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

Trauma Clinical Trial

— SSERT  

Official title:

Social Skills and Emotion Regulation Training "SSERT" for Trauma in Psychosis: A Pilot Feasibility and Acceptability Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05100875
• Other study ID #: SSERT
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: March 31, 2024

Study information

• Verified date: October 2023
• Source: Douglas Mental Health University Institute
• Contact: Karyne Anselmo, MSc
• Phone: 514-761-6131
• Email: karyne.anselmo[@]douglas.mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Emotion Regulation
• Mental Disorders
• Psychosis
• Psychotic Disorders
• Trauma
• Wounds and Injuries

Intervention

Behavioral:
• Social Skills and Emotion Regulation Training "SSERT"
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.

Locations

Country	Name	City	State
Canada	Douglas Research Center	Verdun	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Douglas Mental Health University Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The PTSD Checklist for DSM-5	Posttraumatic stress symptoms, self-report questionnaire	Completion time 10 minutes
Other	The Dissociative Experiences Scale II	Dissociative symptoms, self-report questionnaire	Completion time 10 minutes
Other	Positive and Negative Syndrome Scale-6 (PANSS-6)	Psychotic symptoms, observer-rated measure	Evaluation time 20 minutes
Other	Psychotic Symptoms Rating Scales, distress dimension	Distress associated with psychotic symptoms, observer-rated measure	Evaluation time 10 minutes
Other	Beck Cognitive Insight Scale	Metacognition, self-report questionnaire	Completion time 5 minutes
Other	Overall Anxiety and Severity Impairment Scale	Anxiety, self-report questionnaire	Completion time 5 minutes
Other	Patient Health Questionnaire-9	Depression, self-report questionnaire	Completion time 5 minutes
Other	Brief COPE scale	Coping, self-report questionnaire	Completion time 5 minutes
Other	Abbreviated- Quality of Life Enjoyment and Satisfaction Questionnaire	Quality of life, self-report questionnaire	Completion time 5 minutes
Other	Self-Esteem Rating Scale- Short Form	Self-esteem, self-report questionnaire	Completion time 5 minutes
Other	The Warwick-Edinburgh Mental Well-being Scale	Wellbeing, self-report questionnaire	Completion time 5 minutes
Primary	Participant completion rate	Feasibility, percentage of participants to complete at least 50% of sessions	10 weeks of the intervention
Primary	Adverse events	Feasibility, number of recorded adverse events directly associated with the trial	10 weeks of the intervention
Primary	SSERT Feasibility Questionnaire-Therapist	Feasibility, self-report questionnaire completed by the therapist	Completion time 10 minutes
Primary	Working Alliance Inventory-Short Revised	Acceptability, self-report questionnaire	Completion time 5 minutes
Primary	Client Motivation for Therapy Scale	Acceptability, self-report questionnaire	Completion time 5 minutes
Primary	Client Satisfaction Questionnaire	Acceptability/satisfaction, self-report questionnaire	Completion time 5 minutes
Primary	The Satisfaction with Therapy Questionnaire	Acceptability/satisfaction, self-report questionnaire	Completion time 5 minutes
Secondary	Emotion Regulation Skills Questionnaire	Emotion regulation, self-report questionnaire	Completion time 5 minutes
Secondary	Inventory of Interpersonal Problems- 32	Interpersonal functioning, self-report questionnaire	Completion time 5 minutes