SchizophreniaNCT03999112
Effect of Metacognitive Therapy on Negative Symptoms: a Case Series
A study testing Metacognitive Reflection and Insight Therapy (MERIT) in people with Schizophrenia, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
Negative symptoms (e.g. diminished pleasure and motivation) are common in people with a diagnosis of schizophrenia. Little is known about the psychological mechanisms involved in negative symptom development and maintenance and there is limited evidence for current treatment options. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Metacognitive Reflection and Insight Therapy (MERIT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Jan 2020to Apr 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving inpatient rehabilitation services in NHS GG\&C
- Schizophrenia spectrum diagnosis, defined by diagnostic codes F20-29 from the International Classification of Diseases - 10th Edition (ICD-10; World Health Organization, 1992)
- Sufficient capacity to provide informed consent, as determined by treating clinician
- Score 4 or above from a possible total score of 8 in any subdomain of negative symptoms (alogia, avolition,anhedonia, social withdrawal or diminished emotional range) on the Self-evaluation of Negative Symptoms measure (SNS)
- Moderate to severe scores on either the motivation and pleasure scale or the expression scale of the Clinical Assessment Interview for Negative Symptoms (CAINS; resulting in a required score of 18 or above for items 1-9 and a score of 8 or above for items 10-13)
Who cannot join
- None, assuming all Inclusion Criteria are met
Trial locations and contacts
1 site in 1 country.
Hamish McLeod, PhD CPsychol contact
United Kingdom1 site, 1 recruiting
- Recruiting
NHS Greater Glasgow and Clyde
Glasgow
About this study
Official title: A Case Series Examination of Metacognitive Reflection and Insight Therapy (MERIT) on Individual Negative Symptoms of Schizophrenia
Negative symptoms (e.g. diminished pleasure and motivation) are common in people with a diagnosis of schizophrenia. Little is known about the psychological mechanisms involved in negative symptom development and maintenance and there is limited evidence for current treatment options. Some research suggests that difficulties with metacognition; the capacity to develop and use complex ideas about oneself and others, may predict experiences of negative symptoms. This study will investigate whether Metacognitive Reflection and Insight Therapy (MERIT) improves metacognition in people experiencing negative symptoms, and if metacognitive changes lead to observable differences in behavioural manifestations of negative symptoms (e.g. low activity levels).
Data will be collected via standardised assessments of metacognition and negative symptoms. Activity levels will be measured with actigraphy, which has been shown to capture differential activity patterns for individuals who experience negative symptoms compared to control groups. An assessment will also be made of whether improvements in specific aspects of metacognition (e.g. self-reflectivity) relate to changes in individual negative symptoms, such as motivation levels, and other markers of personal change, including personal and social performance, insight, and beliefs about recovery.
Additionally, factors that may have impacted on the study results, such as therapist adherence to the treatment, will be reported. Eligible patients with capacity to consent will be recruited from the inpatient rehabilitation psychology services in National Health Service (NHS) Greater Glasgow and Clyde. They will be aged 18 or over, have a schizophrenia spectrum disorder diagnosis, and experience current negative symptoms. The target sample size is up to 8 patients. Participants will be measured at baseline and will receive up to 26 sessions of the MERIT treatment approach. Any therapeutic change will be observed via changes from assessments at baseline to the assessments in the initial, middle and last therapy sessions, and also metacognitive assessments at two other randomly selected time-points during therapy.
Read the detailed description
Hypotheses around metacognitive changes:
It is hypothesised that metacognition scores on the Metacognition Assessment Scale - Abbreviated (MAS-A) will increase with the implementation of Metacognitive Reflection and Insight Therapy (MERIT) over the course of treatment. It is also estimated that this will be related to changes in therapist-rated metacognition, and measures of participant insight (using the Beck Cognitive Insight Scale; BCIS). It is also anticipated that changes in participants' metacognition will also be related to whether therapist metacognition appears to match the level of participant metacognition demonstrated within session.
