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NCT05345184

Cognitive Behavioral Suicide Prevention for Psychosis: Aim 2

Completed NA Results posted Last updated 20 March 2026
What this trial tests

NA trial testing Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) in Suicide in 51 participants. Completed in 1 May 2025.

Timeline
1 September 2022
Primary endpoint
1 May 2025
1 May 2025

Quick facts

Lead sponsorUniversity of Michigan
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment51
Start date1 September 2022
Primary completion1 May 2025
Estimated completion1 May 2025
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Michigan

Who can join

Adults 18 to 65, any sex, with Suicide 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.

Calgary Depression Rating Scale (CDRS) Primary · 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months).

A scale to measure depression, higher scores indicate greater depression (range of 0-27)

Baseline
GroupValue95% CI
Cognitive Behavioral Suicide Prevention for Psychosis (Treatment Group)18.20± 4.65
Services as Usual (SAU; Comparison Group)17.15± 4.58
Mid-treatment
GroupValue95% CI
Cognitive Behavioral Suicide Prevention for Psychosis (Treatment Group)16.09± 3.78
Services as Usual (SAU; Comparison Group)15.39± 4.59
Post-treatment
GroupValue95% CI
Cognitive Behavioral Suicide Prevention for Psychosis (Treatment Group)13.95± 3.20
Services as Usual (SAU; Comparison Group)15.83± 5.26
Follow-up
GroupValue95% CI
Cognitive Behavioral Suicide Prevention for Psychosis (Treatment Group)13.55± 3.59
Services as Usual (SAU; Comparison Group)14.19± 3.68
Positive and Negative Syndrome Scale (PANSS) Primary · 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months).

A scale to measure psychosis symptoms, higher scores indicate greater psychosis (range of 30-210)

baseline
GroupValue95% CI
Cognitive Behavioral Suicide Prevention for Psychosis (Treatment Group)82.72± 13.58
Services as Usual (SAU; Comparison Group)75.27± 15.79
mid-treatment
GroupValue95% CI
Cognitive Behavioral Suicide Prevention for Psychosis (Treatment Group)77.68± 12.64
Services as Usual (SAU; Comparison Group)71.69± 16.29
post-treatment
GroupValue95% CI
Cognitive Behavioral Suicide Prevention for Psychosis (Treatment Group)71.57± 12.64
Services as Usual (SAU; Comparison Group)76.96± 16.92
follow-up
GroupValue95% CI
Cognitive Behavioral Suicide Prevention for Psychosis (Treatment Group)74.40± 17.58
Services as Usual (SAU; Comparison Group)71.09± 13.71
Columbia Suicide Severity Rating Scale (C-SSRS) Primary · 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months).

A scale to measure suicide thoughts and behavior, higher scores indicate greater suicide thoughts and behavior (range of 0-5)

baseline
GroupValue95% CI
Cognitive Behavioral Suicide Prevention for Psychosis (Treatment Group)2.52± 1.23
Services as Usual (SAU; Comparison Group)1.77± 1.56
mid-treatment
GroupValue95% CI
Cognitive Behavioral Suicide Prevention for Psychosis (Treatment Group)1.45± 1.65
Services as Usual (SAU; Comparison Group)1.48± 1.34
post-treatment
GroupValue95% CI
Cognitive Behavioral Suicide Prevention for Psychosis (Treatment Group)1.09± 1.51
Services as Usual (SAU; Comparison Group)1.52± 1.68
follow-up
GroupValue95% CI
Cognitive Behavioral Suicide Prevention for Psychosis (Treatment Group)1.05± 1.50
Services as Usual (SAU; Comparison Group).86± 1.19
Beck Hopelessness Scale Secondary · 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months).

