PsychosisNCT07777315
Group Dialectical Behaviour Therapy (DBT) Skills Training for First Episode Psychosis
A study testing group DBT in people with Psychosis, run by Centre for Addiction and Mental Health.
Trial summary
Psychosis is a serious mental health condition that can affect how a person thinks, feels, and functions in daily life, often making it harder to maintain relationships, continue education, or work. Read more about this study
- Who is it for?
- Ages 14 to 35 years
- Conditions the study is for
- Psychosis
- What is being tested?
- group DBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Be 14-35 years old.
- All gender identities are eligible to participate.
- Being competent as demonstrated by comprehension of the study procedures, risks, benefits and their rights as a volunteer in the research study and willing to consent to study participation.
- Meets criteria for a psychotic spectrum disorder as determined by Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (e.g., schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, delusional disorder, other specified schizophrenia spectrum disorder, or other unspecified schizophrenia spectrum disorder), or bipolar disorder with psychotic features, and is within 3 years of their initial diagnosis.
Who cannot join
- Diagnosis of intellectual disability previously documented in the patient chart.
- Acute suicidality requiring immediate life-saving intervention (i.e., inpatient psychiatric care).
- Receiving any additional structured psychotherapy interventions during the study period.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Group Dialectical Behaviour Therapy (DBT) Skills Training for Individuals With First Episode Psychosis: a Feasibility Study
Psychosis is a serious mental health condition that can affect how a person thinks, feels, and functions in daily life, often making it harder to maintain relationships, continue education, or work. Even with standard treatment, many people continue to experience emotional distress, depression, anxiety, and difficulty coping with strong emotions. These challenges can worsen recovery, increase the risk of substance use and suicidal behaviour, and place a significant burden on individuals, families, and the healthcare system.
Dialectical Behaviour Therapy (DBT) is a skills-based psychological treatment that helps people manage emotions, tolerate distress, and improve relationships. Although DBT has been effective in other mental health conditions, it has not been well studied in people with first-episode psychosis.
This study will evaluate an 8-week group DBT skills training adapted for individuals with first-episode psychosis. The study aims to assess whether the program is acceptable and feasible to deliver, and whether it may improve emotion regulation, mood, resilience, and functioning. Findings will inform whether a larger clinical trial of this intervention should be conducted.
Read the detailed description
Despite evidence that individuals with psychotic disorders experience marked emotion dysregulation, impulsivity and elevated suicide risk, they have largely been excluded from clinical trials evaluating DBT. Nevertheless, emerging pilot studies support the feasibility and potential efficacy of brief DBT-informed skills group in individuals with psychosis, with participants reporting high satisfaction and improvements in understanding and managing emotions, suicidality, and interpersonal functioning. However, this literature remains preliminary and underdeveloped, and no studies have evaluated group DBT skills intervention specifically for individuals with first-episode psychosis.
Aim 1: To evaluate the acceptability of the group DBT skills training invention and the feasibility of conducting a fully powered randomized controlled trial (RCT) of in young men with psychosis.
Aim 2: To assess the preliminary efficacy of group DBT skills training in improving emotion regulation, resilience, and functioning and reducing, mood and anxiety and substance use, in a single-arm exploratory clinical trial.
This study will provide evidence of the feasibility, acceptability, and preliminary efficacy of a group DBT skills training for young men with first-episode psychosis. Findings will advance understanding of emotion regulation as a treatment target in psychosis and inform the development of larger controlled trials evaluating emotion-focused interventions in early psychosis care. The intervention could represent a scalable and practical psychosocial treatment to address emotional difficulties that are common but often under-treated in psychosis.
This study employing qualitative and quantitative methods to evaluate the group DBT skills training intervention and test its feasibility, and acceptability in individuals with psychosis. A single arm trial where DBT skills group delivered over 8-weeks, will be conducted. Thirty-two participants are planned to be enrolled in the trial. Participants will continue with their standard outpatient care during the trial. Outcome measures will be completed at study entry and post-treatment. For the qualitative component of the study, 15 post-intervention semi-structured interviews will be conducted.