Hypotheses around impact on negative symptoms and secondary outcomes:
It is estimated that fewer manifestations of negative symptoms (e.g. low-activity levels) will be observed over the course of therapy compared to the baseline period, and that this will also be related to changes in the Clinical Assessment Interview of Negative Symptoms (CAINS), the Self-experience of Negative Symptoms scale (SNS), the Personal and Social Performance Scale (PSP), the Personal Questionnaire: Rapid Scaling Technique (PQRST) and the Questionnaire about the Process of Recovery (QPR).
Design rationale:
The SCED methodology and the use of measures of metacognition and negative symptoms over time was chosen because this allows examination of they key study hypotheses without the need for a standard control group design. This, coupled with the use of standardised measures, ensures that researchers can be confident that any therapeutic changes demonstrated in the study are more likely to be attributed to MERIT than by chance. This also serves as a cost-effective option for investigating the relationship between metacognition and negative symptoms and will identify ways MERIT can be tailored to these specific symptoms, giving an evidence base to build upon and understand how these factors, and particularly their subdomains, are related.
Timeline:
Training of therapists in MERIT has taken place. Recruitment will begin once ethical approval is in place. Participants will be randomly allocated to a baseline period of 4, 6, or 8 weeks during which they will complete a baseline assessment and receive instruction on how to use the actigraph device, and data on all measures other than the MAS-A and the PQRST (which are in-session data), will be recorded during the baseline period. The intervention will last up to 26 sessions, with interpretation, analyses and write up of the research completed thereafter. To avoid the introduction of bias to subsequent assessments or the intervention itself, there will be no interim analyses of the results, however researchers and therapists will remain vigilant to any detrimental affects to participants and any desire participants may have to stop participating in the research.
Additionally, the researcher will have no discussions with the therapists about how therapy is progressing for any participants, unless there is significant risk to the participant or others. Both MERIT sessions and the assessments by the researcher will take place in rehab wards in NHS Greater Glasgow and Clyde (GG\&C).
Procedure:
Participants will be subject to researcher assessment (in scoring of the the CAINS and the MAS-A) and also therapist rated metacognition, and the PSP which is based on key worker observations. Participants medical access will also be accessed proportionately to gain demographic information and information about diagnosis. Participants will be made aware of this at the point of providing informed consent, and any perceived risk to the participant or others that is identified during these observations will be discussed with the participant where appropriate. Additionally, participants will provide self-report information via their report of time use and answers on the BCIS, SNS, the PQRST, and the QPR and to demographic questions. Also participants will be asked to wear actigraph devices which will allow participants' activity levels to be tracked. Participants will again be informed of the purposes of collecting these data and any concerns participants have will be discussed throughout the study as required. Whether participants continue to provide consent will also be checked throughout the study and participants will be able to stop providing data on a particular measure alone, or discontinue the study entirely, if they no longer consent to this.
The target sample size will be up to 8 participants, this has previously been identified as sufficient for SCED methodology, and given that participants will be identified through rehab wards in NHS GG\&C, it is anticipated that this target sample size can be met.
Feasibility:
It is anticipated that inclusion criteria for this research will ensure individuals eligible will be those who experience persistent negative symptoms and who are already be expected to receive some form of psychological therapy as part of their NHS care and treatment. Therefore, the testing of MERIT, which is aimed at the treatment of negative symptoms, while novel, should not incur any additional cost or NHS resources.
- Conditions
- Schizophrenia
- Being tested
- Metacognitive Reflection and Insight Therapy (MERIT)
- Keywords
- psychological therapy, metacognitive reflection
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacognitive Reflection and Insight Therapy (MERIT)Other
A psychological therapy aiming to increase the ability of individuals to synthesise perceptions about themselves and others; to then form complex narratives which recognise the occurrence of these within particular social contexts; and to use these to form responses to psychological problems.
