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

Primary Purpose

Schizophrenia, Apathy

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CM-II
Psychoeducation
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Schizophrenia focused on measuring implementation intention, mental contrasting, apathy, schizophrenia, motivation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Montpellier University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CM-II Technique

Psychoeducation

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
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.
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.
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.
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.
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.
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.
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).
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).
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).
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").
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").
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").

Full Information

First Posted
February 19, 2021
Last Updated
March 17, 2022
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT04781179
Brief Title
Study of the Effectiveness of Mental Contrasting and Implementation Intention in the Management of Apathy in Schizophrenia
Acronym
COMEIA
Official Title
Randomized, Controlled Study of the Effectiveness of Mental Contrasting and Implementation Intention in the Management of Apathy in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 22, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Apathy
Keywords
implementation intention, mental contrasting, apathy, schizophrenia, motivation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CM-II Technique
Arm Type
Experimental
Arm Title
Psychoeducation
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
CM-II
Intervention Description
It is an intervention of 4 two-hour sessions with a psychologist, MC-II technique
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Intervention Description
It is an intervention of 4 two-hour sessions with a psychologist, psychoeducation
Primary Outcome Measure Information:
Title
Change of at least one class at the Lille Apathy Rating Scale (LARS) at 3 months
Description
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).
Time Frame
Change between Baseline and 3 months
Secondary Outcome Measure Information:
Title
the improvement of at least one class at the Lille Apathy Rating Scale (LARS) at 1 month
Description
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).
Time Frame
Change between Baseline and 1 month
Title
the improvement of at least one class at the Lille Apathy Rating Scale (LARS) at 6 months
Description
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).
Time Frame
Change between Baseline and 6 months
Title
Improvement of the score at the Calgary Depression Scale for Schizophrenia (CDSS) at 1 month
Description
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.
Time Frame
Change between Baseline and 1 month
Title
Improvement of the score at the Calgary Depression Scale for Schizophrenia (CDSS) at 3 months
Description
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.
Time Frame
Change between Baseline and 3 months
Title
Improvement of the score at the Calgary Depression Scale for Schizophrenia (CDSS) at 6 months
Description
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.
Time Frame
Change between Baseline and 6 months
Title
Improvement in the " negative symptoms " sub-score of the Positive And Negative Syndrome Scale (PANSS, Kay et al., 1987) at 1 month
Description
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.
Time Frame
Change between Baseline and 1 month
Title
Improvement in the " negative symptoms " sub-score of the Positive And Negative Syndrome Scale (PANSS, Kay et al., 1987) at 3 months
Description
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.
Time Frame
Change between Baseline and 3 months
Title
Improvement in the " negative symptoms " sub-score of the Positive And Negative Syndrome Scale (PANSS, Kay et al., 1987) at 6 months
Description
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.
Time Frame
Change between Baseline and 6 months
Title
increased percentage of personal goal attainment at 1 month
Description
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).
Time Frame
Change between Baseline and 1 month
Title
increased percentage of personal goal attainment at 3 months
Description
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).
Time Frame
Change between Baseline and 3 months
Title
increased percentage of personal goal attainment at 6 months
Description
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).
Time Frame
Change between Baseline and 6 months
Title
Decreased perception of effort associated with achieving goals at 1 month
Description
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").
Time Frame
Change between Baseline and 1 month
Title
Decreased perception of effort associated with achieving goals at 3 months
Description
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").
Time Frame
Change between Baseline and 3 months
Title
Decreased perception of effort associated with achieving goals at 6 months
Description
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").
Time Frame
Change between Baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amandine Decombe
Phone
+33467335435
Email
a-decombe@chu-montpellier.fr
Facility Information:
Facility Name
Montpellier University Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amandine DECOMBE
Phone
+334 67 33 54 35
Email
a-decombe@chu-montpellier.fr

12. IPD Sharing Statement

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

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