Skip to main content

Research Repository

Advanced Search

Accelerating the development of a psychological intervention to restore treatment decision-making capacity in patients with schizophrenia-spectrum disorder: a study protocol for a multi-site, assessor-blinded, pilot Umbrella trial (the DEC:IDES trial)

Hutton, Paul; Kelly, James; Taylor, Christopher D.J.; Williams, Brian; Emsley, Richard; Alexander, Candy Ho; Vikram, Anvita; Saddington, David; McCann, Andrea; Burke, Joseph; Eliasson, Emma; Harper, Sean; Karatzias, Thanos; Taylor, Peter J.; Watson, Andrew; Dougall, Nadine; Stavert, Jill; O’Rourke, Suzanne; Glasgow, Angela; Murphy, Regina; Palmer, Karen; Zaidi, Nosheen; Bidwell, Polly; Pritchard, Jemma; Carr, Lucy; Woodrow, Amanda

Authors

James Kelly

Christopher D.J. Taylor

Brian Williams

Richard Emsley

Candy Ho Alexander

Anvita Vikram

David Saddington

Andrea McCann

Joseph Burke

Emma Eliasson

Sean Harper

Peter J. Taylor

Andrew Watson

Suzanne O’Rourke

Angela Glasgow

Regina Murphy

Karen Palmer

Nosheen Zaidi

Polly Bidwell

Jemma Pritchard

Lucy Carr



Abstract

Background:
A high proportion of patients diagnosed with schizophrenia-spectrum disorders will at some point in their lives be assessed as not having the capacity to make their own decisions about pharmacological treatment or inpatient care (‘capacity’). Few will be helped to regain it before these interventions proceed. This is partly because effective and safe methods to do so are lacking. Our aim is to accelerate their development by testing, for the first time in mental healthcare, the feasibility, acceptability and safety of running an ‘Umbrella’ trial. This involves running, concurrently and under one multi-site infrastructure, multiple assessor-blind randomised controlled trials, each of which are designed to examine the effect on capacity of improving a single psychological mechanism (‘mechanism’). Our primary objectives are to demonstrate feasibility of (i) recruitment and (ii) data retention on the MacArthur Competence Assessment Tool-Treatment (MacCAT-T; planned primary outcome for a future trial) at end-of-treatment. We selected three mechanisms to test; ‘self-stigma’, low self-esteem and the ‘jumping to conclusions’ bias. Each is highly prevalent in psychosis, responsive to psychological intervention, and hypothesised to contribute to impaired capacity.

Methods:
Sixty participants with schizophrenia-spectrum diagnoses, impaired capacity, and one or more mechanism(s) will be recruited from outpatient and inpatient mental health services in three UK sites (Lothian, Scotland; Lancashire and Pennine, North West England). Those lacking capacity to consent to research could take part if key criteria were met, including either proxy consent (Scotland) or favourable Consultee advice (England). They will be allocated to one of three randomised controlled trials, depending on which mechanism(s) they have. They will then be randomised to receive, over an 8-week period and in addition to treatment as usual (TAU), 6 sessions of either a psychological intervention which targets the mechanism, or 6 sessions of assessment of the causes of their incapacity (control condition). Participants are assessed at 0 (baseline), 8 (end-of-treatment) and 24 (follow-up) weeks post-randomisation using measures of capacity (MacCAT-T), mechanism, adverse events, psychotic symptoms, subjective recovery, quality of life, service use, anxiety, core schemata, and depression. Two nested qualitative studies will be conducted; one to understand participant and clinician experiences, and one to investigate the validity of MacCAT-T appreciation ratings.

Discussion:
This will be the first Umbrella trial in mental healthcare. It will produce the first 3 single-blind randomised controlled trials of psychological interventions to support treatment decision-making in schizophrenia-spectrum disorder. Demonstrating feasibility will have significant implications not only for those seeking to support capacity in psychosis, but also those who wish to accelerate the development of psychological interventions for other conditions.

Trial registration:
ClinicalTrials.gov NCT04309435. Pre-registered on 16th March 2020.
https://clinicaltrials.gov/ct2/show/NCT04309435

Journal Article Type Article
Acceptance Date May 26, 2023
Online Publication Date Jul 8, 2023
Publication Date 2023
Deposit Date Jun 9, 2023
Publicly Available Date Jul 8, 2023
Print ISSN 2055-5784
Publisher BMC
Peer Reviewed Peer Reviewed
Volume 9
Article Number 117
DOI https://doi.org/10.1186/s40814-023-01323-0
Keywords Schizophrenia, CBT, MCT, decision-making capacity, patient autonomy, Umbrella trial, supported decision-making, randomised controlled trial

Files

Accelerating the development of a psychological intervention to restore treatment decision-making capacity in patients with schizophrenia-spectrum disorder: study protocol for a multi-site, assessor-blinded, pilot Umbrella trial (the DEC:IDES trial) (supp (960 Kb)
Document


Accelerating the development of a psychological intervention to restore treatment decision-making capacity in patients with schizophrenia-spectrum disorder: a study protocol for a multi-site, assessor-blinded, pilot Umbrella trial (the DEC:IDES trial) (2.2 Mb)
PDF

Publisher Licence URL
http://creativecommons.org/licenses/by/4.0/





You might also like



Downloadable Citations