Social Skills and Emotion Regulation Training "SSERT" for Trauma in Psychosis (SSERT)
Primary Purpose
Psychosis, Trauma, Emotion Regulation
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Social Skills and Emotion Regulation Training "SSERT"
Sponsored by
About this trial
This is an interventional supportive care trial for Psychosis
Eligibility Criteria
Inclusion Criteria:
- (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.
Exclusion Criteria:
- (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)
Sites / Locations
- Douglas Research CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention SSERT
Arm Description
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.
Outcomes
Primary Outcome Measures
Participant completion rate
Feasibility, percentage of participants to complete at least 50% of sessions
Adverse events
Feasibility, number of recorded adverse events directly associated with the trial
SSERT Feasibility Questionnaire-Therapist
Feasibility, self-report questionnaire completed by the therapist
Working Alliance Inventory-Short Revised
Acceptability, self-report questionnaire
Client Motivation for Therapy Scale
Acceptability, self-report questionnaire
Client Satisfaction Questionnaire
Acceptability/satisfaction, self-report questionnaire
The Satisfaction with Therapy Questionnaire
Acceptability/satisfaction, self-report questionnaire
Secondary Outcome Measures
Emotion Regulation Skills Questionnaire
Emotion regulation, self-report questionnaire
Inventory of Interpersonal Problems- 32
Interpersonal functioning, self-report questionnaire
Full Information
NCT ID
NCT05100875
First Posted
July 26, 2021
Last Updated
October 21, 2022
Sponsor
Douglas Mental Health University Institute
1. Study Identification
Unique Protocol Identification Number
NCT05100875
Brief Title
Social Skills and Emotion Regulation Training "SSERT" for Trauma in Psychosis
Acronym
SSERT
Official Title
Social Skills and Emotion Regulation Training "SSERT" for Trauma in Psychosis: A Pilot Feasibility and Acceptability Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Douglas Mental Health University Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Many individuals with psychotic disorders experience poor functional outcomes such as lower quality of life, lower levels of education, and lower life expectancy. Comorbid mental disorders, such as posttraumatic stress disorder and related posttraumatic stress symptoms tend to aggravate psychotic symptoms and, as a result, worsen functional outcomes. Further, emotion regulation and interpersonal functioning are generally impaired in individuals with psychotic disorders and histories of childhood trauma, and preliminary evidence suggests that these impairments may mediate the relationship between childhood trauma and psychotic symptom severity. Despite the high levels of trauma observed in psychotic populations, the last decade has seen only a modest increase in the number of trials examining the efficacy of trauma interventions in this population. Further, given the initial distress, destabilization, and increased vulnerability that may occur when first engaging in trauma-focused intervention, it has been argued that in those with psychotic disorders, stabilizing/grounding interventions may be a necessary fist step prior to engagement in trauma therapy. This study will thus assess whether the Social Skills and Emotion Regulation Training (SSERT) for Trauma in Psychosis is feasible and acceptable to offer as a preparatory intervention, and will examine its preliminary effect on emotion regulation, interpersonal functioning, and other functional outcomes. SSERT proposes a single-arm baseline with post-intervention design. We will recruit 20 participants with a psychotic disorder, a history of trauma, and an impairment in interpersonal functioning and/or emotion regulation. The intervention will consist of nine weekly hour-long individual sessions and one final 90-minute session. The feasibility of SSERT will be assessed by examining the profile or safety of the study (including whether there are any adverse events reported), the participant flow (missed sessions, attrition rates, retention/completion rates), and through both standardized and qualitative items assessing therapist feedback. The acceptability of SSERT will be assessed subjectively, specifically though participant responses on therapy satisfaction, therapeutic alliance, and motivation for therapy questionnaires. Qualitative analyses will identify common themes and assess participant comments. We expect that SSERT will be both feasible and acceptable to administer to this population. Any expectations regarding the intervention's effect in improving emotion regulation, interpersonal functioning, and other functional outcomes is exploratory. Overall, SSERT may help people with psychotic disorders to better understand how the experience and effect of trauma impacts their relationships and emotion management. The intervention may also help to improve functional outcomes and relationship quality by teaching emotion regulation and grounding strategies, and through learning to become more engaged and flexible in relationships.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis, Trauma, Emotion Regulation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention SSERT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Social Skills and Emotion Regulation Training "SSERT"
Intervention Description
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.
