CFT-focused Mental Health Intervention With Exposure Training for Youngsters

Conduct Disorder Clinical Trial

— CFT+VR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05802758
• Other study ID #: HUS/345/2023
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2029

Study information

• Verified date: July 2023
• Source: Helsinki University Central Hospital
• Contact: Nina Lindberg, PhD
• Phone: +358504270028
• Email: nina.lindberg[@]hus.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: December 31, 2029
• Est. primary completion date: September 30, 2028
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 15 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Antisocial Personality Disorder
• Conduct Disorder
• Psychopathic Personality Trait

Intervention

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)

Locations

Country	Name	City	State
Finland	Prison and Probation Service of Finland	Helsinki
Finland	State Residential Schools	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

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