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NCT Number: NCT06622993

Effectiveness of the SKILLS Program in the Management of Psychiatric Disorders

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service psychiatrie

Tours, 37044, France

Location status: Recruiting

Location contact

Wissam EL HAGE, MD PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Psychotherapy

Other

The experimental group will receive the SKILLS program, i.e. 10 group psychotherapy sessions.

Primary outcomes

  1. Evolution in Symptom Checklist Scale (SCL 90) scores between randomization and Month 3

    Time frame: At the randomisation and Month 3

Secondary outcomes

  1. Evolution of Transdiagnostic Skills Scale (T2S) score

    Time frame: At randomisation, Month 3 and Month 6

  2. Evolution of Symptomatic Transdiagnostic Test (S2T) score

    Time frame: At randomisation, Month 3 and Month 6

  3. Evolution of Hosptital Anxiety Depression Scalre (HADS) score

    Time frame: At randomisation, Month 3 and Month 6

  4. Evolution of Satisfaction with Life Scale (SWLS) score

    Time frame: At randomisation, Month 3 and Month 6

  5. Cumulative quantity of psychotropic treatment taken by patients (in mg)

    Time frame: At randomisation, Month 3 and Month 6

Study contacts

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

VANCAPPEL

CONTACT

[email protected]

+33247477111

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

Effectiveness of the SKILLS Program in the Management of Psychiatric Disorders: a Pilot Randomized Controlled Trial

Acronym: P-SKILLS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 2, 2024
Registry last updated
Jun 12, 2026

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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