CBT-I to Improve Functional Outcomes in Veterans With Psychosis

Last updated: March 13, 2025
Sponsor: VA Office of Research and Development
Overall Status: Active - Recruiting

Phase

N/A

Condition

Psychosis

Insomnia

Schizotypal Personality Disorder (Spd)

Treatment

Cognitive Behavioral Therapy-Insomnia

Health and Wellness

Clinical Study ID

NCT04646200
D3213-R
I01RX003213
  • Ages 18-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • meet criteria for SMI: Schizophrenic disorder, affective psychosis, major depressionwith psychotic features, delusional disorder, brief psychotic disorder, unspecifiedpsychotic disorder, schizotypal personality disorder

  • be between the ages of 18 and 80

  • be actively participating in outpatient mental health services at designated site

Exclusion

Exclusion Criteria:

  • currently in CBT-I treatment

  • planning to move out of the area during the study period

Study Design

Total Participants: 156
Treatment Group(s): 2
Primary Treatment: Cognitive Behavioral Therapy-Insomnia
Phase:
Study Start date:
November 29, 2021
Estimated Completion Date:
June 01, 2026

Study 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 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.

Connect with a study center

  • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

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