Effectiveness of the SKILLS Program in the Management of Psychiatric Disorders

NCT06622993 | Not Yet Recruiting

• 1 other identifier: DR240057
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Psychiatric Disorders

Outcome Measures

Primary Outcomes (1)

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

  At the randomisation and Month 3

Secondary Outcomes (5)

• 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

Study Arms (2)

Programm SKILLS

EXPERIMENTAL

Other: Psychotherapy

Waiting list

NO INTERVENTION

Interventions

Psychotherapy OTHER

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

Programm SKILLS

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead

MeSH Terms

Conditions

Mental Disorders

Interventions

Psychotherapy

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Central Study Contacts

VANCAPPEL

CONTACT

+33247477111; alexis.vancappel@univ-tours.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 2, 2024
• Study Start: October 31, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: October 2, 2024

Record last verified: 2024-09