PsychosisCBTpNCT05584215
Cognitive Behavioural Therapy-Informed Groups for Psychosis
A study testing Cognitive Behavioural Therapy for Psychosis Groups in people with Psychosis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
Trial summary
This is a feasibility study of cognitive behavioural therapy-informed groups for psychiatric inpatients with positive symptoms of psychosis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychosis
- What is being tested?
- Cognitive Behavioural Therapy for Psychosis Groups
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 3 Jun 2023to 2 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Can read/write in English
- Has positive symptoms of psychosis that are distressing to them
Who cannot join
- Inability to tolerate group participation
About this study
This is a feasibility study of cognitive behavioural therapy-informed groups for psychiatric inpatients with positive symptoms of psychosis.
Read the detailed description
The majority of inpatients at Parkwood Institute Mental Health have symptoms of psychosis. In line with Health Quality Ontario standards for the treatment of psychosis, the investigators would like to implement and evaluate cognitive behavioural therapy for psychosis (CBTp) informed groups. The feasibility, acceptability, and preliminary efficacy of CBTp groups for inpatients will be examined. Pragmatically, the investigators propose to undergo training in CBTp, implement empirically-supported CBTp protocols developed for inpatients, track outcomes, and publish our findings. The investigators would also incorporate patient feedback to improve future iterations of the protocol. Such an undertaking would build research capacity in front line staff by encouraging engagement in CBTp group training, survey design, participant screening, data collection, analyses, and dissemination of findings.
- Conditions
- Psychosis
- Being tested
- Cognitive Behavioural Therapy for Psychosis Groups
- Keywords
- cognitive behavioral therapy
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural Therapy for Psychosis GroupsBehavioural
Groups based on cognitive behavioural therapy for psychosis
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment group will receive cognitive behavioural therapy informed groups for psychosis. Receives: Behavioral: Cognitive Behavioural Therapy for Psychosis Groups |
| Control | No intervention | Control group will be put on a waitlist to receive cognitive behavioural therapy informed groups for psychosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Outcomes in Routine Evaluation 10 (CORE-10)
The Clinical Outcomes in Routine Evaluation 10 is a short 10 item easy-to-use assessment measure for common presentations of psychological distress, designed to be used for screening as well as over the course of treatment to track progress. The minimum value is 0, the maximum value is 40, and higher scores indicate a worse outcome.
Measured: Up to 2 months
Process of Recovery Questionnaire (QPR)
The Process of Recovery Questionnaire is a 15 item questionnaire which was co-produced by people who experience psychosis and their accounts of recovery. The minimum value is 0, the maximum value is 60, and higher scores indicate a better outcome.
Measured: Up to 2 months
Secondary outcomes (1)
The Positive and Negative Syndrome Scale (PANSS) - Positive Symptoms
A brief measure of positive symptoms of psychosis. The minimum value is 7, the maximum values is 49. Higher scores indicate a worse outcome.
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start3 Jun 2023
- Primary completion2 Jan 2024 (estimated)
- Study completion2 Jan 2024 (estimated)
Why it stopped: PI transitioned to new role
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serena Wong, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Serena Wong, PhD, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584215
- Sponsor's protocol ID
- 12462
- Acronym
- CBTp
- Status last verified
- Oct 2024
- First submitted
- 30 Jun 2022
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioural Therapy-Informed Groups for Psychosis
- ClinicalTrials.gov ID
- NCT05584215
- Acronym / sponsor ID
- CBTp / 12462
- Conditions
- Psychosis
- Keywords
- cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI transitioned to new role
- Enrolment
- 0 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 3 Jun 2023 (actual)
- Primary completion
- 2 Jan 2024 (estimated)
- Study completion
- 2 Jan 2024 (estimated)
- First posted
- 18 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a feasibility study of cognitive behavioural therapy-informed groups for psychiatric inpatients with positive symptoms of psychosis.
Detailed description
The majority of inpatients at Parkwood Institute Mental Health have symptoms of psychosis. In line with Health Quality Ontario standards for the treatment of psychosis, the investigators would like to implement and evaluate cognitive behavioural therapy for psychosis (CBTp) informed groups. The feasibility, acceptability, and preliminary efficacy of CBTp groups for inpatients will be examined. Pragmatically, the investigators propose to undergo training in CBTp, implement empirically-supported CBTp protocols developed for inpatients, track outcomes, and publish our findings. The investigators would also incorporate patient feedback to improve future iterations of the protocol. Such an undertaking would build research capacity in front line staff by encouraging engagement in CBTp group training, survey design, participant screening, data collection, analyses, and dissemination of findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Cognitive Behavioural Therapy for Psychosis GroupsTreatment group will receive cognitive behavioural therapy informed groups for psychosis. |
| Control | No intervention | –Control group will be put on a waitlist to receive cognitive behavioural therapy informed groups for psychosis. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Can read/write in English
- Has positive symptoms of psychosis that are distressing to them
Key exclusion criteria (1 listed)
- Inability to tolerate group participation
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 Behavioural Therapy for Psychosis GroupsGroups based on cognitive behavioural therapy for psychosis | Behavioural | Treatment |
Primary outcome
Clinical Outcomes in Routine Evaluation 10 (CORE-10)
Time frame: Up to 2 months
The Clinical Outcomes in Routine Evaluation 10 is a short 10 item easy-to-use assessment measure for common presentations of psychological distress, designed to be used for screening as well as over the course of treatment to track progress. The minimum value is 0, the maximum value is 40, and higher scores indicate a worse outcome.
Process of Recovery Questionnaire (QPR)
Time frame: Up to 2 months
The Process of Recovery Questionnaire is a 15 item questionnaire which was co-produced by people who experience psychosis and their accounts of recovery. The minimum value is 0, the maximum value is 60, and higher scores indicate a better outcome.
1 secondary outcome
The Positive and Negative Syndrome Scale (PANSS) - Positive Symptoms
Time frame: Up to 2 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Serena Wong, PhD principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioural Therapy for Psychosis Groups in people with Psychosis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Clinical Outcomes in Routine Evaluation 10 (CORE-10) (time frame: Up to 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2024; AzTrials last refreshed its copy on 28 Oct 2026.