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SchizophreniaCOMEIANCT04781179

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

A study testing CM-II and Psychoeducation in people with Schizophrenia and Apathy, run by University Hospital, Montpellier at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Schizophrenia, Apathy
What is being tested?
CM-II and Psychoeducation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
68 participants
Where
1 siteFrance
Study dates
22 Feb 2022to Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

France1 site, 1 recruiting
  • Montpellier University Hospital

    Montpellier, 34295

    Amandine DECOMBE, +334 67 33 54 35, a-decombe@chu-montpellier.fr

    Recruiting

Other trials in France

About this study

Official title: 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.

Being tested
CM-II, Psychoeducation
Keywords
implementation intention, mental contrasting, apathy, schizophrenia, motivation
Medical subject headings
Schizophrenia, Lethargy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CM-IIBehavioural

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

  • PsychoeducationBehavioural

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

Study groups in NCT04781179
Study groupRoleWhat they receive
CM-II TechniqueExperimentalNot described
Receives: Behavioral: CM-II
PsychoeducationPlacebo comparatorNot described
Receives: Behavioral: Psychoeducation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Change between Baseline and 3 months

Secondary outcomes (14)
  1. 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).

    Measured: Change between Baseline and 1 month

  2. 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).

    Measured: Change between Baseline and 6 months

  3. 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.

    Measured: Change between Baseline and 1 month

  4. 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.

    Measured: Change between Baseline and 3 months

  5. 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.

    Measured: Change between Baseline and 6 months

  6. 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.

    Measured: Change between Baseline and 1 month

  7. 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.

    Measured: Change between Baseline and 3 months

  8. 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.

    Measured: Change between Baseline and 6 months

  9. 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).

    Measured: Change between Baseline and 1 month

  10. 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).

    Measured: Change between Baseline and 3 months

  11. 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).

    Measured: Change between Baseline and 6 months

  12. 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").

    Measured: Change between Baseline and 1 month

  13. 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").

    Measured: Change between Baseline and 3 months

  14. 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").

    Measured: Change between Baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2021
  2. Study start22 Feb 2022
  3. Primary completionSep 2023 (estimated)
  4. Study completionSep 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04781179
Sponsor's protocol ID
RECHMPL20_0447
Acronym
COMEIA
Status last verified
May 2021
First submitted
19 Feb 2021
Last updated
31 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing CM-II and Psychoeducation in people with Schizophrenia and Apathy, run by University Hospital, Montpellier at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Amandine Decombe (+33467335435, a-decombe@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of at least one class at the Lille Apathy Rating Scale (LARS) at 3 months (time frame: Change between Baseline and 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.

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