CFT-focused Mental Health Intervention With Exposure Training for Youngsters

NCT05802758 | Recruiting

• 1 other identifier: HUS/345/2023
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 2

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.

Conditions

Conduct Disorder; Psychopathic Personality Trait

Keywords

psychotherapy, virtual reality, boys

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Short Warwick-Edinburgh Wellbeing scale (SWEMWBS)

  5months

• Difficulties in Emotion Regulating Scale-Short form (DERS-SF)

  5 months

• WHO's quality of life questionnaire- Brief version (WHOQOL-BREF)

  5 months

• Self-Compassion Scale- Short Form (SCS-SF)

  5 months

• Santa Clara Compassion Scale

  5 months

Study Arms (2)

Youngsters who get CFT + VR

ACTIVE COMPARATOR

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)

Treatment as usual

NO INTERVENTION

youngsters, who get only general psychosocial rehabilitation offered by prisons and state residential schools

Interventions

Psychopathy.comp and training in virtual reality (VR) BEHAVIORAL

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)

Youngsters who get CFT + VR

Eligibility Criteria

• Age: 15 Years - 20 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Express conduct disorder psychopathology and psychopathic personality traits
• Are placed to a prison or a state residential school for at least 9 months

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (2)

State Residential Schools

Helsinki, 00271, Finland

RECRUITING

Prison and Probation Service of Finland

Helsinki, 00530, Finland

RECRUITING

MeSH Terms

Conditions

Conduct Disorder

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Nina Lindberg, PhD

  University of Helsinki

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nina Lindberg, PhD

CONTACT

+358504270028; nina.lindberg@hus.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior doctor, professor

Study Record Dates

• First Submitted: March 25, 2023
• First Posted: April 7, 2023
• Study Start: January 1, 2023
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

FI (2)