Psychosis
Conditions
Keywords
Psychosis, DBT, Group therapy
Brief 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. 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.
Interventions
BEHAVIORALgroup DBT
DBT skills group delivered over 8-weeks
Sponsors
Centre for Addiction and Mental Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
1. Be 14-35 years old. 2. All gender identities are eligible to participate. 3. 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. 4. 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.
Exclusion criteria
1. Diagnosis of intellectual disability previously documented in the patient chart. 2. Acute suicidality requiring immediate life-saving intervention (i.e., inpatient psychiatric care). 3. Receiving any additional structured psychotherapy interventions during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence | post treatment (8 weeks after baseline) | Percent sessions attended |
| Retention rates | post treatment (8 weeks after baseline) | Percent participants who complete 8-week study. |
| Attrition | post treatment (8 weeks after baseline) | Percent participants that dropout at 8 weeks |
| Client Satisfaction Questionnaire | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brief Psychiatric Rating Scale (BPRS) | From enrollment to the end of treatment at 8 weeks | 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. |
| Scale for the Assessment of Negative Symptoms (SANS) | From enrollment to the end of treatment at 8 weeks | 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. |
| Calgary Depression Scale for Schizophrenia (CDSS) | From enrollment to the end of treatment at 8 weeks | 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. |
| State-Trait Anxiety Inventory (STAI) | From enrollment to the end of treatment at 8 weeks | 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. |
| Borderline Symptom List (BSL-23) | From enrollment to the end of treatment at 8 weeks | 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. |
| Difficulties in emotion regulation scale (DERS) | From enrollment to the end of treatment at 8 weeks | 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. |
| Global Functioning: Social and Role Scales | From enrollment to the end of treatment at 8 weeks | 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. |
| Connor-Davidson Resilience Scale (CD-RISC) | From enrollment to the end of treatment at 8 weeks | 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. |
| Adolescent Alcohol and Drug Involvement Scale (AADIS) | From enrollment to the end of treatment at 8 weeks | 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. |
| Cannabis Use Disorders Identification Test-Revised (CUDIT-R) | From enrollment to the end of treatment at 8 weeks | 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 |
| Columbia-Suicide Severity Rating Scale (C-SSRS) | From enrollment to the end of treatment at 8 weeks | 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 |
Contacts
CONTACTOmair Husain
Outcome results
None listed