Back to resultsCFT-focused Mental Health Intervention With Exposure Training for Youngsters (CFT+VR)
Primary Purpose
Conduct Disorder, Psychopathic Personality Trait
Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Psychopathy.comp and training in virtual reality (VR)
Sponsored by
About this trial
This is an interventional treatment trial for Conduct Disorder focused on measuring psychotherapy, virtual reality, boys
Eligibility Criteria
Inclusion Criteria: Express conduct disorder psychopathology and psychopathic personality traits Are placed to a prison or a state residential school for at least 9 months Exclusion Criteria: Females Non-Finninsh-speaking Remaining in the institution facility less than 9 months Intellectual dissability Presence of psychotic symptoms Autism History of epilepsy Currently participating another psychotherapeutic intervention
Sites / Locations
- State Residential SchoolsRecruiting
- Prison and Probation Service of FinlandRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Youngsters who get CFT + VR
Treatment as usual
Arm Description
yougsters, who get compassion-focused short intervention together with training in virtual reality together with general psychosocial rehabilitation offered by prisons and state residential schools
youngsters, who get only general psychosocial rehabilitation offered by prisons and state residential schools
Outcomes
Primary Outcome Measures
The self-reported change in Youth Pysychopathic traits Inventory- short version (YPI-S) and in the factors of it
Measures both conduct prolems and psychopathic traits
Secondary Outcome Measures
Short Warwick-Edinburgh Wellbeing scale (SWEMWBS)
measures general psychosocial well-being
Difficulties in Emotion Regulating Scale-Short form (DERS-SF)
measures emotion regulation style
WHO's quality of life questionnaire- Brief version (WHOQOL-BREF)
measures quality of life
Self-Compassion Scale- Short Form (SCS-SF)
measures self-compassion
Santa Clara Compassion Scale
masures compassion against other people
Young Person's Clinical Outcomes in Routine Evaluation (YP-CORE)
measures how the intervention is felt by the youngster
Situational intrinsic and extrinsic motivation scale (SIMS)
measures younster's motivation to participate the intervention
Toronto Alexitymia Scale (TAS-20)
measures aleksitymia
The Personal Feelings Questionnaire- brief version (PFQ-2 Brief)
measures feelings of quilt
Full Information
NCT ID
NCT05802758
First Posted
March 25, 2023
Last Updated
July 30, 2023
Sponsor
Helsinki University Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05802758
Brief Title
CFT-focused Mental Health Intervention With Exposure Training for Youngsters
Acronym
CFT+VR
Official Title
Compassion-focused Mental Health Intervention With Exposure Training in Virtual Reality for Youngsters Living in an Institution
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
September 30, 2028 (Anticipated)
Study Completion Date
December 31, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to explore if individual CFT-based intervention with exposure training in virtual reality decreases conduct disorder symptoms and callous-unemoitonal traits , as well as increases subjective emotional welbeing among 15-to-20 year-old male prisoners and boys placed to state's residential schools. We will also study factors that may predict adherence to the intervention. These factors include mental well-being, motivation, and working alliance. In addition, we will evaluate the costs of the program.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conduct Disorder, Psychopathic Personality Trait
Keywords
psychotherapy, virtual reality, boys
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Youngsters who get CFT + VR
Arm Type
Active Comparator
Arm Description
yougsters, who get compassion-focused short intervention together with training in virtual reality together with general psychosocial rehabilitation offered by prisons and state residential schools
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
youngsters, who get only general psychosocial rehabilitation offered by prisons and state residential schools
Intervention Type
Behavioral
Intervention Name(s)
Psychopathy.comp and training in virtual reality (VR)
Intervention Description
Psychopathy.comp is a CFT-based manualized program of 20 sessions a 60 min, on a weekly basis. During the CFT-intervention, partipants try out their new skills in a tailored VR setting (x5)
Primary Outcome Measure Information:
Title
The self-reported change in Youth Pysychopathic traits Inventory- short version (YPI-S) and in the factors of it
Description
Measures both conduct prolems and psychopathic traits
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Short Warwick-Edinburgh Wellbeing scale (SWEMWBS)
Description
measures general psychosocial well-being
Time Frame
5months
Title
Difficulties in Emotion Regulating Scale-Short form (DERS-SF)
Description
measures emotion regulation style
Time Frame
5 months
Title
WHO's quality of life questionnaire- Brief version (WHOQOL-BREF)
Description
measures quality of life
Time Frame
5 months
Title
Self-Compassion Scale- Short Form (SCS-SF)
Description
measures self-compassion
Time Frame
5 months
Title
Santa Clara Compassion Scale
Description
masures compassion against other people
Time Frame
5 months
Title
Young Person's Clinical Outcomes in Routine Evaluation (YP-CORE)
Description
measures how the intervention is felt by the youngster
Time Frame
5 months
Title
Situational intrinsic and extrinsic motivation scale (SIMS)
Description
measures younster's motivation to participate the intervention
Time Frame
5 months
Title
Toronto Alexitymia Scale (TAS-20)
Description
measures aleksitymia
Time Frame
5 months
Title
The Personal Feelings Questionnaire- brief version (PFQ-2 Brief)
Description
measures feelings of quilt
Time Frame
5 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Express conduct disorder psychopathology and psychopathic personality traits
Are placed to a prison or a state residential school for at least 9 months
Exclusion Criteria:
Females
Non-Finninsh-speaking
Remaining in the institution facility less than 9 months
Intellectual dissability
Presence of psychotic symptoms
Autism
History of epilepsy
Currently participating another psychotherapeutic intervention
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nina Lindberg, PhD
Phone
+358504270028
Email
nina.lindberg@hus.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nina Lindberg, PhD
Organizational Affiliation
University of Helsinki
Official's Role
Principal Investigator
Facility Information:
Facility Name
State Residential Schools
City
Helsinki
ZIP/Postal Code
00271
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marko Manninen, PhD
Phone
+358405605090
Email
marko.manninen@thl.fi
First Name & Middle Initial & Last Name & Degree
Mirva Heikkilä, MSc
Facility Name
Prison and Probation Service of Finland
City
Helsinki
ZIP/Postal Code
00530
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nina Lindberg
Phone
+358504270028
Email
nina.lindberg@hus.fi
First Name & Middle Initial & Last Name & Degree
Jenni Kaunomäki, MSc
12. IPD Sharing Statement
Plan to Share IPD
No
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CFT-focused Mental Health Intervention With Exposure Training for Youngsters
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