- Conditions
- Psychosis
- Being tested
- group DBT
- Keywords
- Psychosis, DBT, Group 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.
group DBTBehavioural
DBT skills group delivered over 8-weeks
| Study group | Role | What they receive |
|---|---|---|
| Group DBT | Experimental | Receive 8-week Group DBT intervention Receives: Behavioral: group DBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
Percent sessions attended
Measured: post treatment (8 weeks after baseline)
Retention rates
Percent participants who complete 8-week study.
Measured: post treatment (8 weeks after baseline)
Attrition
Percent participants that dropout at 8 weeks
Measured: post treatment (8 weeks after baseline)
Client Satisfaction Questionnaire
A Likert scale from 1-4, total scores range from 8-32, with higher scores indicating greater satisfaction.
Measured: post treatment (8 weeks after baseline)
Timeline Follow Back (TLFB)
A self-report method for substance use, and will be used to quantify the amount/frequency of cannabis in the past 14 days.
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (11)
Brief Psychiatric Rating Scale (BPRS)
a widely used instrument for the assessment of positive, negative and affective symptoms in individuals who have psychotic disorders. It consists of 18 symptom constructs. Total score range from 18-126, higher scores indicating higher severity.
Measured: From enrollment to the end of treatment at 8 weeks
Scale for the Assessment of Negative Symptoms (SANS)
An instrument for measuring negative symptoms in schizophrenia. It assesses five symptom complexes to obtain clinical ratings of negative symptoms in participants with schizophrenia. They are: affective blunting; alogia (impoverished thinking); avolition/apathy; anhedonia/asociality; and disturbance of attention. Assessments are conducted on a six-point scale (0=not at all to 5=severe). Total score range from 0-110, higher scores indicating higher severity.
Measured: From enrollment to the end of treatment at 8 weeks
Calgary Depression Scale for Schizophrenia (CDSS)
4-point Likert type scale (0, absent; 1, mild; 2, moderate; 3, severe) with nine items. It is a reliable scale, with high internal consistency (Cronbach's alpha = 0.855), and the CDSS is suitable for evaluating symptoms of depression in people at clinical high risk for psychosis Total score range from 0-27, higher scores indicating higher severity.
Measured: From enrollment to the end of treatment at 8 weeks
State-Trait Anxiety Inventory (STAI)
A psychological inventory consisting of 40 self-report items on a 4-point Likert scale. The STAI measures two types of anxiety - state anxiety and trait anxiety. Scores range from 20 to 80 for both state and trait anxiety, with higher scores indicating greater anxiety.
Measured: From enrollment to the end of treatment at 8 weeks
Borderline Symptom List (BSL-23)
A well-established self-rating instrument to assess the severity of borderline typical psychopathology. The BSL-23 assesses 23 feelings and experiences typically reported by BPD patients, refers to the last week and has a range from 0 = 'not at all' to 4 = 'very strong. scores range from 0 to 92 with higher scores indicating greater symptom severity.
Measured: From enrollment to the end of treatment at 8 weeks
Difficulties in emotion regulation scale (DERS)
A 36-item self-report measure of six facets of emotion regulation. Items are rated on a scale of 1 ("almost never [0-10%]") to 5 ("almost always [91-100%]"). Scores range from 36 to 180, with higher scores indicating greater symptom severity.
Measured: From enrollment to the end of treatment at 8 weeks
Global Functioning: Social and Role Scales
Brief clinician-administered measures of social and role functioning, respectively, administered as a semi-structured interview with detailed anchors for ratings that address functional difficulties typically experienced by youth at risk for psychosis. Scores range from 1 to 10, with higher scores indicating greater functioning.
