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NCT Number: NCT05802758

CFT-focused Mental Health Intervention With Exposure Training for Youngsters

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.

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Key information

Conditions

Conduct Disorder Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders Psychopathic Personality Trait

Age range

15 year–20 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Prison and Probation Service of Finland, Helsinki, Finland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. The self-reported change in Youth Pysychopathic traits Inventory- short version (YPI-S) and in the factors of it

    Time frame: 5 months

    Measures both conduct prolems and psychopathic traits

Secondary outcomes

  1. Short Warwick-Edinburgh Wellbeing scale (SWEMWBS)

    Time frame: 5months

    measures general psychosocial well-being

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

    Time frame: 5 months

    measures emotion regulation style

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

    Time frame: 5 months

    measures quality of life

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

    Time frame: 5 months

    measures self-compassion

  5. Santa Clara Compassion Scale

    Time frame: 5 months

    masures compassion against other people

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

    Time frame: 5 months

    measures how the intervention is felt by the youngster

  7. Situational intrinsic and extrinsic motivation scale (SIMS)

    Time frame: 5 months

    measures younster's motivation to participate the intervention

  8. Toronto Alexitymia Scale (TAS-20)

    Time frame: 5 months

    measures aleksitymia

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

    Time frame: 5 months

    measures feelings of quilt

Study contacts

Contact information is provided by the study sponsor or research team.

Nina Lindberg, PhD

CONTACT

[email protected]

+358504270028

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

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

Acronym: CFT+VR

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Apr 7, 2023
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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