| Study group | Role | What they receive |
|---|---|---|
| Metacognitive Reflection and Insight Therapy (MERIT) 4 week | Experimental | Standard MERIT + 4 week baseline period Receives: Other: Metacognitive Reflection and Insight Therapy (MERIT) |
| Metacognitive Reflection and Insight Therapy (MERIT) 6 week | Experimental | Standard MERIT + 6 week baseline period Receives: Other: Metacognitive Reflection and Insight Therapy (MERIT) |
| Metacognitive Reflection and Insight Therapy (MERIT) 8 week | Experimental | Standard MERIT + 8 week baseline period Receives: Other: Metacognitive Reflection and Insight Therapy (MERIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Negative symptoms
Activity levels as measured by actigraphy device
Measured: Between baseline and week 1/week 13/week 26 of intervention
Secondary outcomes (9)
Clinical Assessment Interview for Negative Symptoms
Clinical interview measuring 13 items on a scale of 0 - 4 where 0 indicates no impairment, 1 indicates mild deficit, 2 indicates moderate deficit, 3 indicates moderately severe deficit, and 4 indicates severe deficits. Items are summed and form a total score and 2 subscale scores on the motivation and pleasure and also the expression subscale. A greater score indicates greater negative symptom impairments.
Measured: baseline and week 1, week 13 and week 26 of intervention
Self-Evaluation of Negative Symptoms
20 items measuring negative symptoms rated by participant on a likert scale where 0 represents strongly disagree, 1 represents somewhat agree, and 2 represents strongly agree. Total score is the sum of all items and a greater score indicates greater levels of negative symptoms.
Measured: baseline and week 1, week 13 and week 26 of intervention
Metacognition Assessment Scale - Adapted
4 components of metacognition rated from rater assessment of participant interviews - self-reflectivity, understanding the mind of the other, decentration, mastery. Ratings on a scale of 0-1 for each level of metacognition demonstrated in each subscale with half a point awarded when partially demonstrated. Ranges for subscales are: self-reflectivity, 0-9; understanding the mind of the other, 0-7; decentration, 0-3; and mastery, 0-9. Total score is the sum of all subscales and ranges from 0-28. For all scores a lower score indicates lower levels of metacognition.
Measured: baseline and week 1, week 13 and week 26 of intervention, plus two randomly selected timepoints between weeks 1-13 of intervention and weeks 14-26 of intervention.
Metacognition Assessment Scale - Adapted, therapist rated
4 components of metacognition rated by therapist based on therapy session - self-reflectivity, understanding the mind of the other, decentration, mastery. Ratings on a scale of 0-1 for each level of metacognition demonstrated in each subscale with half a point awarded when partially demonstrated. Ranges for subscales are: self-reflectivity, 0-9; understanding the mind of the other, 0-7; decentration, 0-3; and mastery, 0-9. Total score is the sum of all subscales and ranges from 0-28. For all scores a lower score indicates lower levels of metacognition.
Measured: measured on a weekly basis during intervention period (up to 26 weeks)
Beck Cognitive Insight Scale
15 items measuring cognitive insight separated into two subscales: self-reflectiveness and self-certainty. Participants will rate items between 0-3, resulting in a total score of between 0 and 27 for the self-reflectiveness subscale and 0 - 18 for the self-certainty subscale. For both subscales, higher scores are reflective of higher self-reflectiveness and higher self-certainty. The two scales are compared by calculating a composite index, which is the sum of self-reflectivity minus the sum of self-certainty subscales.
Measured: baseline and week 1, week 13 and week 26 of intervention
Personal and Social Performance scale
Measure giving an impression of social interactions, personal care, and aggression or disturbing behaviours exhibited. 4 domains of functioning (socially useful activities, including work or academic study; personal and social relationships; self-care; and disturbing and aggressive behaviours) are rated by a key worker from the following ordinal options: absent, mild, manifest, marked, severe and very severe. The number of difficulties across four areas and their severity are used to select a score between 1-100 at a 10 point interval and clinical judgement is used to adjust the score within the 10 point interval by accounting for other areas of social functioning. Participants thus receive a score between 1 and 100.