Primary Outcome Measure Information:
Title
Participant completion rate
Description
Feasibility, percentage of participants to complete at least 50% of sessions
Time Frame
10 weeks of the intervention
Title
Adverse events
Description
Feasibility, number of recorded adverse events directly associated with the trial
Time Frame
10 weeks of the intervention
Title
SSERT Feasibility Questionnaire-Therapist
Description
Feasibility, self-report questionnaire completed by the therapist
Time Frame
Completion time 10 minutes
Title
Working Alliance Inventory-Short Revised
Description
Acceptability, self-report questionnaire
Time Frame
Completion time 5 minutes
Title
Client Motivation for Therapy Scale
Description
Acceptability, self-report questionnaire
Time Frame
Completion time 5 minutes
Title
Client Satisfaction Questionnaire
Description
Acceptability/satisfaction, self-report questionnaire
Time Frame
Completion time 5 minutes
Title
The Satisfaction with Therapy Questionnaire
Description
Acceptability/satisfaction, self-report questionnaire
Time Frame
Completion time 5 minutes
Secondary Outcome Measure Information:
Title
Emotion Regulation Skills Questionnaire
Description
Emotion regulation, self-report questionnaire
Time Frame
Completion time 5 minutes
Title
Inventory of Interpersonal Problems- 32
Description
Interpersonal functioning, self-report questionnaire
Time Frame
Completion time 5 minutes
Other Pre-specified Outcome Measures:
Title
The PTSD Checklist for DSM-5
Description
Posttraumatic stress symptoms, self-report questionnaire
Time Frame
Completion time 10 minutes
Title
The Dissociative Experiences Scale II
Description
Dissociative symptoms, self-report questionnaire
Time Frame
Completion time 10 minutes
Title
Positive and Negative Syndrome Scale-6 (PANSS-6)
Description
Psychotic symptoms, observer-rated measure
Time Frame
Evaluation time 20 minutes
Title
Psychotic Symptoms Rating Scales, distress dimension
Description
Distress associated with psychotic symptoms, observer-rated measure
Time Frame
Evaluation time 10 minutes
Title
Beck Cognitive Insight Scale
Description
Metacognition, self-report questionnaire
Time Frame
Completion time 5 minutes
Title
Overall Anxiety and Severity Impairment Scale
Description
Anxiety, self-report questionnaire
Time Frame
Completion time 5 minutes
Title
Patient Health Questionnaire-9
Description
Depression, self-report questionnaire
Time Frame
Completion time 5 minutes
Title
Brief COPE scale
Description
Coping, self-report questionnaire
Time Frame
Completion time 5 minutes
Title
Abbreviated- Quality of Life Enjoyment and Satisfaction Questionnaire
Description
Quality of life, self-report questionnaire
Time Frame
Completion time 5 minutes
Title
Self-Esteem Rating Scale- Short Form
Description
Self-esteem, self-report questionnaire
Time Frame
Completion time 5 minutes
Title
The Warwick-Edinburgh Mental Well-being Scale
Description
Wellbeing, self-report questionnaire
Time Frame
Completion time 5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
(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.
Exclusion Criteria:
(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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karyne Anselmo, MSc
Phone
514-761-6131
Ext
3296
Email
karyne.anselmo@douglas.mcgill.ca
Facility Information:
Facility Name
Douglas Research Center
City
Verdun
State/Province
Quebec
ZIP/Postal Code
H4H 1R3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karyne Anselmo, MSc
Phone
514-761-6131
Ext
3296
Email
karyne.anselmo@douglas.mcgill.ca
First Name & Middle Initial & Last Name & Degree
Martin Lepage, PhD
First Name & Middle Initial & Last Name & Degree
Ghassan El-Baalbaki, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Social Skills and Emotion Regulation Training "SSERT" for Trauma in Psychosis
We'll reach out to this number within 24 hrs