Adults 18 to 80, any sex, with Insomnia or Psychosis. 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.
Insomnia Severity Index (ISI)Primary· Participants will be assessed following completion of the study intervention, an expected average of 10 weeks.
ISI score; scored on a scale of 0 to 28, with higher scores indicating worse insomnia severity.
Group
Value
95% CI
Cognitive Behavioral Therapy-Insomnia
11.6
± 7.5
Health and Wellness
15.2
± 4.5
Insomnia Severity Index (ISI)Secondary· Participants will be assessed a second time following completion of the study intervention, an expected average of 22 weeks.
ISI score; scored on a scale of 0 to 28, with higher scores indicating worse insomnia severity.
Group
Value
95% CI
Cognitive Behavioral Therapy-Insomnia
12.4
± 7.4
Health and Wellness
13.0
± 6.0
Veterans RAND 36-Item Health Survey Mental Component ScoreSecondary· Participants will be assessed following completion of the study intervention, an expected average of 10 weeks.
Veterans RAND 36-Item Health Survey score Mental Component Score; Possible scores range from 0 to 100, with higher scores indicating greater mental quality of life.
Group
Value
95% CI
Cognitive Behavioral Therapy-Insomnia
40.0
± 13.8
Health and Wellness
45.5
± 10.8
Veterans RAND 36-Item Health Survey Mental Component ScoreSecondary· Participants will be assessed a second time following completion of the study intervention, an expected average of 22 weeks.
Veterans RAND 36-Item Health Survey Mental Component Score; Possible scores range from 0 to 100, with higher scores indicating greater mental health quality of life.
Group
Value
95% CI
Cognitive Behavioral Therapy-Insomnia
48.4
± 12.2
Health and Wellness
47.8
± 12.6
World Health Organization Disability Assessment Schedule (WHO-DAS), Participation in Society SubscaleSecondary· Participants will be assessed following completion of the study intervention, an expected average of 10 weeks.
WHO-DAS score; scores range from 0 to 100 where 100 is full disability.
Group
Value
95% CI
Cognitive Behavioral Therapy-Insomnia
39.9
± 22.3
Health and Wellness
34.1
± 25.8
World Health Organization Disability Assessment Schedule (WHO-DAS), Participation in Society SubscaleSecondary· Participants will be assessed a second time following completion of study intervention, an estimated average of 22 weeks.
WHO-DAS score; scores range from 0 to 100 where 100 is full disability.
Group
Value
95% CI
Cognitive Behavioral Therapy-Insomnia
42.9
± 22.7
Health and Wellness
29.6
± 15.6
Adverse events — posted to ClinicalTrials.gov
Time frame: From baseline to an average of 22 weeks per participant..
Reporting threshold: 3%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The goal of this project is to develop guidelines for the clinical tailoring of Cognitive Behavioral Therapy for Insomnia (CBT-I) for Veterans with psychotic disorders and insomnia, and to test the acceptability, feasibility, and preliminary efficacy of CBT-I for improving sleep-related functional outcomes in this population.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
Other trials of Cognitive Behavioral Therapy-Insomnia
Trials testing the same drug.
NCT04646200 — CBT-I to Improve Functional Outcomes in Veterans With Psychosis
· NA
· active not recruiting
NCT04919993 — CBT for Insomnia in Primary Brain Tumor Patients
· NA
· completed
Other recruiting trials for Insomnia
Currently open trials in the same condition.
NCT07384429 — Effects of Lemborexant on Motor-sleep Comorbidity in Parkinson's Disease
· Phase 4
· recruiting
NCT07270406 — Healthy Behaviors for Insomnia Prevention in People With HIV and Ongoing Pain
· NA
· recruiting
NCT07071324 — CF Wellness Program
· NA
· recruiting
NCT07417813 — A Multicenter Observational Study of Lemborexant on Insomnia Patients With Psychiatric Disorders
· recruiting
NCT06348082 — Project Women's Insomnia Sleep Health Equity Study (WISHES)
· NA
· recruiting
Other VA Office of Research and Development trials
Trials by the same sponsor.
NCT07456150 — Personalizing Veteran Pain Care: Adapting Coaching Interventions to Support Maintenance of Self-Care
· Phase 1
· not yet recruiting
NCT06746727 — The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veteran
· NA
· not yet recruiting
NCT07362576 — Perinatal Peer Support for Veterans With Serious Mental Illness
· NA
· not yet recruiting
NCT06766331 — Integrated Care Versus Usual Care for Opioid Use Disorder and Infectious Diseases in Veterans
· NA
· not yet recruiting
NCT07397195 — ACT for Veterans With IBD and Mental Health Challenges
· NA
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
Last refreshed: 16 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02535923.