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Clinical Trials/NCT06622993
NCT06622993
Not yet recruiting
Not Applicable

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

University Hospital, Tours0 sites60 target enrollmentOctober 31, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Psychiatric Disorders
Sponsor
University Hospital, Tours
Enrollment
60
Primary Endpoint
Evolution in Symptom Checklist Scale (SCL 90) scores between randomization and Month 3
Status
Not yet recruiting
Last Updated
last year

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
October 31, 2024
End Date
October 31, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: At the randomisation and Month 3

Secondary Outcomes

  • Evolution of Transdiagnostic Skills Scale (T2S) score(At randomisation, Month 3 and Month 6)
  • Evolution of Symptomatic Transdiagnostic Test (S2T) score(At randomisation, Month 3 and Month 6)
  • Evolution of Hosptital Anxiety Depression Scalre (HADS) score(At randomisation, Month 3 and Month 6)
  • Evolution of Satisfaction with Life Scale (SWLS) score(At randomisation, Month 3 and Month 6)
  • Cumulative quantity of psychotropic treatment taken by patients (in mg)(At randomisation, Month 3 and Month 6)

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