Effect of Metacognitive Therapy on Negative Symptoms: a Case Series

NCT03999112 | Unknown

• 1 other identifier: GN19MH107
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Schizophrenia

Keywords

psychological therapy; metacognitive reflection

Outcome Measures

Primary Outcomes (1)

• Change in Negative symptoms

  Activity levels as measured by actigraphy device

  Between baseline and week 1/week 13/week 26 of intervention

Secondary Outcomes (9)

• Clinical Assessment Interview for Negative Symptoms

  baseline and week 1, week 13 and week 26 of intervention

• Self-Evaluation of Negative Symptoms

  baseline and week 1, week 13 and week 26 of intervention

• Metacognition Assessment Scale - Adapted

  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

  measured on a weekly basis during intervention period (up to 26 weeks)

• Beck Cognitive Insight Scale

  baseline and week 1, week 13 and week 26 of intervention

Study Arms (3)

Metacognitive Reflection and Insight Therapy (MERIT) 4 week

EXPERIMENTAL

Standard MERIT + 4 week baseline period

Other: Metacognitive Reflection and Insight Therapy (MERIT)

Metacognitive Reflection and Insight Therapy (MERIT) 6 week

EXPERIMENTAL

Standard MERIT + 6 week baseline period

Other: Metacognitive Reflection and Insight Therapy (MERIT)

Metacognitive Reflection and Insight Therapy (MERIT) 8 week

EXPERIMENTAL

Standard MERIT + 8 week baseline period

Other: Metacognitive Reflection and Insight Therapy (MERIT)

Interventions

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.

Metacognitive Reflection and Insight Therapy (MERIT) 4 week; Metacognitive Reflection and Insight Therapy (MERIT) 6 week; Metacognitive Reflection and Insight Therapy (MERIT) 8 week

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator

Study Sites (1)

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Hamish McLeod, PhD CPsychol

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicola McGuire, MA (Hons) MSc

CONTACT

0141 330 5341; n.mcguire.1@research.gla.ac.uk

Hamish McLeod, PhD CPsychol

CONTACT

Hamish.McLeod@glasgow.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: June 26, 2019
• Study Start: January 22, 2020
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)