Effectiveness of the SKILLS Program in the Management of Psychiatric Disorders (P-SKILLS)

September 30, 2024 updated by: University Hospital, Tours

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Waiting list
Experimental: Programm SKILLS
Other: Psychotherapy
The experimental group will receive the SKILLS program, i.e. 10 group psychotherapy sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evolution in Symptom Checklist Scale (SCL 90) scores between randomization and Month 3
Time Frame: At the randomisation and Month 3
At the randomisation and Month 3

Secondary Outcome Measures

Outcome Measure
Time Frame
Evolution of Transdiagnostic Skills Scale (T2S) score
Time Frame: At randomisation, Month 3 and Month 6
At randomisation, Month 3 and Month 6
Evolution of Symptomatic Transdiagnostic Test (S2T) score
Time Frame: At randomisation, Month 3 and Month 6
At randomisation, Month 3 and Month 6
Evolution of Hosptital Anxiety Depression Scalre (HADS) score
Time Frame: At randomisation, Month 3 and Month 6
At randomisation, Month 3 and Month 6
Evolution of Satisfaction with Life Scale (SWLS) score
Time Frame: At randomisation, Month 3 and Month 6
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
At randomisation, Month 3 and Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 31, 2024

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

September 30, 2024

First Submitted That Met QC Criteria

September 30, 2024

First Posted (Actual)

October 2, 2024

Study Record Updates

Last Update Posted (Actual)

October 2, 2024

Last Update Submitted That Met QC Criteria

September 30, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DR240057

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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