A scale to measure hopelessness, higher scores indicate greater hopelessness (range of 0-20)

baseline
GroupValue95% CI
Cognitive Behavioral Suicide Prevention for Psychosis (Treatment Group)7.04± 5.33
Services as Usual (SAU; Comparison Group)7.85± 5.65
mid-treatment
GroupValue95% CI
Cognitive Behavioral Suicide Prevention for Psychosis (Treatment Group)5.67± 4.72
Services as Usual (SAU; Comparison Group)7.0± 5.46
post-treatment
GroupValue95% CI
Cognitive Behavioral Suicide Prevention for Psychosis (Treatment Group)4.0± 3.63
Services as Usual (SAU; Comparison Group)7.26± 5.82
follow-up
GroupValue95% CI
Cognitive Behavioral Suicide Prevention for Psychosis (Treatment Group)4.60± 5.28
Services as Usual (SAU; Comparison Group)6.0± 5.97
Defeat Scale (D Scale) Secondary · 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months).

A scale to measure defeat, higher scores indicate greater defeat (range of 0-64)

baseline
GroupValue95% CI
Cognitive Behavioral Suicide Prevention for Psychosis (Treatment Group)31.24± 15.86
Services as Usual (SAU; Comparison Group)32.19± 12.76
mid-treatment
GroupValue95% CI
Cognitive Behavioral Suicide Prevention for Psychosis (Treatment Group)27.57± 14.28
Services as Usual (SAU; Comparison Group)28.52± 14.80
post-treatment
GroupValue95% CI
Cognitive Behavioral Suicide Prevention for Psychosis (Treatment Group)22.71± 13.12
Services as Usual (SAU; Comparison Group)27.61± 13.71
follow-up
GroupValue95% CI
Cognitive Behavioral Suicide Prevention for Psychosis (Treatment Group)22.65± 15.23
Services as Usual (SAU; Comparison Group)27.90± 15.05
The Entrapment Scale Secondary · 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months).

A scale to measure entrapment, higher scores indicate greater entrapment (range of 0-64)

baseline
GroupValue95% CI
Cognitive Behavioral Suicide Prevention for Psychosis (Treatment Group)28.12± 17.84
Services as Usual (SAU; Comparison Group)22.04± 14.96
mid-treatment
GroupValue95% CI
Cognitive Behavioral Suicide Prevention for Psychosis (Treatment Group)27.62± 18.63
Services as Usual (SAU; Comparison Group)23.83± 16.34
post-treatment
GroupValue95% CI
Cognitive Behavioral Suicide Prevention for Psychosis (Treatment Group)18.33± 15.60
Services as Usual (SAU; Comparison Group)27.14± 16.28
follow-up
GroupValue95% CI
Cognitive Behavioral Suicide Prevention for Psychosis (Treatment Group)17.55± 15.15
Services as Usual (SAU; Comparison Group)24.0± 16.46

Adverse events — posted to ClinicalTrials.gov

Time frame: between baseline assessment at 5 month assessment (follow up). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cognitive Behavioral Suicide Prevention for Psychosis (Treatment Group)
Serious: 2/25 (8%)
Deaths: 0/25
Services as Usual (SAU; Comparison Group)
Serious: 5/26 (19%)
Deaths: 0/26

Serious adverse events (2 terms)

ReactionSystemCognitive Behavioral Suici…Services as Usual (SAU; Co…
Psychiatric hospitalizationPsychiatric disorders
Medical hospitalizationGeneral disorders

Most-reported serious reactions: Psychiatric hospitalization, Medical hospitalization.

Data from ClinicalTrials.gov NCT05345184 adverse events section.

Sponsor's own description

Investigators will evaluate the feasibility and preliminary effectiveness of modified Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) in comparison to services-as-usual (SAU) in a randomized controlled trial. Investigators will recruit adult clients receiving services at a community mental health (CMH) setting who have a schizophrenia spectrum disorder and recent suicidal thoughts or behaviors within 3 months of screening (n=60). Client participants will be screened, enrolled and randomized to the CBSPp or SAU group. A 4-wave design will include quantitative assessments at baseline (T1), 1-month after baseline (T2), 3-months after baseline (T3), and 5-months after baseline (T4) with in-depth qualitative interviews at T3 for a random sample of adults in the CBSPp group (n=10). Providers (n=12) will be trained to deliver CBSPp and be assessed from T1-T3 to evaluate the implementation process, including in-depth qualitative interviews at T3.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Suicide

Currently open trials in the same condition.

Other University of Michigan trials

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