DEcision-making Capacity: Intervention Development & Evaluation in Schizophrenia-spectrum Disorder

Summary

Treatment decision-making capacity ('capacity') refers to a person's ability to make decisions about their treatment. It is an important issue for people diagnosed with a schizophrenia-spectrum disorder ('psychosis') because impaired capacity can mean a person does not understand what treatment options are available, or the implications of those options.

In 2018 the National Institute of Health \& Care Excellence (NICE) called for clinical trials of interventions such as talking therapies to help people regain capacity. However, running these trials can take several years. One way of reducing this delay is to run several trials at the same time, as part of one bigger trial called an 'Umbrella' trial. Although Umbrella trials have been used to accelerate the development of physical health interventions, they have yet to be used in mental health.

The main aims of this study are therefore to find out whether people with non-affective psychosis (schizophrenia-spectrum disorder) will take part in a single (rater) blind Umbrella trial of talking therapies to improve their treatment decision-making capacity (the DEC:IDES trial), and to understand their experiences of participation.

Before a larger version of the DEC:IDES trial can begin, it needs to be established that people with psychosis will want to take part in it. Specifically, the aim of this study is to establish whether they will stay in the trial until it is finished, or whether they will leave early. It will also examine why people might leave DEC:IDES early, so that it can be improved. For these reasons, a smaller version must be completed first. This will involve 3 small clinical trials, each with N=20 (Treatment N=10; Control N=10), each testing 1 of 3 different interventions. Each intervention has been designed to help participants resolve a problem which previous evidence suggests may reduce their decision-making ability. One intervention is designed to improve self-esteem, another is designed to reduce negative beliefs about psychosis ('self-stigma') and another is designed to help people with psychosis gather more information before making decisions.

The investigators will record how many people participate in and complete the trial, and they will ask people for their views on what they liked and did not like about taking part. All this information will help ensure the larger DEC:IDES trial is more acceptable to people with psychosis.

Conditions

• Schizophrenia and Related Disorders
• Mental Competency

Interventions

BEHAVIORAL

Self-esteem intervention

See relevant study arm for description

BEHAVIORAL

Self-stigma intervention

See relevant study arm for description

BEHAVIORAL

Jumping to conclusions intervention

See relevant study arm for description

BEHAVIORAL

Control procedure (assessment only)

See relevant study arms for description

Sponsors & Collaborators

• King's College London

  collaborator OTHER

• University of Edinburgh

  collaborator OTHER

• University of Manchester

  collaborator OTHER

• Pennine Care NHS Foundation Trust

  collaborator OTHER_GOV

• Lancashire Care NHS Foundation Trust

  collaborator NETWORK

• NHS Lothian

  collaborator OTHER_GOV

• Edinburgh Napier University

  lead OTHER

Principal Investigators

• Paul Hutton, ClinPsyD · Edinburgh Napier University

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-02-22

Primary Completion

2021-09-30

Completion

2022-09-30

Countries

• United Kingdom

Study Locations