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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
- Recruiting
Montpellier University Hospital
Montpellier, 34295
Amandine DECOMBE, +334 67 33 54 35, a-decombe@chu-montpellier.fr
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.
- Conditions
- Schizophrenia, Apathy
- 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 group | Role | What they receive |
|---|---|---|
| CM-II Technique | Experimental | Not described Receives: Behavioral: CM-II |
| Psychoeducation | Placebo comparator | Not described Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted4 Mar 2021
- Study start22 Feb 2022
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Study of the Effectiveness of Mental Contrasting and Implementation Intention in the Management of Apathy in Schizophrenia
- ClinicalTrials.gov ID
- NCT04781179
- Acronym / sponsor ID
- COMEIA / RECHMPL20_0447
- Conditions
- Schizophrenia, Apathy
- Keywords
- implementation intention, mental contrasting, apathy, schizophrenia, motivation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CM-II Technique | Experimental | Behavioral: CM-II |
| Psychoeducation | Placebo comparator | Behavioral: Psychoeducation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CM-IIIt is an intervention of 4 two-hour sessions with a psychologist, MC-II technique | Behavioural | CM-II Technique |
| PsychoeducationIt is an intervention of 4 two-hour sessions with a psychologist, psychoeducation | Behavioural | Psychoeducation |
Primary outcome
Change of at least one class at the Lille Apathy Rating Scale (LARS) at 3 months
Time frame: Change between Baseline and 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).
14 secondary outcomes
the improvement of at least one class at the Lille Apathy Rating Scale (LARS) at 1 month
Time frame: Change between Baseline and 1 month
the improvement of at least one class at the Lille Apathy Rating Scale (LARS) at 6 months
Time frame: Change between Baseline and 6 months
Improvement of the score at the Calgary Depression Scale for Schizophrenia (CDSS) at 1 month
Time frame: Change between Baseline and 1 month
Improvement of the score at the Calgary Depression Scale for Schizophrenia (CDSS) at 3 months
Time frame: Change between Baseline and 3 months
Improvement of the score at the Calgary Depression Scale for Schizophrenia (CDSS) at 6 months
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change between Baseline and 6 months
increased percentage of personal goal attainment at 1 month
Time frame: Change between Baseline and 1 month
increased percentage of personal goal attainment at 3 months
Time frame: Change between Baseline and 3 months
increased percentage of personal goal attainment at 6 months
Time frame: Change between Baseline and 6 months
Decreased perception of effort associated with achieving goals at 1 month
Time frame: Change between Baseline and 1 month
Decreased perception of effort associated with achieving goals at 3 months
Time frame: Change between Baseline and 3 months
Decreased perception of effort associated with achieving goals at 6 months
Time frame: Change between Baseline and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.