity. Change in ISI will be assessed longitudinally using linear mixed effects models of the ISI scores at each timepoint to estimate slope (change) over time.

Week 5

Group	Value	95% CI
CBTI-PE	15.13	± 6.50
Hygiene-PE	17.69	± 4.76

Post-Treatment

Group	Value	95% CI
CBTI-PE	9.46	± 6.98
Hygiene-PE	12.93	± 6.58

3 Month Follow-up

Group	Value	95% CI
CBTI-PE	11.76	± 6.70
Hygiene-PE	12.37	± 7.57

The Client Satisfaction Questionnaire (CSQ) Secondary · Post Treatment ( up to 14-weeks)

CSQ assesses client satisfaction for therapy session. Range (8-32) with higher scores equating to higher satisfaction.

Group	Value	95% CI
CBTI-PE	29.41	± 3.11
Hygiene-PE	29.56	± 2.97

Brief Pain Inventory Secondary · post treatment, and 3-month follow-ups presented.

Brief Pain Inventory ranges from 0 - 40, with higher score indicating worse pain.

Post-Treatment

Group	Value	95% CI
CBTI-PE	18.69	± 9.14
Hygiene-PE	15.63	± 10.12

3 Month Follow-up

Group	Value	95% CI
CBTI-PE	18.41	± 7.81
Hygiene-PE	16.08	± 9.94

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were tracked for the duration of our study ( from baseline until3-month follow-up assessment date, up to 26 weeks).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

CBTI-PE

Serious: 1/43 (2%)

Deaths: 0/43

Hygiene-PE

Serious: 0/35 (0%)

Deaths: 0/35

Serious adverse events (1 terms)

Reaction	System	CBTI-PE	Hygiene-PE
Suicidal ideation	General disorders	—	—

Most-reported serious reactions: Suicidal ideation.

Data from ClinicalTrials.gov NCT02774642 adverse events section.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Treatment of Sleep Comorbidities in Posttraumatic Stress Disorder.
   Brownlow JA, Miller KE, Gehrman PR. · · 2020 · cited 13× · PMID 33552844 · DOI 10.1007/s40501-020-00222-y
2. STOP-BANG screener vs objective obstructive sleep apnea testing among younger veterans with PTSD and insomnia: STOP-BANG does not sufficiently detect risk.
   Lyons R, Barbir LA, Owens R, Colvonen PJ. · · 2022 · cited 10× · PMID 34216197 · DOI 10.5664/jcsm.9498
3. Sleep efficiency predicts improvements in fear extinction and PTSD symptoms during prolonged exposure for veterans with comorbid insomnia.
   Hunt C, Park J, Bomyea J, Colvonen PJ. · · 2023 · cited 8× · PMID 37099850 · DOI 10.1016/j.psychres.2023.115216
4. Cognitive Behavioral Therapy for Insomnia With Prolonged Exposure Compared to Sleep Hygiene and Prolonged Exposure: A Randomized Controlled Trial.
   Colvonen PJ, Hunt C, Park J, Angkaw AC, et al · · 2025 · cited 1× · PMID 40488726 · DOI 10.4088/jcp.24m15584
5. Veterans who focus on sexual assault trauma show slower between-session habituation and symptom reduction during prolonged exposure treatment for posttraumatic stress disorder.
   Park J, Hunt C, Abirgas K, Bomyea J, et al · · 2025 · PMID 37338445 · DOI 10.1037/tra0001536