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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Schizophrenia; Apathy
• Intervention / Treatment: Behavioral: CM-II; Behavioral: Psychoeducation

• Study Type: Interventional
• Enrollment (Anticipated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amandine Decombe; Phone Number: +33467335435; Email: a-decombe@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • Montpellier University Hospital
    • Contact: Amandine DECOMBE; Phone Number: +334 67 33 54 35; Email: a-decombe@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CM-II Technique	Behavioral: CM-II; It is an intervention of 4 two-hour sessions with a psychologist, MC-II technique
Placebo Comparator: Psychoeducation	Behavioral: Psychoeducation; It is an intervention of 4 two-hour sessions with a psychologist, psychoeducation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
the improvement of at least one class at the Lille Apathy Rating Scale (LARS) at 1 month	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 1 month
the improvement of at least one class at the Lille Apathy Rating Scale (LARS) at 6 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 6 months
Improvement of the score at the Calgary Depression Scale for Schizophrenia (CDSS) at 1 month	The Calgary Depression Scale for Schizophrenia (CDSS, Addington et al., 1993; validated in French; Bernard et al., 1998) is a nine-item structured interview assessing depression in schizophrenia that measures the severity of symptoms such as depressed mood, hopelessness, guilt, insomnia and suicide.	Change between Baseline and 1 month
Improvement of the score at the Calgary Depression Scale for Schizophrenia (CDSS) at 3 months	The Calgary Depression Scale for Schizophrenia (CDSS, Addington et al., 1993; validated in French; Bernard et al., 1998) is a nine-item structured interview assessing depression in schizophrenia that measures the severity of symptoms such as depressed mood, hopelessness, guilt, insomnia and suicide.	Change between Baseline and 3 months
Improvement of the score at the Calgary Depression Scale for Schizophrenia (CDSS) at 6 months	The Calgary Depression Scale for Schizophrenia (CDSS, Addington et al., 1993; validated in French; Bernard et al., 1998) is a nine-item structured interview assessing depression in schizophrenia that measures the severity of symptoms such as depressed mood, hopelessness, guilt, insomnia and suicide.	Change between Baseline and 6 months
Improvement in the " negative symptoms " sub-score of the Positive And Negative Syndrome Scale (PANSS, Kay et al., 1987) at 1 month	The Positive And Negative Syndrome Scale is a scale hetero-evaluation of positive and negative symptomatology and general psychopathology in schizophrenia, consisting of 30 items, sides 1 to 7. The higher the score, the more severe the symptomatology. This scale provides scores on three syndromic dimensions: positive (7 items), negative (7 items) and positive (7 items), and general psychopathology (16 items) from a categorical and dimensional perspective.	Change between Baseline and 1 month
Improvement in the " negative symptoms " sub-score of the Positive And Negative Syndrome Scale (PANSS, Kay et al., 1987) at 3 months	The Positive And Negative Syndrome Scale is a scale hetero-evaluation of positive and negative symptomatology and general psychopathology in schizophrenia, consisting of 30 items, sides 1 to 7. The higher the score, the more severe the symptomatology. This scale provides scores on three syndromic dimensions: positive (7 items), negative (7 items) and positive (7 items), and general psychopathology (16 items) from a categorical and dimensional perspective.	Change between Baseline and 3 months
Improvement in the " negative symptoms " sub-score of the Positive And Negative Syndrome Scale (PANSS, Kay et al., 1987) at 6 months	The Positive And Negative Syndrome Scale is a scale hetero-evaluation of positive and negative symptomatology and general psychopathology in schizophrenia, consisting of 30 items, sides 1 to 7. The higher the score, the more severe the symptomatology. This scale provides scores on three syndromic dimensions: positive (7 items), negative (7 items) and positive (7 items), and general psychopathology (16 items) from a categorical and dimensional perspective.	Change between Baseline and 6 months
increased percentage of personal goal attainment at 1 month	Participants will be asked to list the goals they wish to achieve in 6 months or less, and the percentage of goals achieved will be assessed by the question "Were you able to achieve your goals? "to determine whether or not each personal goal was achieved. The expected response is yes vs. no for each personal goal. This methodology corresponds to the one classically used in CM-II studies (Fritzsche et al., 2016).	Change between Baseline and 1 month
increased percentage of personal goal attainment at 3 months	Participants will be asked to list the goals they wish to achieve in 6 months or less, and the percentage of goals achieved will be assessed by the question "Were you able to achieve your goals? "to determine whether or not each personal goal was achieved. The expected response is yes vs. no for each personal goal. This methodology corresponds to the one classically used in CM-II studies (Fritzsche et al., 2016).	Change between Baseline and 3 months
increased percentage of personal goal attainment at 6 months	Participants will be asked to list the goals they wish to achieve in 6 months or less, and the percentage of goals achieved will be assessed by the question "Were you able to achieve your goals? "to determine whether or not each personal goal was achieved. The expected response is yes vs. no for each personal goal. This methodology corresponds to the one classically used in CM-II studies (Fritzsche et al., 2016).	Change between Baseline and 6 months
Decreased perception of effort associated with achieving goals at 1 month	Participants will be asked to report on their perception of the effort associated with goal attainment as assessed by the question "Did achieving personal goals require you to make an effort? ". Responses will be on a 10-points Likert scale ranging from 1 ("no effort at all") to 10 ("a lot of effort").	Change between Baseline and 1 month
Decreased perception of effort associated with achieving goals at 3 months	Participants will be asked to report on their perception of the effort associated with goal attainment as assessed by the question "Did achieving personal goals require you to make an effort? ". Responses will be on a 10-points Likert scale ranging from 1 ("no effort at all") to 10 ("a lot of effort").	Change between Baseline and 3 months
Decreased perception of effort associated with achieving goals at 6 months	Participants will be asked to report on their perception of the effort associated with goal attainment as assessed by the question "Did achieving personal goals require you to make an effort? ". Responses will be on a 10-points Likert scale ranging from 1 ("no effort at all") to 10 ("a lot of effort").	Change between Baseline and 6 months

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: February 19, 2021
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 17, 2022
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: schizophrenia; motivation; implementation intention; mental contrasting; apathy
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: RECHMPL20_0447

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