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

NCT04781179 | Unknown

• 1 other identifier: RECHMPL20_0447
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Apathy

Keywords

implementation intention; mental contrasting; apathy; schizophrenia; motivation

Outcome Measures

Primary Outcomes (1)

• Change of at least one class at the Lille Apathy Rating Scale (LARS) at 3 months

  LARS (Sockeel et al. 2006, translated and validated in French by Yazbek et al. 2014) is a questionnaire semi-structured based on a multidimensional approach to apathy. It is composed of 33 grouped items in nine dimensions: activities of daily living, interests, taking initiative, interest in novelty, voluntary efforts, the intensity of emotions, worry, social life, and self-critical capability. Each item can be rated at 1 (no) or -1 (yes), a score of 0 is possible. if the answer is not classifiable. The total score on this scale ranges from -36 to +36 and allows for different classes: non-apathetic (score -36 to -22); tendency to apathy (-21 to -17); moderate apathy (-16 to -10); and severe apathy (-9 to +36).

  Change between Baseline and 3 months

Secondary Outcomes (14)

• the improvement of at least one class at the Lille Apathy Rating Scale (LARS) at 1 month

  Change between Baseline and 1 month

• the improvement of at least one class at the Lille Apathy Rating Scale (LARS) at 6 months

  Change between Baseline and 6 months

• Improvement of the score at the Calgary Depression Scale for Schizophrenia (CDSS) at 1 month

  Change between Baseline and 1 month

• Improvement of the score at the Calgary Depression Scale for Schizophrenia (CDSS) at 3 months

  Change between Baseline and 3 months

• Improvement of the score at the Calgary Depression Scale for Schizophrenia (CDSS) at 6 months

  Change between Baseline and 6 months

Study Arms (2)

CM-II Technique

EXPERIMENTAL

Behavioral: CM-II

Psychoeducation

PLACEBO COMPARATOR

Behavioral: Psychoeducation

Interventions

CM-II BEHAVIORAL

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

CM-II Technique

Psychoeducation BEHAVIORAL

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

Psychoeducation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Montpellier University Hospital

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Lethargy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Amandine Decombe

CONTACT

+33467335435; a-decombe@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: March 4, 2021
• Study Start: February 22, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: March 31, 2022

Record last verified: 2021-05

Locations

FR (1)