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RecruitingNCT05802758CFT+VRUpdated Aug 1, 2023

CFT-focused Mental Health Intervention With Exposure Training for Youngsters

An interventional study of Psychopathy.comp and training in virtual reality (VR) in Conduct Disorder and Psychopathic Personality Trait, sponsored by Helsinki University Central Hospital. Recruiting at 2 sites in Finland. Open to male participants aged 15 Years to 20 Years. Per ClinicalTrials.gov, last updated 2023-08-01.

Sponsored by Helsinki University Central Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2023; still recruiting 3 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
144
Allocation
Non-randomized
Ages
15 Years to 20 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Conduct Disorder
  • Psychopathic Personality Trait

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Keywords

  • psychotherapy, virtual reality, boys
03

In context

Conduct Disorder

101 studies on the registry are indexed under Conduct Disorder; 15 are open to participants now.

This study's planned enrollment of 144 is above the median of 124 across 80 interventional studies indexed under Conduct Disorder.

Browse Conduct Disorder studies →

Lead sponsor

Helsinki University Central Hospital is the lead sponsor of 311 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 20 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
144 participants (estimated)

Study arms

  • 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)

  • No intervention
    Treatment as usual

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

Interventions

  • BehavioralPsychopathy.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)

06

What researchers measure

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

    Time frame: 5 months

Secondary outcomes

  1. Short Warwick-Edinburgh Wellbeing scale (SWEMWBS)

    measures general psychosocial well-being

    Time frame: 5months

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

    measures emotion regulation style

    Time frame: 5 months

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

    measures quality of life

    Time frame: 5 months

  4. Self-Compassion Scale- Short Form (SCS-SF)

    measures self-compassion

    Time frame: 5 months

  5. Santa Clara Compassion Scale

    masures compassion against other people

    Time frame: 5 months

  6. Young Person's Clinical Outcomes in Routine Evaluation (YP-CORE)

    measures how the intervention is felt by the youngster

    Time frame: 5 months

  7. Situational intrinsic and extrinsic motivation scale (SIMS)

    measures younster's motivation to participate the intervention

    Time frame: 5 months

  8. Toronto Alexitymia Scale (TAS-20)

    measures aleksitymia

    Time frame: 5 months

  9. The Personal Feelings Questionnaire- brief version (PFQ-2 Brief)

    measures feelings of quilt

    Time frame: 5 months

07

Study locations

2 of 2 sites recruiting
  • State Residential Schools
    Helsinki, 00271, Finland
    Recruiting
    • Marko Manninen, PhD · Contactmarko.manninen@thl.fi · +358405605090
    • Mirva Heikkilä, MSc · Sub investigator
  • Prison and Probation Service of Finland
    Helsinki, 00530, Finland
    Recruiting
    • Nina Lindberg · Contactnina.lindberg@hus.fi · +358504270028
    • Jenni Kaunomäki, MSc · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05802758
Responsible party
Nina Lindberg (senior doctor, professor, Helsinki University Central Hospital) — Principal investigator
First posted
Apr 7, 2023
Start date
Jan 1, 2023
Primary completion
Sep 30, 2028 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Aug 1, 2023

Study contacts

Nina Lindberg, PhD
Contact
nina.lindberg@hus.fi
+358504270028
Nina Lindberg, PhD
principal investigator · University of Helsinki

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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