Clinical trial NCT05100875: Social Skills and Emotion Regulation Training "SSERT" for Trauma in Psychosis
Official title: Social Skills and Emotion Regulation Training "SSERT" for Trauma in Psychosis: A Pilot Feasibility and Acceptability Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychosis
Trauma
Emotion Regulation
Lead sponsor: Douglas Mental Health University Institute
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Participant completion rate
timeFrame: 10 weeks of the intervention
measure: Adverse events
timeFrame: 10 weeks of the intervention
measure: SSERT Feasibility Questionnaire-Therapist
timeFrame: Completion time 10 minutes
measure: Working Alliance Inventory-Short Revised
timeFrame: Completion time 5 minutes
measure: Client Motivation for Therapy Scale
timeFrame: Completion time 5 minutes
measure: Client Satisfaction Questionnaire
timeFrame: Completion time 5 minutes
measure: The Satisfaction with Therapy Questionnaire
timeFrame: Completion time 5 minutes
Secondary outcomes:
measure: Emotion Regulation Skills Questionnaire
timeFrame: Completion time 5 minutes
measure: Inventory of Interpersonal Problems- 32
timeFrame: Completion time 5 minutes
Other outcomes:
measure: The PTSD Checklist for DSM-5
timeFrame: Completion time 10 minutes
measure: The Dissociative Experiences Scale II
timeFrame: Completion time 10 minutes
measure: Positive and Negative Syndrome Scale-6 (PANSS-6)
timeFrame: Evaluation time 20 minutes
measure: Psychotic Symptoms Rating Scales, distress dimension
timeFrame: Evaluation time 10 minutes
measure: Beck Cognitive Insight Scale
timeFrame: Completion time 5 minutes
measure: Overall Anxiety and Severity Impairment Scale
timeFrame: Completion time 5 minutes
measure: Patient Health Questionnaire-9
timeFrame: Completion time 5 minutes
measure: Brief COPE scale
timeFrame: Completion time 5 minutes
measure: Abbreviated- Quality of Life Enjoyment and Satisfaction Questionnaire
timeFrame: Completion time 5 minutes
measure: Self-Esteem Rating Scale- Short Form
timeFrame: Completion time 5 minutes
measure: The Warwick-Edinburgh Mental Well-being Scale
timeFrame: Completion time 5 minutes
Locations:
city: Verdun
country: Canada
facility: Douglas Research Center
state: Quebec
Study officials:
References: