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

Sponsor

Helsinki University Central Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05802758

Collaborator

(none)

144

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Compassion-focused Short Intervention and Training in Virtual Reality Among Youngsters With Conduct Problems and Psychopathic Traits	Behavioral: Psychopathy.comp and training in virtual reality (VR)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

144 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Sep 30, 2028

Anticipated Study Completion Date :

Dec 31, 2029

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

The self-reported change in Youth Pysychopathic traits Inventory- short version (YPI-S) and in the factors of it [5 months]
Measures both conduct prolems and psychopathic traits

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 20 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

15-20 year-old males, who express conduct disorder psychopatology and who 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	State Residential Schools	Helsinki		Finland	00271
2	Prison and Probation Service of Finland	Helsinki		Finland	00530

Sponsors and Collaborators

Helsinki University Central Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nina Lindberg, senior doctor, professor, Helsinki University Central Hospital

ClinicalTrials.gov Identifier:

NCT05802758

Other Study ID Numbers:

HUS/345/2023

First Posted:

Apr 7, 2023

Last Update Posted:

Apr 7, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nina Lindberg, senior doctor, professor, Helsinki University Central Hospital

compassion-focused therapy, virtual reality, youngster, conduct disorder

Study Results

No Results Posted as of Apr 7, 2023