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Completed

NCT Number: NCT05100875

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Douglas Research Center

Verdun, Quebec, H4H 1R3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Social Skills and Emotion Regulation Training "SSERT"

Behavioral

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 outcomes

  1. Participant completion rate

    Time frame: 10 weeks of the intervention

    Feasibility, percentage of participants to complete at least 50% of sessions

  2. Adverse events

    Time frame: 10 weeks of the intervention

    Feasibility, number of recorded adverse events directly associated with the trial

  3. SSERT Feasibility Questionnaire-Therapist

    Time frame: Completion time 10 minutes

    Feasibility, self-report questionnaire completed by the therapist

  4. Working Alliance Inventory-Short Revised

    Time frame: Completion time 5 minutes

    Acceptability, self-report questionnaire

  5. Client Motivation for Therapy Scale

    Time frame: Completion time 5 minutes

    Acceptability, self-report questionnaire

  6. Client Satisfaction Questionnaire

    Time frame: Completion time 5 minutes

    Acceptability/satisfaction, self-report questionnaire

  7. The Satisfaction with Therapy Questionnaire

    Time frame: Completion time 5 minutes

    Acceptability/satisfaction, self-report questionnaire

Secondary outcomes

  1. Emotion Regulation Skills Questionnaire

    Time frame: Completion time 5 minutes

    Emotion regulation, self-report questionnaire

  2. Inventory of Interpersonal Problems- 32

    Time frame: Completion time 5 minutes

    Interpersonal functioning, self-report questionnaire

Other outcomes

  1. The PTSD Checklist for DSM-5

    Time frame: Completion time 10 minutes

    Posttraumatic stress symptoms, self-report questionnaire

  2. The Dissociative Experiences Scale II

    Time frame: Completion time 10 minutes

    Dissociative symptoms, self-report questionnaire

  3. Positive and Negative Syndrome Scale-6 (PANSS-6)

    Time frame: Evaluation time 20 minutes

    Psychotic symptoms, observer-rated measure

  4. Psychotic Symptoms Rating Scales, distress dimension

    Time frame: Evaluation time 10 minutes

    Distress associated with psychotic symptoms, observer-rated measure

  5. Beck Cognitive Insight Scale

    Time frame: Completion time 5 minutes

    Metacognition, self-report questionnaire

  6. Overall Anxiety and Severity Impairment Scale

    Time frame: Completion time 5 minutes

    Anxiety, self-report questionnaire

  7. Patient Health Questionnaire-9

    Time frame: Completion time 5 minutes

    Depression, self-report questionnaire

  8. Brief COPE scale

    Time frame: Completion time 5 minutes

    Coping, self-report questionnaire

  9. Abbreviated- Quality of Life Enjoyment and Satisfaction Questionnaire

    Time frame: Completion time 5 minutes

    Quality of life, self-report questionnaire

  10. Self-Esteem Rating Scale- Short Form

    Time frame: Completion time 5 minutes

    Self-esteem, self-report questionnaire

  11. The Warwick-Edinburgh Mental Well-being Scale

    Time frame: Completion time 5 minutes

    Wellbeing, self-report questionnaire

Sponsors and collaborators

Lead sponsor

Douglas Mental Health University Institute

Other

Registry information

Official study title

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

Acronym: SSERT

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Oct 29, 2021
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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