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Social Skills and Emotion Regulation Training SSERT for Trauma in Psychosis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05100875
Acronym
SSERT
Enrollment
19
Registered
2021-10-29
Start date
2021-07-01
Completion date
2024-03-31
Last updated
2024-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emotion Regulation, Psychosis, Trauma

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.

Interventions

BEHAVIORALSocial 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.

Sponsors

Douglas Mental Health University Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
The Satisfaction with Therapy QuestionnaireCompletion time 5 minutesAcceptability/satisfaction, self-report questionnaire
Client Motivation for Therapy ScaleCompletion time 5 minutesAcceptability, self-report questionnaire
Client Satisfaction QuestionnaireCompletion time 5 minutesAcceptability/satisfaction, self-report questionnaire
Participant completion rate10 weeks of the interventionFeasibility, percentage of participants to complete at least 50% of sessions
Adverse events10 weeks of the interventionFeasibility, number of recorded adverse events directly associated with the trial
SSERT Feasibility Questionnaire-TherapistCompletion time 10 minutesFeasibility, self-report questionnaire completed by the therapist
Working Alliance Inventory-Short RevisedCompletion time 5 minutesAcceptability, self-report questionnaire

Secondary

MeasureTime frameDescription
Inventory of Interpersonal Problems- 32Completion time 5 minutesInterpersonal functioning, self-report questionnaire
Emotion Regulation Skills QuestionnaireCompletion time 5 minutesEmotion regulation, self-report questionnaire

Other

MeasureTime frameDescription
Self-Esteem Rating Scale- Short FormCompletion time 5 minutesSelf-esteem, self-report questionnaire
The PTSD Checklist for DSM-5Completion time 10 minutesPosttraumatic stress symptoms, self-report questionnaire
The Warwick-Edinburgh Mental Well-being ScaleCompletion time 5 minutesWellbeing, self-report questionnaire
The Dissociative Experiences Scale IICompletion time 10 minutesDissociative symptoms, self-report questionnaire
Positive and Negative Syndrome Scale-6 (PANSS-6)Evaluation time 20 minutesPsychotic symptoms, observer-rated measure
Psychotic Symptoms Rating Scales, distress dimensionEvaluation time 10 minutesDistress associated with psychotic symptoms, observer-rated measure
Beck Cognitive Insight ScaleCompletion time 5 minutesMetacognition, self-report questionnaire
Overall Anxiety and Severity Impairment ScaleCompletion time 5 minutesAnxiety, self-report questionnaire
Patient Health Questionnaire-9Completion time 5 minutesDepression, self-report questionnaire
Brief COPE scaleCompletion time 5 minutesCoping, self-report questionnaire
Abbreviated- Quality of Life Enjoyment and Satisfaction QuestionnaireCompletion time 5 minutesQuality of life, self-report questionnaire

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026