Measured: From enrollment to the end of treatment at 8 weeks
Connor-Davidson Resilience Scale (CD-RISC)
A 25-item self-report rating scale designed to assess resilience, with higher scores being an indicator of high resilience. Each item is rated on a 5-point scale ranging from not true at all or zero to true nearly all the time or four. Scores range from 0 to 100, with higher scores indicating greater resilience.
Measured: From enrollment to the end of treatment at 8 weeks
Adolescent Alcohol and Drug Involvement Scale (AADIS)
A clinician rated instrument which evaluates an adolescent's use of alcohol and other drugs. The score is calculated from a weighted sum of item ratings on a scale of 1-12, where higher scores indicate more serious levels of involvement.
Measured: From enrollment to the end of treatment at 8 weeks
Cannabis Use Disorders Identification Test-Revised (CUDIT-R)
A self-report tool developed that aim to distinguish between different levels of cannabis use, cannabis use disorders and stage of change. It contains 8 items, two each from the domains of consumption, cannabis problems (abuse), dependence, and psychological features. score range 0-32, more indicating hazardous cannabis use and scores of 12 or more suggesting a possible cannabis use disorder
Measured: From enrollment to the end of treatment at 8 weeks
Columbia-Suicide Severity Rating Scale (C-SSRS)
A semi-structured clinical interview that assesses suicidal ideation severity, suicidal ideation intensity, and suicidal behavior. intensity subscale (scored separately) that ranges from 0-25 by rating the frequency, duration, and controllability of ideation. Overall Score 0: No suicidal risk Score 1-2: Low risk; safety planning recommended as a best practice Score 3-6: Moderate to high risk; requires safety planning and close follow-up
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start15 Sep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777315
- Sponsor's protocol ID
- 2026/060
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Dialectical Behaviour Therapy (DBT) Skills Training for Individuals With First Episode Psychosis: a Feasibility Study
- ClinicalTrials.gov ID
- NCT07777315
- Acronym / sponsor ID
- 2026/060
- Conditions
- Psychosis
- Keywords
- Psychosis, DBT, Group therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 20 Aug 2026 (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.
Psychosis is a serious mental health condition that can affect how a person thinks, feels, and functions in daily life, often making it harder to maintain relationships, continue education, or work. Even with standard treatment, many people continue to experience emotional distress, depression, anxiety, and difficulty coping with strong emotions. These challenges can worsen recovery, increase the risk of substance use and suicidal behaviour, and place a significant burden on individuals, families, and the healthcare system.
Dialectical Behaviour Therapy (DBT) is a skills-based psychological treatment that helps people manage emotions, tolerate distress, and improve relationships. Although DBT has been effective in other mental health conditions, it has not been well studied in people with first-episode psychosis.
This study will evaluate an 8-week group DBT skills training adapted for individuals with first-episode psychosis. The study aims to assess whether the program is acceptable and feasible to deliver, and whether it may improve emotion regulation, mood, resilience, and functioning. Findings will inform whether a larger clinical trial of this intervention should be conducted.
Detailed description
Despite evidence that individuals with psychotic disorders experience marked emotion dysregulation, impulsivity and elevated suicide risk, they have largely been excluded from clinical trials evaluating DBT. Nevertheless, emerging pilot studies support the feasibility and potential efficacy of brief DBT-informed skills group in individuals with psychosis, with participants reporting high satisfaction and improvements in understanding and managing emotions, suicidality, and interpersonal functioning. However, this literature remains preliminary and underdeveloped, and no studies have evaluated group DBT skills intervention specifically for individuals with first-episode psychosis.
Aim 1: To evaluate the acceptability of the group DBT skills training invention and the feasibility of conducting a fully powered randomized controlled trial (RCT) of in young men with psychosis.
Aim 2: To assess the preliminary efficacy of group DBT skills training in improving emotion regulation, resilience, and functioning and reducing, mood and anxiety and substance use, in a single-arm exploratory clinical trial.
