Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06606002
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
The Effectiveness of Group Schema Therapy in the Treatment of Borderline Symptoms in Adolescents
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effectiveness of Group Schema Therapy Utilizing Video Material in the Treatment of Borderline Symptoms in Adolescents a Randomized and Controlled Intervention Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this randomized and controlled trial is to assess the effectiveness of group schema therapy in the treatment of adolescents with borderline symptoms The intervention utilizes self-recorded video material as an experiential method The intervention comprises 30 group sessions and 8 individual sessions Additionally there are group sessions for the participants parents Participants in the control group receive treatment as usual
Detailed Description:
The goal of this randomized and controlled intervention study is to assess the effectiveness of group schema therapy in the treatment of adolescents with borderline symptoms Borderline personality disorder BPD is a severe and chronic mental health disorder which features are typically detectable already in adolescence BPD causes considerable suffering and functional impairment Treatment recommendations emphasize treating BPD with targeted interventions already in adolescence but evidence-based treatments in this age group are so far scarce
The research sample consists of 32 adolescents who participate in a group schema therapy intervention and their 32 controls The participants are adolescents aged 15-18 who are being treated at the Adolescent Psychiatry Clinic at the Turku University Hospital The subjects meet at least three diagnostic criteria for BPD based on SCID-II assessment Adolescents who are at serious suicide risk or with for example psychotic symptoms or another disorder or symptom that endangers commitment to the intervention protocol are excluded from the study
The studied intervention is based on Farrell and Shaws group schema therapy model The experiential part of the model is strengthened utilizing videos which are recorded by the participants VideoTalk The videos are used to support both individual and group work The intervention is tailored to be developmentally sensitive for this age group and reinforced with a module to which the participants parents participate
The intervention comprises 30 weekly group sessions and 8 individual sessions Eight adolescents participate in one group and four groups are carried out during the study The participants parents have 9 group sessions some of which the adolescents also participate in The duration of the intervention is approximately one year The control group receives treatment as usual
Both the intervention and control groups response to the research questionnaires at five time points baseline 3 months 6 months 12 months 2 years The primary response variable is the change in the BPD symptoms between entering the study and the end of the intervention As secondary response variables changes in for example the participants early maladaptive schemas schema modes and depressive and anxiety symptoms are assessed After the end of the intervention the study includes a one-year follow-up period and two years after the intervention follow-up data is collected from the participants medical reports The study also includes qualitative sub-studies
The intervention groups will be carried out during the years 2025-2027 A new group is always started overlapping with the previous group Results regarding the primary response variable will be completed at the end of 2027 The entire research material will be completed at the end of 2029
The research sample consists of 32 adolescents who participate in a group schema therapy intervention and their 32 controls The participants are adolescents aged 15-18 who are being treated at the Adolescent Psychiatry Clinic at the Turku University Hospital The subjects meet at least three diagnostic criteria for BPD based on SCID-II assessment Adolescents who are at serious suicide risk or with for example psychotic symptoms or another disorder or symptom that endangers commitment to the intervention protocol are excluded from the study
The studied intervention is based on Farrell and Shaws group schema therapy model The experiential part of the model is strengthened utilizing videos which are recorded by the participants VideoTalk The videos are used to support both individual and group work The intervention is tailored to be developmentally sensitive for this age group and reinforced with a module to which the participants parents participate
The intervention comprises 30 weekly group sessions and 8 individual sessions Eight adolescents participate in one group and four groups are carried out during the study The participants parents have 9 group sessions some of which the adolescents also participate in The duration of the intervention is approximately one year The control group receives treatment as usual
Both the intervention and control groups response to the research questionnaires at five time points baseline 3 months 6 months 12 months 2 years The primary response variable is the change in the BPD symptoms between entering the study and the end of the intervention As secondary response variables changes in for example the participants early maladaptive schemas schema modes and depressive and anxiety symptoms are assessed After the end of the intervention the study includes a one-year follow-up period and two years after the intervention follow-up data is collected from the participants medical reports The study also includes qualitative sub-studies
The intervention groups will be carried out during the years 2025-2027 A new group is always started overlapping with the previous group Results regarding the primary response variable will be completed at the end of 2027 The entire research material will be completed at the end of 2029
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None