CFT-focused Mental Health Intervention With Exposure Training for Youngsters (CFT+VR)

Compassion-focused Mental Health Intervention With Exposure Training in Virtual Reality for Youngsters Living in an Institution

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.

Study Overview

• Status: Recruiting
• Conditions: Conduct Disorder; Psychopathic Personality Trait
• Intervention / Treatment: Behavioral: Psychopathy.comp and training in virtual reality (VR)

• Study Type: Interventional
• Enrollment (Estimated): 144
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nina Lindberg, PhD; Phone Number: +358504270028; Email: nina.lindberg@hus.fi

Study Locations

• Finland
  • Helsinki, Finland, 00271
    • Recruiting
    • State Residential Schools
    • Contact: Marko Manninen, PhD; Phone Number: +358405605090; Email: marko.manninen@thl.fi
    • Sub-Investigator: Mirva Heikkilä, MSc
  • Helsinki, Finland, 00530
    • Recruiting
    • Prison and Probation Service of Finland
    • Contact: Nina Lindberg; Phone Number: +358504270028; Email: nina.lindberg@hus.fi
    • Principal Investigator: Jenni Kaunomäki, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Youngsters who get CFT + VR; 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	Behavioral: Psychopathy.comp and training in virtual reality (VR); 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)
No Intervention: Treatment as usual; youngsters, who get only general psychosocial rehabilitation offered by prisons and state residential schools

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Warwick-Edinburgh Wellbeing scale (SWEMWBS)	measures general psychosocial well-being	5months
Difficulties in Emotion Regulating Scale-Short form (DERS-SF)	measures emotion regulation style	5 months
WHO's quality of life questionnaire- Brief version (WHOQOL-BREF)	measures quality of life	5 months
Self-Compassion Scale- Short Form (SCS-SF)	measures self-compassion	5 months
Santa Clara Compassion Scale	masures compassion against other people	5 months
Young Person's Clinical Outcomes in Routine Evaluation (YP-CORE)	measures how the intervention is felt by the youngster	5 months
Situational intrinsic and extrinsic motivation scale (SIMS)	measures younster's motivation to participate the intervention	5 months
Toronto Alexitymia Scale (TAS-20)	measures aleksitymia	5 months
The Personal Feelings Questionnaire- brief version (PFQ-2 Brief)	measures feelings of quilt	5 months

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Investigators: Principal Investigator: Nina Lindberg, PhD, University of Helsinki

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: March 25, 2023
• First Submitted That Met QC Criteria: March 25, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 30, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: psychotherapy, virtual reality, boys
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Antisocial Personality Disorder; Conduct Disorder
• Other Study ID Numbers: HUS/345/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No