Metacognitive Training and Insight in Schizophrenia

Summary

Although insight in schizophrenia spectrum disorders (SSD) has been associated with positive outcomes, the effect size of previous treatments on insight has been relatively small to date. The metacognitive basis of insight suggests that metacognitive training (MCT) may improve insight and clinical outcomes in SSD, although this remains to be established.

This single-center, assessor-blind, parallel-group, randomised clinical trial (RCT) aims to investigate the efficacy of MCT for improving insight (primary outcome), including clinical and cognitive insight, which will be measured by the Schedule for Assessment of Insight (Expanded version) (SAI-E) and the Beck Cognitive Insight Scale (BCIS), respectively, in (at least) n=126 outpatients with SSD at three points in time: i) at baseline (Time 0); ii) after treatment (Time 1) and iii) at 1-year follow-up (Time 2). SSD patients receiving MCT and controls attending a non-intervention support group will be compared on insight level changes and several clinical and cognitive secondary outcomes after treatment and at follow-up, whilst adjusting for baseline data. Ecological momentary assessment (EMA) will be piloted to assess functioning in a subsample of participants.

This will be the first RCT testing the effect of group MCT on multiple insight dimensions (as primary outcome) in a sample of unselected patients with SSD, including several secondary clinically relevant outcomes, namely symptom severity, functioning, which will also be evaluated with EMA, hospitalizations and suicidal behaviour.

Conditions

• Schizophrenia Spectrum and Other Psychotic Disorders

Interventions

OTHER

Metacognitive training (MCT)

Metacognitive Training (MCT) was first developed in Germany in 2007 by Steffen Moritz and Todd Woodward (Moritz \& Woodward, 2007) targeting positive psychotic symptoms of patients with schizophrenia. MCT aims to change cognitive biases leading to delusional beliefs and consists of ten group sessions focused on different topics (Modules) as follows: Attributional Style (Module 1), Jumping to Conclusions (Modules 2 and 7), Changing Beliefs (Module 3), Empathy (Modules 4 and 6), Memory (Modules 5), Depression and Self-Esteem (Module 8) and two additional modules, namely Self-Esteem (Module 9) and Stigma (Module 10). Modules 8 (Self-Esteem), 9 (Self-Esteem) and 10 (Stigma) can be delivered together as one session so the intervention totals eight weekly group (3-10 participants) sessions. The MCT manual is available at: http://www.uke.de/mkt and was directly supervised by Steffen Moritz.

OTHER

Support group

Controls will attend eight weekly support groups. Seven group sessions will focus on the following topics: 1) basic activities of daily living (BADL), 2) instrumental activities of daily living (IADL), 3) physical health, 4) press-based work, 5) psychoeducation on emotions, 6) psychoeducation on illness, 7) social and family relationships. One additional session will give participants some time to openly raise general issues and concerns which were not discussed during the above sessions. Controls will be encouraged to attend these group sessions from which they are likely to benefit. While not an intervention as such, this should turn into enough incentive to reach similar attendance rates in both arms of the RCT.

Sponsors & Collaborators

• Universidad Autonoma de Madrid

  collaborator OTHER

• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

  lead OTHER

Principal Investigators

• Javier-David Lopez-Morinigo, MB BS, PhD · Hospital Universitario Fundacion Jiménez Díaz. Universidad Autónoma de Madrid. Madrid (Spain)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-10

Primary Completion

2020-12-31

Completion

2021-01-15

Countries

• Spain

Study Locations