Measured: baseline and week 1, week 13 and week 26 of intervention
Personal Questionnaire Rapid Scaling Technique
1-5 meaningful personal statements agreed between participant and therapist; presented and asked if intensity greater or less than previous discussion. All items scored between 1-5 as a likert scale for the following 5 ordinal options: not at all (1), occasionally (2), sometimes (3), often (4), most of the time (5). A greater score indicates an item is a greater problem for participant than a lower score. Items are not aggregated.
Measured: measured on a weekly basis during intervention period (up to 26 weeks)
Time Use Survey
A measure of time use based on participant report of activities across a given week. Descriptive characteristics of activities are recorded including whether this was with other individuals, whether the activity was someone else's idea, whether these activities were started recently or the participant intends to take up new activities, and how satisfied the participant is with their overall levels of activity on a likert scale from 1-5 where 1 indicates very satisfied, 2 somewhat satisfied, 3 neither satisfied or dissatisfied, 4 somewhat dissatisfied, and 5 very dissatisfied. Activities are scored against criteria ranging from 0-4 where a lower score indicates a lower activity level and level of independence. Sum scores are reported for number of activities, activity level according to criteria, number of activities with others, new activities and satisfaction with activities.
Measured: baseline and week 1, week 13 and week 26 of intervention
Questionnaire about the Process of Recovery
15 items about the process of recovery rated by participants where items are selected from the following ordinal responses: disagree strongly, disagree, neither agree nor disagree, agree and agree strongly. Each of these responses represent a score of 0-4 respectively, and the total score is a summation of scores for all items. A higher score represents more experiences of recovery.
Measured: baseline and week 1, week 13 and week 26 of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start22 Jan 2020
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Single case experimental design (SCED). Participants will be randomised to a baseline period, and after either 4, 6 or 8 weeks they will then be allocated to the same intervention.
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Hamish McLeod, PhD CPsychol, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999112
- Sponsor's protocol ID
- GN19MH107
- Status last verified
- Jan 2020
- First submitted
- 20 May 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case Series Examination of Metacognitive Reflection and Insight Therapy (MERIT) on Individual Negative Symptoms of Schizophrenia
- ClinicalTrials.gov ID
- NCT03999112
- Acronym / sponsor ID
- GN19MH107
- Conditions
- Schizophrenia
- Keywords
- psychological therapy, metacognitive reflection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 26 Jun 2019 (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.
Negative symptoms (e.g. diminished pleasure and motivation) are common in people with a diagnosis of schizophrenia. Little is known about the psychological mechanisms involved in negative symptom development and maintenance and there is limited evidence for current treatment options. Some research suggests that difficulties with metacognition; the capacity to develop and use complex ideas about oneself and others, may predict experiences of negative symptoms. This study will investigate whether Metacognitive Reflection and Insight Therapy (MERIT) improves metacognition in people experiencing negative symptoms, and if metacognitive changes lead to observable differences in behavioural manifestations of negative symptoms (e.g. low activity levels).
Data will be collected via standardised assessments of metacognition and negative symptoms. Activity levels will be measured with actigraphy, which has been shown to capture differential activity patterns for individuals who experience negative symptoms compared to control groups. An assessment will also be made of whether improvements in specific aspects of metacognition (e.g. self-reflectivity) relate to changes in individual negative symptoms, such as motivation levels, and other markers of personal change, including personal and social performance, insight, and beliefs about recovery.
Additionally, factors that may have impacted on the study results, such as therapist adherence to the treatment, will be reported. Eligible patients with capacity to consent will be recruited from the inpatient rehabilitation psychology services in National Health Service (NHS) Greater Glasgow and Clyde. They will be aged 18 or over, have a schizophrenia spectrum disorder diagnosis, and experience current negative symptoms. The target sample size is up to 8 patients. Participants will be measured at baseline and will receive up to 26 sessions of the MERIT treatment approach. Any therapeutic change will be observed via changes from assessments at baseline to the assessments in the initial, middle and last therapy sessions, and also metacognitive assessments at two other randomly selected time-points during therapy.
