Study of the Effectiveness of Mental Contrasting and Implementation Intention in the Management of Apathy in Schizophrenia

NCT ID: NCT04781179

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-22

Study Completion Date

2023-09-30

Brief Summary

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Schizophrenia is a mental pathology that concerns 1% of the French population, characterized by heterogeneity of symptoms. One of them, apathy is defined as a multidimensional psychopathological state manifested by a decrease in motivation. This deficit is most common in schizophrenia and impacts the functional outcome of patients. To date, no treatment has shown a significant effect on this symptom. In other pathologies with a motivational deficit, the technique of Mental Contrasting and Implementation Intention (CM-II) showed interesting effects in improving motivation, reducing the effort related to the action.

The investigators aim to propose the CM-II technique to individuals with schizophrenia to improve apathy.

The investigators expected that the CM-II technique will allow an improvement of apathy which will have beneficial effects on other psychological factors (e.g., depressive symptoms). In addition, the implementation of the CM-II will provide help to global management.

Detailed Description

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Conditions

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Schizophrenia Apathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CM-II Technique

Group Type EXPERIMENTAL

CM-II

Intervention Type BEHAVIORAL

It is an intervention of 4 two-hour sessions with a psychologist, MC-II technique

Psychoeducation

Group Type PLACEBO_COMPARATOR

Psychoeducation

Intervention Type BEHAVIORAL

It is an intervention of 4 two-hour sessions with a psychologist, psychoeducation

Interventions

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CM-II

It is an intervention of 4 two-hour sessions with a psychologist, MC-II technique

Intervention Type BEHAVIORAL

Psychoeducation

It is an intervention of 4 two-hour sessions with a psychologist, psychoeducation

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 and \< 60 years old
* Diagnosis of schizophrenia according to DSM 5 criteria.
* Score greater than or equal to -18 on the Lille Apathy Rating Scale
* Ability to understand and speak French.
* Obligation to belong to or be a beneficiary of a social security scheme.
* Signature of the consent. If the participant has a representative, signature by the representative.

Exclusion Criteria

* History of head injuries or neurological pathologies.
* Current treatment with sismotherapy or repetitive Transcranial Magnetic Stimulation (rTMS).
* Treatment targeted at and/or influencing negative symptoms (CBT, cognitive remediation), or therapeutic trial.
* Participant under safeguard of justice.
* Pregnant or breastfeeding woman.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Montpellier University Hospital

Montpellier, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Amandine Decombe

Role: CONTACT

+33467335435

Facility Contacts

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Amandine DECOMBE

Role: primary

+334 67 33 54 35

Other Identifiers

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RECHMPL20_0447

Identifier Type: -

Identifier Source: org_study_id

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