SuicideNCT04689867

Cognitive Behavioral Suicide Prevention for Psychosis: Aim 1

A study testing Cognitive Behavioral Suicide Prevention for psychosis CBSPp) in people with Suicide and Psychosis, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Suicide, Psychosis
What is being tested?: Cognitive Behavioral Suicide Prevention for psychosis CBSPp)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteUnited States
Study dates: 1 Sep 2021to 11 Apr 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Schizophrenia Spectrum Disorder
Suicide ideation and/or attempt within 3 months of screening
Ability to speak and read in English
18 to 65 years of age

Who cannot join

Requiring emergency care (e.g. imminent plan to harm self) as determined by trained research staff administering the Columbia-Suicide Severity Rating Scale (C-SSRS)
Inappropriate for behavioral treatment according to own judgment in consultation with a treating clinician CMH
Impaired capacity (cognitive capacity)

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: Feasibility, Acceptability, and Preliminary Effectiveness of a Cognitive-behavioral Suicide Prevention-focused Intervention Tailored to Adults Diagnosed With Schizophrenia Spectrum Disorders: Aim 1 Open Pilot Trial to Test Modified Treatment and Measurement Prior to Aim 2 RCT (Registered Separately)

The investigators are modifying and testing the preliminary effectiveness and implementation of a Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) intervention. In this phase of the study, CBSPp will be tested in an initial open trial (n = 10) to examine its feasibility and acceptability. Investigators will recruit clients receiving services at a community mental health setting who have a schizophrenia spectrum disorder and recent suicidal thoughts and behaviors to receive the behavioral intervention for 10-weeks. Providers will be recruited and trained to deliver the intervention. Both clients and providers will be assessed at baseline to test our approach to measurement prior to the Aim 2 RCT (registered separately). Clients will be assessed at three additional timepoints (middle of treatment, end of treatment, and 2 months after treatment ends.

Conditions: Suicide, Psychosis
Being tested: Cognitive Behavioral Suicide Prevention for psychosis CBSPp)
Keywords: cognitive behavioral therapy, suicide prevention, community mental health
Medical subject headings: Suicide, Psychotic Disorders, Suicide Prevention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cognitive Behavioral Suicide Prevention for psychosis CBSPp)Behavioural
Cognitive and behavioral approach to suicide prevention among individuals with psychosis

Study groups in NCT04689867
Study group	Role	What they receive
CBSPp	Experimental	Cognitive Behavioral Suicide Prevention for psychosis is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions. Receives: Behavioral: Cognitive Behavioral Suicide Prevention for psychosis CBSPp)

What is being measured

The primary outcome is the main question the study is designed to answer.

Calgary Depression Rating Scale (CDRS)
A scale to measure depression with scores ranging from 0 to 27 and greater scores indicating greater depression. Item 8 of the scale measures suicide thoughts and behaviors.
Measured: baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)
Positive and Negative Symptom Rating Scale (PANSS)
A scale to measure psychosis with item ratings ranging from 1 to 7. There are 3 sub-scales across 30 questions of the full scale: positive symptom scale (score range 7-49), negative symptom scale (score range 7-49), and general symptom scale (score range 16-112). Scores are summed for each of the 3 sub-scales with higher scores indicating greater presence of symptoms.
Measured: baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)
Columbia-Suicide Severity Rating Scale (C-SSRS)
A scale to measure suicide thoughts and behavior.
The following are C-SSRS items that have binary responses (yes/no): wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with some intent to act and without specific plan, active suicidal ideation with specific plan and intent, preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt (non-fatal), and suicide death.
A numerical suicidal ideation score is assigned for the first 5 binary items ranging from 0 (no ideation) to 5 (active ideation with plan and intent)
Measured: baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)

Secondary outcomes (3)

Beck Hopelessness Scale
A scale to measure hopelessness using 20 items with binary (true/false) response categories. Scores are summed and range from 0-20, higher scores indicate greater hopelessness is present.
Measured: baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)
The Entrapment Scale
A scale to measure entrapment using 16 items and response categories ranging from 0 to 4. Scores are summed with a range of 0 to 64, and higher scores indicate greater feelings of being entrapped.
Measured: baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)
The Defeat Scale
A scale to measure defeat using 16 items and response categories ranging from 0 to 4. Scores are summed with a range of 0 to 64, higher scores indicate greater feelings of being defeated.
Measured: baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 202111 Apr 2022

First posted30 Dec 2020
Study start1 Sep 2021
Primary completion1 Apr 2022
Study completion11 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SuicideStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04689867
Sponsor's protocol ID: HUM00152247
Other IDs: R34MH123609
Status last verified: Apr 2023
First submitted: 22 Dec 2020
Last updated: 24 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Upload to NIMH Data Archive

