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

NACompletedINTERVENTIONAL
Enrollment

94

Participants

Timeline

Start Date

October 1, 2016

Primary Completion Date

September 30, 2022

Study Completion Date

September 30, 2022

Conditions
Posttraumatic Stress DisordersChronic Insomnia
Interventions
BEHAVIORAL

CBTI-PE

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

BEHAVIORAL

Hygiene-PE

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.

Trial Locations (1)

92161

VA San Diego Healthcare System, San Diego, CA, San Diego

All Listed Sponsors
lead

VA Office of Research and Development

FED

NCT02774642 - Integrated CBT-I and PE on Sleep and PTSD Outcomes (Impact Study) | Biotech Hunter | Biotech Hunter