Clinical trial NCT04781179: Study of the Effectiveness of Mental Contrasting and Implementation Intention in the Management of Apathy in Schizophrenia
Official title: Randomized, Controlled Study of the Effectiveness of Mental Contrasting and Implementation Intention in the Management of Apathy in Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Apathy
Keywords: implementation intention
mental contrasting
apathy
schizophrenia
motivation
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change of at least one class at the Lille Apathy Rating Scale (LARS) at 3 months
timeFrame: Change between Baseline and 3 months
Secondary outcomes:
measure: the improvement of at least one class at the Lille Apathy Rating Scale (LARS) at 1 month
timeFrame: Change between Baseline and 1 month
measure: the improvement of at least one class at the Lille Apathy Rating Scale (LARS) at 6 months
timeFrame: Change between Baseline and 6 months
measure: Improvement of the score at the Calgary Depression Scale for Schizophrenia (CDSS) at 1 month
timeFrame: Change between Baseline and 1 month
measure: Improvement of the score at the Calgary Depression Scale for Schizophrenia (CDSS) at 3 months
timeFrame: Change between Baseline and 3 months
measure: Improvement of the score at the Calgary Depression Scale for Schizophrenia (CDSS) at 6 months
timeFrame: Change between Baseline and 6 months
measure: Improvement in the " negative symptoms " sub-score of the Positive And Negative Syndrome Scale (PANSS, Kay et al., 1987) at 1 month
timeFrame: Change between Baseline and 1 month
measure: Improvement in the " negative symptoms " sub-score of the Positive And Negative Syndrome Scale (PANSS, Kay et al., 1987) at 3 months
timeFrame: Change between Baseline and 3 months
measure: Improvement in the " negative symptoms " sub-score of the Positive And Negative Syndrome Scale (PANSS, Kay et al., 1987) at 6 months
timeFrame: Change between Baseline and 6 months
measure: increased percentage of personal goal attainment at 1 month
timeFrame: Change between Baseline and 1 month
measure: increased percentage of personal goal attainment at 3 months
timeFrame: Change between Baseline and 3 months
measure: increased percentage of personal goal attainment at 6 months
timeFrame: Change between Baseline and 6 months
measure: Decreased perception of effort associated with achieving goals at 1 month
timeFrame: Change between Baseline and 1 month
measure: Decreased perception of effort associated with achieving goals at 3 months
timeFrame: Change between Baseline and 3 months
measure: Decreased perception of effort associated with achieving goals at 6 months
timeFrame: Change between Baseline and 6 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier University Hospital
Study officials:
References: