Conduct DisorderCFT+VRNCT05802758
CFT-focused Mental Health Intervention With Exposure Training for Youngsters
A study testing Psychopathy.comp and training in virtual reality (VR) in people with Conduct Disorder and Psychopathic Personality Trait, run by Helsinki University Central Hospital at 2 sites in Finland.
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… Read more about this study
- Who is it for?
- Ages 15 to 20 years, men only
- Conditions the study is for
- Conduct Disorder, Psychopathic Personality Trait
- What is being tested?
- Psychopathy.comp and training in virtual reality (VR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 2 sitesFinland
- Study dates
- 1 Jan 2023to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 20 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Express conduct disorder psychopathology and psychopathic personality traits
- Are placed to a prison or a state residential school for at least 9 months
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Finland2 sites, 2 recruiting
- Recruiting
State Residential Schools
Helsinki, 00271
Marko Manninen, PhD, +358405605090, marko.manninen@thl.fi
Mirva Heikkilä, MSc
- Recruiting
Prison and Probation Service of Finland
Helsinki, 00530
Nina Lindberg, +358504270028, nina.lindberg@hus.fi
Jenni Kaunomäki, MSc
About this study
Official title: Compassion-focused Mental Health Intervention With Exposure Training in Virtual Reality for Youngsters Living in an Institution
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
- Being tested
- Psychopathy.comp and training in virtual reality (VR)
- Keywords
- psychotherapy, virtual reality, boys
- Medical subject headings
- Conduct Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychopathy.comp and training in virtual reality (VR)Behavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 months
Secondary outcomes (9)
Short Warwick-Edinburgh Wellbeing scale (SWEMWBS)
measures general psychosocial well-being
Measured: 5months
Difficulties in Emotion Regulating Scale-Short form (DERS-SF)
measures emotion regulation style
Measured: 5 months
WHO's quality of life questionnaire- Brief version (WHOQOL-BREF)
measures quality of life
Measured: 5 months
Self-Compassion Scale- Short Form (SCS-SF)
measures self-compassion
Measured: 5 months
Santa Clara Compassion Scale
masures compassion against other people
Measured: 5 months
Young Person's Clinical Outcomes in Routine Evaluation (YP-CORE)
measures how the intervention is felt by the youngster
Measured: 5 months
Situational intrinsic and extrinsic motivation scale (SIMS)
measures younster's motivation to participate the intervention
Measured: 5 months
Toronto Alexitymia Scale (TAS-20)
measures aleksitymia
Measured: 5 months
The Personal Feelings Questionnaire- brief version (PFQ-2 Brief)
measures feelings of quilt
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start1 Jan 2023
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conduct DisorderStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nina Lindberg, Helsinki University Central Hospital
- Investigators
- Nina Lindberg, PhD, Principal investigator, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802758
- Sponsor's protocol ID
- HUS/345/2023
- Acronym
- CFT+VR
- Status last verified
- Jul 2023
- First submitted
- 25 Mar 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassion-focused Mental Health Intervention With Exposure Training in Virtual Reality for Youngsters Living in an Institution
- ClinicalTrials.gov ID
- NCT05802758
- Acronym / sponsor ID
- CFT+VR / HUS/345/2023
- Conditions
- Conduct Disorder, Psychopathic Personality Trait
- Keywords
- psychotherapy, virtual reality, boys
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Youngsters who get CFT + VR | Active comparator | Behavioral: Psychopathy.comp and training in virtual reality (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 |
| Treatment as usual | No intervention | –youngsters, who get only general psychosocial rehabilitation offered by prisons and state residential schools |
Who may qualify
- Ages
- 15 to 20 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Express conduct disorder psychopathology and psychopathic personality traits
- Are placed to a prison or a state residential school for at least 9 months
Key exclusion criteria (8 listed)
- Females
- Non-Finninsh-speaking
- Remaining in the institution facility less than 9 months
- Intellectual dissability
- Presence of psychotic symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Behavioural | Youngsters who get CFT + VR |
Primary outcome
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
9 secondary outcomes
Short Warwick-Edinburgh Wellbeing scale (SWEMWBS)
Time frame: 5months
Difficulties in Emotion Regulating Scale-Short form (DERS-SF)
Time frame: 5 months
WHO's quality of life questionnaire- Brief version (WHOQOL-BREF)
Time frame: 5 months
Self-Compassion Scale- Short Form (SCS-SF)
Time frame: 5 months
Santa Clara Compassion Scale
Time frame: 5 months
Young Person's Clinical Outcomes in Routine Evaluation (YP-CORE)
Time frame: 5 months
Situational intrinsic and extrinsic motivation scale (SIMS)
Time frame: 5 months
Toronto Alexitymia Scale (TAS-20)
Time frame: 5 months
The Personal Feelings Questionnaire- brief version (PFQ-2 Brief)
Time frame: 5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nina Lindberg, PhD principal investigator
University of Helsinki
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychopathy.comp and training in virtual reality (VR) in people with Conduct Disorder and Psychopathic Personality Trait, run by Helsinki University Central Hospital at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nina Lindberg, PhD (+358504270028, nina.lindberg@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The self-reported change in Youth Pysychopathic traits Inventory- short version (YPI-S) and in the factors of it (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.