Detailed description
Hypotheses around metacognitive changes:
It is hypothesised that metacognition scores on the Metacognition Assessment Scale - Abbreviated (MAS-A) will increase with the implementation of Metacognitive Reflection and Insight Therapy (MERIT) over the course of treatment. It is also estimated that this will be related to changes in therapist-rated metacognition, and measures of participant insight (using the Beck Cognitive Insight Scale; BCIS). It is also anticipated that changes in participants' metacognition will also be related to whether therapist metacognition appears to match the level of participant metacognition demonstrated within session.
Hypotheses around impact on negative symptoms and secondary outcomes:
It is estimated that fewer manifestations of negative symptoms (e.g. low-activity levels) will be observed over the course of therapy compared to the baseline period, and that this will also be related to changes in the Clinical Assessment Interview of Negative Symptoms (CAINS), the Self-experience of Negative Symptoms scale (SNS), the Personal and Social Performance Scale (PSP), the Personal Questionnaire: Rapid Scaling Technique (PQRST) and the Questionnaire about the Process of Recovery (QPR).
Design rationale:
The SCED methodology and the use of measures of metacognition and negative symptoms over time was chosen because this allows examination of they key study hypotheses without the need for a standard control group design. This, coupled with the use of standardised measures, ensures that researchers can be confident that any therapeutic changes demonstrated in the study are more likely to be attributed to MERIT than by chance. This also serves as a cost-effective option for investigating the relationship between metacognition and negative symptoms and will identify ways MERIT can be tailored to these specific symptoms, giving an evidence base to build upon and understand how these factors, and particularly their subdomains, are related.
Timeline:
Training of therapists in MERIT has taken place. Recruitment will begin once ethical approval is in place. Participants will be randomly allocated to a baseline period of 4, 6, or 8 weeks during which they will complete a baseline assessment and receive instruction on how to use the actigraph device, and data on all measures other than the MAS-A and the PQRST (which are in-session data), will be recorded during the baseline period. The intervention will last up to 26 sessions, with interpretation, analyses and write up of the research completed thereafter. To avoid the introduction of bias to subsequent assessments or the intervention itself, there will be no interim analyses of the results, however researchers and therapists will remain vigilant to any detrimental affects to participants and any desire participants may have to stop participating in the research.
Additionally, the researcher will have no discussions with the therapists about how therapy is progressing for any participants, unless there is significant risk to the participant or others. Both MERIT sessions and the assessments by the researcher will take place in rehab wards in NHS Greater Glasgow and Clyde (GG\&C).
Procedure:
Participants will be subject to researcher assessment (in scoring of the the CAINS and the MAS-A) and also therapist rated metacognition, and the PSP which is based on key worker observations. Participants medical access will also be accessed proportionately to gain demographic information and information about diagnosis. Participants will be made aware of this at the point of providing informed consent, and any perceived risk to the participant or others that is identified during these observations will be discussed with the participant where appropriate. Additionally, participants will provide self-report information via their report of time use and answers on the BCIS, SNS, the PQRST, and the QPR and to demographic questions. Also participants will be asked to wear actigraph devices which will allow participants' activity levels to be tracked. Participants will again be informed of the purposes of collecting these data and any concerns participants have will be discussed throughout the study as required. Whether participants continue to provide consent will also be checked throughout the study and participants will be able to stop providing data on a particular measure alone, or discontinue the study entirely, if they no longer consent to this.
The target sample size will be up to 8 participants, this has previously been identified as sufficient for SCED methodology, and given that participants will be identified through rehab wards in NHS GG\&C, it is anticipated that this target sample size can be met.
