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

University Hospital Center (CHU)

Status: Unknown

Conditions: Apathy; Schizophrenia

Treatments: Behavioral: CM-II; Behavioral: Psychoeducation

Study type: Interventional

Funder types: Other

Identifiers

NCT04781179

RECHMPL20_0447

Details and patient eligibility

About

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.

Enrollment: 68 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 2 patient groups, including a placebo group

CM-II Technique

Experimental group

Treatment:

Behavioral: CM-II

Psychoeducation

Placebo Comparator group

Treatment:

Behavioral: Psychoeducation