Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Insomnia
  • Psychosis
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 80 years
Gender
Both males and females

Description

The goal of this project is to examine the efficacy of Cognitive Behavioral Therapy for Insomnia (CBT-I) for improving sleep and related functional outcomes in Veterans with psychosis and insomnia. Aim 1: Evaluate the efficacy of CBT-I for reducing insomnia severity in Veterans with psychosis and in...

The goal of this project is to examine the efficacy of Cognitive Behavioral Therapy for Insomnia (CBT-I) for improving sleep and related functional outcomes in Veterans with psychosis and insomnia. Aim 1: Evaluate the efficacy of CBT-I for reducing insomnia severity in Veterans with psychosis and insomnia. Hypothesis 1: CBT-I participants, as compared to those in an active control condition, will show significantly greater reductions on the Insomnia Severity Index at post-treatment and at a 6-month follow-up. Aim 2: Evaluate the efficacy of CBT-I for improving the functioning of Veterans with psychosis and insomnia. Hypothesis 2: CBT-I participants, as compared to those in an active control condition, will show significantly greater increases in mental and physical health functioning on the Veterans RAND 36-Item Health Survey at post-treatment and at a 6-month follow-up. Aim 3: Evaluate the process that underlies the relationship between insomnia severity and functioning in Veterans with psychosis and insomnia. Hypothesis 3: The effect of CBT-I on mental and physical health functioning at post-treatment will be mediated by reductions in insomnia severity at week 5 of treatment. Hypothesis 4: The effect of CBT-I on mental and physical health functioning at the 6-month follow-up will be mediated by reductions in insomnia severity at immediate post-treatment. Exploratory Aim: Explore whether psychiatric symptoms 1) moderate the impact of CBT-I on insomnia and functioning and/or 2) change as a result of participation in CBT-I.

Tracking Information

NCT #
NCT04646200
Collaborators
Not Provided
Investigators
Principal Investigator: Elizabeth A. Klingaman, PhD Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD