Social Skills and Emotion Regulation Training "SSERT" for Trauma in Psychosis

NCT05100875 | Completed

• 1 other identifier: SSERT
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate if the SSERT (Social Skills and Emotion Regulation Training) intervention is feasible and acceptable in individual with psychotic disorder and a history of trauma.

Conditions

Psychosis; Trauma; Emotion Regulation

Outcome Measures

Primary Outcomes (7)

• Participant completion rate

  Feasibility, percentage of participants to complete at least 50% of sessions

  10 weeks of the intervention

• Adverse events

  Feasibility, number of recorded adverse events directly associated with the trial

  10 weeks of the intervention

• SSERT Feasibility Questionnaire-Therapist

  Feasibility, self-report questionnaire completed by the therapist

  Completion time 10 minutes

• Working Alliance Inventory-Short Revised

  Acceptability, self-report questionnaire

  Completion time 5 minutes

• Client Motivation for Therapy Scale

  Acceptability, self-report questionnaire

  Completion time 5 minutes

• Client Satisfaction Questionnaire

  Acceptability/satisfaction, self-report questionnaire

  Completion time 5 minutes

• The Satisfaction with Therapy Questionnaire

  Acceptability/satisfaction, self-report questionnaire

  Completion time 5 minutes

Secondary Outcomes (2)

• Emotion Regulation Skills Questionnaire

  Completion time 5 minutes

• Inventory of Interpersonal Problems- 32

  Completion time 5 minutes

Other Outcomes (11)

• The PTSD Checklist for DSM-5

  Completion time 10 minutes

• The Dissociative Experiences Scale II

  Completion time 10 minutes

• Positive and Negative Syndrome Scale-6 (PANSS-6)

  Evaluation time 20 minutes

Study Arms (1)

Intervention SSERT

EXPERIMENTAL

The SSERT intervention will take place over 10 weekly individual intervention sessions of 60 minutes. SSERT for trauma history in psychosis will draw inspiration from the Skills Training in Affective and Interpersonal Regulation intervention as well as other CBT and DBT-based interventions for emotion regulation and social skills functioning. Therapists will be provided with a semi-structured manual that can be implemented flexibly to consider participant needs.

Behavioral: Social Skills and Emotion Regulation Training "SSERT"

Interventions

Social Skills and Emotion Regulation Training "SSERT" BEHAVIORAL

The SSERT intervention will broadly consist of the following 10 modules: (1) Introducing the Participant to Treatment; (2-3) Emotional Awareness and Recognition; (4-5) Emotion Regulation and Understanding Emotions in the Context of Psychotic Experiences; (6) Living an Emotionally Engaged Life; (7) Understanding Relationship Patterns in the Context of Psychosis; (8) Changing Undesirable Relationship Patterns; (9) Learning to have agency in Relationships; and (10) Flexibility in Relationships and Transitioning to Trauma-Focused Therapy.

Intervention SSERT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) diagnosis of a schizophrenia spectrum or other psychotic disorder including affective psychosis;
• (2) trauma history meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-5) PTSD criterion A;
• (3) at least a mild impairment in either emotional regulation or interpersonal functioning, identified using predetermined cut-offs of ≤ 2 on the Emotion Regulation Skills Questionnaire or ≥ 1 on the Inventory or Interpersonal Problems-32 ;
• (4) at least 18 years of age;
• (5) clinically stable/taking a stable dose of antipsychotic medication;
• (6) French or English-speaking; and
• (7) with no major physical illness.

You may not qualify if:

• (1) history of a medical or neurological condition that can affect cognition, which will be verified via participant self-report;
• (2) current severe substance use disorder; and
• (3) an IQ score below 70, estimated using the Wechsler Abbreviated Scale of Intelligence - Two subtest version (vocabulary, matrix reasoning)

Sponsors & Collaborators

• Douglas Mental Health University Institute: lead

Study Sites (1)

Douglas Research Center

Verdun, Quebec, H4H 1R3, Canada

Location

MeSH Terms

Conditions

Psychotic Disorders; Wounds and Injuries; Emotional Regulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: October 29, 2021
• Study Start: July 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)