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Suicide trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility, Acceptability, and Preliminary Effectiveness of a Cognitive-behavioral Suicide Prevention-focused Intervention Tailored to Adults Diagnosed With Schizophrenia Spectrum Disorders: Aim 1 Open Pilot Trial to Test Modified Treatment and Measurement Prior to Aim 2 RCT (Registered Separately)
ClinicalTrials.gov ID: NCT04689867
Acronym / sponsor ID: HUM00152247
Conditions: Suicide, Psychosis
Keywords: cognitive behavioral therapy, suicide prevention, community mental health
Study type: Interventional
Recruitment status: Completed
Enrolment: 5 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 1 Sep 2021 (actual)
Primary completion: 1 Apr 2022 (actual)
Study completion: 11 Apr 2022 (actual)
First posted: 30 Dec 2020 (actual)
Results: Posted 24 Apr 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CBSPp	Experimental	Behavioral: Cognitive Behavioral Suicide Prevention for psychosis CBSPp)Cognitive Behavioral Suicide Prevention for psychosis is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Schizophrenia Spectrum Disorder
Suicide ideation and/or attempt within 3 months of screening
Ability to speak and read in English
18 to 65 years of age

Key exclusion criteria (3 listed)

Requiring emergency care (e.g. imminent plan to harm self) as determined by trained research staff administering the Columbia-Suicide Severity Rating Scale (C-SSRS)
Inappropriate for behavioral treatment according to own judgment in consultation with a treating clinician CMH
Impaired capacity (cognitive capacity)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cognitive Behavioral Suicide Prevention for psychosis CBSPp)Cognitive and behavioral approach to suicide prevention among individuals with psychosis	Behavioural	CBSPp

Primary outcome

Calgary Depression Rating Scale (CDRS)
Time frame: baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)
A scale to measure depression with scores ranging from 0 to 27 and greater scores indicating greater depression. Item 8 of the scale measures suicide thoughts and behaviors.
Positive and Negative Symptom Rating Scale (PANSS)
Time frame: baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)
A scale to measure psychosis with item ratings ranging from 1 to 7. There are 3 sub-scales across 30 questions of the full scale: positive symptom scale (score range 7-49), negative symptom scale (score range 7-49), and general symptom scale (score range 16-112). Scores are summed for each of the 3 sub-scales with higher scores indicating greater presence of symptoms.
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)
A scale to measure suicide thoughts and behavior. The following are C-SSRS items that have binary responses (yes/no): wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with some intent to act and without specific plan, active suicidal ideation with specific plan and intent, preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt (non-fatal), and suicide death. A numerical suicidal ideation score is assigned for the first 5 binary items ranging from 0 (no ideation) to 5 (active ideation with plan and intent)

3 secondary outcomes

Beck Hopelessness Scale
Time frame: baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)
The Entrapment Scale
Time frame: baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)
The Defeat Scale
Time frame: baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)

Results and safety

Results posted to the registry on 24 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CBSPp	5	5

Primary outcome: Calgary Depression Rating Scale (CDRS)

Time frame: baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment). Mean (Standard Deviation). Unit: score on a scale

Measure	CBSPp n = 5
Baseline	13.60 (5.73)
mid-treatment	9.00 (2.92)
post-treatment	11.00 (2.58)
follow-up	7.60 (3.65)

Primary outcome: Positive and Negative Symptom Rating Scale (PANSS)

Time frame: baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment). Mean (Standard Deviation). Unit: score on a scale

Measure	CBSPp n = 5
Baseline positive sub scale	20.20 (3.27)
Baseline negative sub scale	18.20 (5.89)
Baseline general sub scale	42.40 (7.96)
Mid-treatment positive sub scale	20.40 (4.16)
Mid-treatment negative sub scale	19.00 (7.81)
Mid-treatment general sub scale	41.20 (8.53)
Post-treatment positive sub scale	20.00 (7.62)
Post-treatment negative sub scale	17.75 (6.40)

Primary outcome: Columbia-Suicide Severity Rating Scale (C-SSRS)

Time frame: baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment). Count of participants. Unit: Participants

Measure	CBSPp n = 5
Baseline suicide ideation: Yes	3
Baseline suicide ideation: No	2
Baseline suicide plan: Yes	3
Baseline suicide plan: No	2
Baseline suicide attempt: Yes	0
Baseline suicide attempt: No	5
Mid-treatment suicide ideation: Yes	3
Mid-treatment suicide ideation: No	2

Population analysed: One individual at post-treatment did not complete the assessment with research staff

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data collected across participant involvement in study (beginning with the eligibility screener and ending after follow-up assessment): Approximately across 5 months per participant. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CBSPp	0 of 5 (0%)	1 of 5 (20%)	0 of 5

Limitations and caveats (from the sponsor): This was an open pilot trial, therefore no randomization occurred nor comparison between receiving treatment or not. All participants received treatment. The next phase of our study (Aim 2; registered separately) will report on the RCT.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Upload to NIMH Data Archive

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioral Suicide Prevention for psychosis CBSPp) in people with Suicide and Psychosis, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Calgary Depression Rating Scale (CDRS) (time frame: baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04689867.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2023.