Feasibility:
It is anticipated that inclusion criteria for this research will ensure individuals eligible will be those who experience persistent negative symptoms and who are already be expected to receive some form of psychological therapy as part of their NHS care and treatment. Therefore, the testing of MERIT, which is aimed at the treatment of negative symptoms, while novel, should not incur any additional cost or NHS resources.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Single case experimental design (SCED). Participants will be randomised to a baseline period, and after either 4, 6 or 8 weeks they will then be allocated to the same intervention.
| Arm | Type | Receives |
|---|---|---|
| Metacognitive Reflection and Insight Therapy (MERIT) 4 week | Experimental | Other: Metacognitive Reflection and Insight Therapy (MERIT)Standard MERIT + 4 week baseline period |
| Metacognitive Reflection and Insight Therapy (MERIT) 6 week | Experimental | Other: Metacognitive Reflection and Insight Therapy (MERIT)Standard MERIT + 6 week baseline period |
| Metacognitive Reflection and Insight Therapy (MERIT) 8 week | Experimental | Other: Metacognitive Reflection and Insight Therapy (MERIT)Standard MERIT + 8 week baseline period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Receiving inpatient rehabilitation services in NHS GG\&C
- Schizophrenia spectrum diagnosis, defined by diagnostic codes F20-29 from the International Classification of Diseases - 10th Edition (ICD-10; World Health Organization, 1992)
- Sufficient capacity to provide informed consent, as determined by treating clinician
- Score 4 or above from a possible total score of 8 in any subdomain of negative symptoms (alogia, avolition,anhedonia, social withdrawal or diminished emotional range) on the Self-evaluation of Negative Symptoms measure (SNS)
- Moderate to severe scores on either the motivation and pleasure scale or the expression scale of the Clinical Assessment Interview for Negative Symptoms (CAINS; resulting in a required score of 18 or above for items 1-9 and a score of 8 or above for items 10-13)
Key exclusion criteria (1 listed)
- None, assuming all Inclusion Criteria are met
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 |
|---|---|---|
| Metacognitive Reflection and Insight Therapy (MERIT)A psychological therapy aiming to increase the ability of individuals to synthesise perceptions about themselves and others; to then form complex narratives which recognise the occurrence of these within particular social contexts; and to use these to form responses to psychological problems. | Other | Metacognitive Reflection and Insight Therapy (MERIT) 4 week, Metacognitive Reflection and Insight Therapy (MERIT) 6 week, Metacognitive Reflection and Insight Therapy (MERIT) 8 week |
Primary outcome
Change in Negative symptoms
Time frame: Between baseline and week 1/week 13/week 26 of intervention
Activity levels as measured by actigraphy device
9 secondary outcomes
Clinical Assessment Interview for Negative Symptoms
Time frame: baseline and week 1, week 13 and week 26 of intervention
Self-Evaluation of Negative Symptoms
Time frame: baseline and week 1, week 13 and week 26 of intervention
Metacognition Assessment Scale - Adapted
Time frame: baseline and week 1, week 13 and week 26 of intervention, plus two randomly selected timepoints between weeks 1-13 of intervention and weeks 14-26 of intervention.
Metacognition Assessment Scale - Adapted, therapist rated
Time frame: measured on a weekly basis during intervention period (up to 26 weeks)
Beck Cognitive Insight Scale
Time frame: baseline and week 1, week 13 and week 26 of intervention
Personal and Social Performance scale
Time frame: baseline and week 1, week 13 and week 26 of intervention
Personal Questionnaire Rapid Scaling Technique
Time frame: measured on a weekly basis during intervention period (up to 26 weeks)
Time Use Survey
Time frame: baseline and week 1, week 13 and week 26 of intervention
Questionnaire about the Process of Recovery
Time frame: baseline and week 1, week 13 and week 26 of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Hamish McLeod, PhD CPsychol contact
Hamish McLeod, PhD CPsychol principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metacognitive Reflection and Insight Therapy (MERIT) in people with Schizophrenia, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
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 5 inclusion and 1 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 27 Jan 2020. 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 United Kingdom. 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. 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 Nicola McGuire, MA (Hons) MSc (0141 330 5341, n.mcguire.1@research.gla.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Negative symptoms (time frame: Between baseline and week 1/week 13/week 26 of intervention). 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 27 Jan 2020.