Douglas Research Center
Verdun, Quebec, H4H 1R3, Canada
NCT Number: NCT05100875
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Verdun, Quebec, H4H 1R3, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 10 weeks of the intervention
Feasibility, percentage of participants to complete at least 50% of sessions
Time frame: 10 weeks of the intervention
Feasibility, number of recorded adverse events directly associated with the trial
Time frame: Completion time 10 minutes
Feasibility, self-report questionnaire completed by the therapist
Time frame: Completion time 5 minutes
Acceptability, self-report questionnaire
Time frame: Completion time 5 minutes
Acceptability, self-report questionnaire
Time frame: Completion time 5 minutes
Acceptability/satisfaction, self-report questionnaire
Time frame: Completion time 5 minutes
Acceptability/satisfaction, self-report questionnaire
Time frame: Completion time 5 minutes
Emotion regulation, self-report questionnaire
Time frame: Completion time 5 minutes
Interpersonal functioning, self-report questionnaire
Time frame: Completion time 10 minutes
Posttraumatic stress symptoms, self-report questionnaire
Time frame: Completion time 10 minutes
Dissociative symptoms, self-report questionnaire
Time frame: Evaluation time 20 minutes
Psychotic symptoms, observer-rated measure
Time frame: Evaluation time 10 minutes
Distress associated with psychotic symptoms, observer-rated measure
Time frame: Completion time 5 minutes
Metacognition, self-report questionnaire
Time frame: Completion time 5 minutes
Anxiety, self-report questionnaire
Time frame: Completion time 5 minutes
Depression, self-report questionnaire
Time frame: Completion time 5 minutes
Coping, self-report questionnaire
Time frame: Completion time 5 minutes
Quality of life, self-report questionnaire
Time frame: Completion time 5 minutes
Self-esteem, self-report questionnaire
Time frame: Completion time 5 minutes
Wellbeing, self-report questionnaire
Douglas Mental Health University Institute
Other
Social Skills and Emotion Regulation Training "SSERT" for Trauma in Psychosis: A Pilot Feasibility and Acceptability Study
Acronym: SSERT
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