PsychosisSSERTNCT05100875
Social Skills and Emotion Regulation Training "SSERT" for Trauma in Psychosis
A study testing Social Skills and Emotion Regulation Training "SSERT" in people with Psychosis and Trauma, run by Douglas Mental Health University Institute at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychosis, Trauma, Emotion Regulation
- What is being tested?
- Social Skills and Emotion Regulation Training "SSERT"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2021to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Social Skills and Emotion Regulation Training "SSERT" for Trauma in Psychosis: A Pilot Feasibility and Acceptability Study
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.
Read the 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.
- Conditions
- Psychosis, Trauma, Emotion Regulation
- Being tested
- Social Skills and Emotion Regulation Training "SSERT"
- Medical subject headings
- Psychotic Disorders, Wounds and Injuries, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Skills and Emotion Regulation Training "SSERT"Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention SSERT | Experimental | The SSERT intervention will take place over 10 weekly individual intervention sessions of 60 minutes. SSERT for trauma history in psychosis will draw inspiration from the Skills Training in Affective and Interpersonal Regulation intervention as well as other CBT and DBT-based interventions for emotion regulation and social skills functioning. Therapists will be provided with a semi-structured manual that can be implemented flexibly to consider participant needs. Receives: Behavioral: Social Skills and Emotion Regulation Training "SSERT" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant completion rate
Feasibility, percentage of participants to complete at least 50% of sessions
Measured: 10 weeks of the intervention
Adverse events
Feasibility, number of recorded adverse events directly associated with the trial
Measured: 10 weeks of the intervention
SSERT Feasibility Questionnaire-Therapist
Feasibility, self-report questionnaire completed by the therapist
Measured: Completion time 10 minutes
Working Alliance Inventory-Short Revised
Acceptability, self-report questionnaire
Measured: Completion time 5 minutes
Client Motivation for Therapy Scale
Acceptability, self-report questionnaire
Measured: Completion time 5 minutes
Client Satisfaction Questionnaire
Acceptability/satisfaction, self-report questionnaire
Measured: Completion time 5 minutes
The Satisfaction with Therapy Questionnaire
Acceptability/satisfaction, self-report questionnaire
Measured: Completion time 5 minutes
Secondary outcomes (2)
Emotion Regulation Skills Questionnaire
Emotion regulation, self-report questionnaire
Measured: Completion time 5 minutes
Inventory of Interpersonal Problems- 32
Interpersonal functioning, self-report questionnaire
Measured: Completion time 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start1 Jul 2021
- Primary completion31 Dec 2023
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Douglas Mental Health University Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Lepage, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100875
- Sponsor's protocol ID
- SSERT
- Acronym
- SSERT
- Status last verified
- Aug 2024
- First submitted
- 26 Jul 2021
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Skills and Emotion Regulation Training "SSERT" for Trauma in Psychosis: A Pilot Feasibility and Acceptability Study
- ClinicalTrials.gov ID
- NCT05100875
- Acronym / sponsor ID
- SSERT / SSERT
- Conditions
- Psychosis, Trauma, Emotion Regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Douglas Mental Health University InstituteUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention SSERT | Experimental | Behavioral: Social Skills and Emotion Regulation Training "SSERT"The SSERT intervention will take place over 10 weekly individual intervention sessions of 60 minutes. SSERT for trauma history in psychosis will draw inspiration from the Skills Training in Affective and Interpersonal Regulation intervention as well as other CBT and DBT-based interventions for emotion regulation and social skills functioning. Therapists will be provided with a semi-structured manual that can be implemented flexibly to consider participant needs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- (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;
Key exclusion criteria (3 listed)
- (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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention SSERT |
Primary outcome
Participant completion rate
Time frame: 10 weeks of the intervention
Feasibility, percentage of participants to complete at least 50% of sessions
Adverse events
Time frame: 10 weeks of the intervention
Feasibility, number of recorded adverse events directly associated with the trial
SSERT Feasibility Questionnaire-Therapist
Time frame: Completion time 10 minutes
Feasibility, self-report questionnaire completed by the therapist
Working Alliance Inventory-Short Revised
Time frame: Completion time 5 minutes
Acceptability, self-report questionnaire
Client Motivation for Therapy Scale
Time frame: Completion time 5 minutes
Acceptability, self-report questionnaire
Client Satisfaction Questionnaire
Time frame: Completion time 5 minutes
Acceptability/satisfaction, self-report questionnaire
The Satisfaction with Therapy Questionnaire
Time frame: Completion time 5 minutes
Acceptability/satisfaction, self-report questionnaire
2 secondary outcomes
Emotion Regulation Skills Questionnaire
Time frame: Completion time 5 minutes
Inventory of Interpersonal Problems- 32
Time frame: Completion time 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Skills and Emotion Regulation Training "SSERT" in people with Psychosis and Trauma, run by Douglas Mental Health University Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant completion rate (time frame: 10 weeks of the intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.