This study will provide evidence of the feasibility, acceptability, and preliminary efficacy of a group DBT skills training for young men with first-episode psychosis. Findings will advance understanding of emotion regulation as a treatment target in psychosis and inform the development of larger controlled trials evaluating emotion-focused interventions in early psychosis care. The intervention could represent a scalable and practical psychosocial treatment to address emotional difficulties that are common but often under-treated in psychosis.
This study employing qualitative and quantitative methods to evaluate the group DBT skills training intervention and test its feasibility, and acceptability in individuals with psychosis. A single arm trial where DBT skills group delivered over 8-weeks, will be conducted. Thirty-two participants are planned to be enrolled in the trial. Participants will continue with their standard outpatient care during the trial. Outcome measures will be completed at study entry and post-treatment. For the qualitative component of the study, 15 post-intervention semi-structured interviews will be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group DBT | Experimental | Behavioral: group DBTReceive 8-week Group DBT intervention |
Who may qualify
- Ages
- 14 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Be 14-35 years old.
- All gender identities are eligible to participate.
- Being competent as demonstrated by comprehension of the study procedures, risks, benefits and their rights as a volunteer in the research study and willing to consent to study participation.
- Meets criteria for a psychotic spectrum disorder as determined by Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (e.g., schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, delusional disorder, other specified schizophrenia spectrum disorder, or other unspecified schizophrenia spectrum disorder), or bipolar disorder with psychotic features, and is within 3 years of their initial diagnosis.
Key exclusion criteria (3 listed)
- Diagnosis of intellectual disability previously documented in the patient chart.
- Acute suicidality requiring immediate life-saving intervention (i.e., inpatient psychiatric care).
- Receiving any additional structured psychotherapy interventions during the study period.
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 |
|---|---|---|
| group DBTDBT skills group delivered over 8-weeks | Behavioural | Group DBT |
Primary outcome
Adherence
Time frame: post treatment (8 weeks after baseline)
Percent sessions attended
Retention rates
Time frame: post treatment (8 weeks after baseline)
Percent participants who complete 8-week study.
Attrition
Time frame: post treatment (8 weeks after baseline)
Percent participants that dropout at 8 weeks
Client Satisfaction Questionnaire
Time frame: post treatment (8 weeks after baseline)
A Likert scale from 1-4, total scores range from 8-32, with higher scores indicating greater satisfaction.
Timeline Follow Back (TLFB)
Time frame: From enrollment to the end of treatment at 8 weeks
A self-report method for substance use, and will be used to quantify the amount/frequency of cannabis in the past 14 days.
11 secondary outcomes
Brief Psychiatric Rating Scale (BPRS)
Time frame: From enrollment to the end of treatment at 8 weeks
Scale for the Assessment of Negative Symptoms (SANS)
Time frame: From enrollment to the end of treatment at 8 weeks
Calgary Depression Scale for Schizophrenia (CDSS)
Time frame: From enrollment to the end of treatment at 8 weeks
State-Trait Anxiety Inventory (STAI)
Time frame: From enrollment to the end of treatment at 8 weeks
Borderline Symptom List (BSL-23)
Time frame: From enrollment to the end of treatment at 8 weeks
Difficulties in emotion regulation scale (DERS)
Time frame: From enrollment to the end of treatment at 8 weeks
Global Functioning: Social and Role Scales
Time frame: From enrollment to the end of treatment at 8 weeks
Connor-Davidson Resilience Scale (CD-RISC)
Time frame: From enrollment to the end of treatment at 8 weeks
Adolescent Alcohol and Drug Involvement Scale (AADIS)
Time frame: From enrollment to the end of treatment at 8 weeks
Cannabis Use Disorders Identification Test-Revised (CUDIT-R)
Time frame: From enrollment to the end of treatment at 8 weeks
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing group DBT in people with Psychosis, run by Centre for Addiction and Mental Health.
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: opening soon, as of the sponsor's last update on 16 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omair Husain (416-535-8501 ext. 36467, omair.husain@camh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (time frame: post treatment (8 weeks after baseline)). The study lists 5 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 16 Sep 2026.