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.
