Psychiatric DisordersP-SKILLSNCT06622993
Effectiveness of the SKILLS Program in the Management of Psychiatric Disorders
A study testing Psychotherapy in people with Psychiatric Disorders, run by University Hospital, Tours at 1 site in France.
Trial summary
Epidemiological studies show that one person in eight suffers from at least one psychiatric disorder. Mental health is therefore a major public health issue, and care for these disorders must continue to be improved. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Psychiatric Disorders
- What is being tested?
- Psychotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 14 Nov 2024to Nov 2026
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18 years of age
- Have at least one diagnosis of a psychiatric disorder
- Be able to carry out psychotherapy sessions
- Have been on stable psychiatric medication for 30 days
- Written informed consent obtained from the participant
- Be affiliated to a social security scheme or equivalent
Who cannot join
- Cognitive deficits marked by a score above the 10th percentile for one or more tests in the assessment history.
- Persons deprived of liberty by judicial or administrative decision; Persons under legal protection: guardianship or curatorship
- Presence of a severe depressive episode
- Be engaged in psychotherapeutic work elsewhere
- Presence of a state of excessive deficit, making psychotherapy impossible
- Presence of psychic decompensation (e.g. delusions) making psychotherapy impossible
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service psychiatrie
Tours, 37044
Wissam EL HAGE, MD PhD, W.ELHAGE@chu-toours.fr
About this study
Official title: Effectiveness of the SKILLS Program in the Management of Psychiatric Disorders: a Pilot Randomized Controlled Trial
Epidemiological studies show that one person in eight suffers from at least one psychiatric disorder. Mental health is therefore a major public health issue, and care for these disorders must continue to be improved.
The management of mental disorders has long followed the traditional categorical approach of developing a treatment for a given disorder. However, researchers have recently pointed out the limits of this approach in the field of mental health. They highlight the large number of co-morbidities, the existence of aspecific disorders and the intra-diagnostic heterogeneity of patients. These factors have led them to develop a transdiagnostic approach, which focuses on the mechanisms common to the various disorders in order to treat them at the same time and thus reduce the cost of treatment.
- Conditions
- Psychiatric Disorders
- Being tested
- Psychotherapy
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyOther
The experimental group will receive the SKILLS program, i.e. 10 group psychotherapy sessions.
| Study group | Role | What they receive |
|---|---|---|
| Programm SKILLS | Experimental | Not described Receives: Other: Psychotherapy |
| Waiting list | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution in Symptom Checklist Scale (SCL 90) scores between randomization and Month 3
Measured: At the randomisation and Month 3
Secondary outcomes (5)
Evolution of Transdiagnostic Skills Scale (T2S) score
Measured: At randomisation, Month 3 and Month 6
Evolution of Symptomatic Transdiagnostic Test (S2T) score
Measured: At randomisation, Month 3 and Month 6
Evolution of Hosptital Anxiety Depression Scalre (HADS) score
Measured: At randomisation, Month 3 and Month 6
Evolution of Satisfaction with Life Scale (SWLS) score
Measured: At randomisation, Month 3 and Month 6
Cumulative quantity of psychotropic treatment taken by patients (in mg)
Measured: At randomisation, Month 3 and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start14 Nov 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622993
- Sponsor's protocol ID
- DR240057
- Acronym
- P-SKILLS
- Status last verified
- Jun 2026
- First submitted
- 30 Sep 2024
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the SKILLS Program in the Management of Psychiatric Disorders: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06622993
- Acronym / sponsor ID
- P-SKILLS / DR240057
- Conditions
- Psychiatric Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 14 Nov 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 2 Oct 2024 (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.
Epidemiological studies show that one person in eight suffers from at least one psychiatric disorder. Mental health is therefore a major public health issue, and care for these disorders must continue to be improved.
The management of mental disorders has long followed the traditional categorical approach of developing a treatment for a given disorder. However, researchers have recently pointed out the limits of this approach in the field of mental health. They highlight the large number of co-morbidities, the existence of aspecific disorders and the intra-diagnostic heterogeneity of patients. These factors have led them to develop a transdiagnostic approach, which focuses on the mechanisms common to the various disorders in order to treat them at the same time and thus reduce the cost of treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Programm SKILLS | Experimental | Other: Psychotherapy |
| Waiting list | No intervention | – |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female ≥ 18 years of age
- Have at least one diagnosis of a psychiatric disorder
- Be able to carry out psychotherapy sessions
- Have been on stable psychiatric medication for 30 days
- Written informed consent obtained from the participant
Key exclusion criteria (6 listed)
- Cognitive deficits marked by a score above the 10th percentile for one or more tests in the assessment history.
- Persons deprived of liberty by judicial or administrative decision; Persons under legal protection: guardianship or curatorship
- Presence of a severe depressive episode
- Be engaged in psychotherapeutic work elsewhere
- Presence of a state of excessive deficit, making psychotherapy impossible
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 |
|---|---|---|
| PsychotherapyThe experimental group will receive the SKILLS program, i.e. 10 group psychotherapy sessions. | Other | Programm SKILLS |
Primary outcome
Evolution in Symptom Checklist Scale (SCL 90) scores between randomization and Month 3
Time frame: At the randomisation and Month 3
5 secondary outcomes
Evolution of Transdiagnostic Skills Scale (T2S) score
Time frame: At randomisation, Month 3 and Month 6
Evolution of Symptomatic Transdiagnostic Test (S2T) score
Time frame: At randomisation, Month 3 and Month 6
Evolution of Hosptital Anxiety Depression Scalre (HADS) score
Time frame: At randomisation, Month 3 and Month 6
Evolution of Satisfaction with Life Scale (SWLS) score
Time frame: At randomisation, Month 3 and Month 6
Cumulative quantity of psychotropic treatment taken by patients (in mg)
Time frame: At randomisation, Month 3 and Month 6
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 12 Jun 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy in people with Psychiatric Disorders, run by University Hospital, Tours at 1 site in France.
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 6 inclusion and 6 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 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 VANCAPPEL (+33247477111, alexis.vancappel@univ-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution in Symptom Checklist Scale (SCL 90) scores between randomization and Month 3 (time frame: At the randomisation and Month 3). 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 12 Jun 2026.