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

NCT04309435 | Unknown DMC

• 4 other identifiers: 1206004HIPS/18/6019/SS/006919/WA/0155
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

schizophrenia; psychosis; umbrella trial; decision-making capacity; self-esteem; self-stigma; jumping to conclusions

Outcome Measures

Primary Outcomes (2)

• Number of participants recruited and randomised

  This primary outcome relates to achieving the recruitment target (N=60). This will be defined as the overall number of participants recruited and randomised during the recruitment window, divided by the recruitment target.

  Duration of recruitment window (12 months)

• MacArthur Competence Assessment Tool for Treatment (MacCAT-T)

  This primary outcome refers to data completion rates at 8-weeks post-randomisation (end of treatment) on the MacCAT-T (anticipated primary outcome for a future trial). Data completion here refers to the number of participants completing MacCAT-T assessments at week 8 divided by the number of participants randomised. The MacCAT-T assesses participants on 4 domains: (i) Understanding scored 0-6 (3 items); (ii) Reasoning scored 0-8 (4 items); (iii) Appreciation scored 0-4 (2 items); and (iv) Expressing a choice scored 0-2 (1 items). Higher scores indicate greater current ability in each domain.

  Week 8 (end of treatment)

Secondary Outcomes (18)

• MacArthur Competence Assessment Tool for Treatment (MacCAT-T)

  Week 24 (variable follow-up)

• Rosenberg Self Esteem Scale (RSE)

  Weeks 0, 8 and 24 (variable follow-up)

• Semi-structured Interview Measure of Stigma (SIMS)

  Weeks 0, 8 and 24 (variable follow-up)

• Beads task

  Weeks 0, 8 and 24 (variable follow-up)

• Number of deaths by suicide

  Weeks 8 and 24 (variable follow-up)

Other Outcomes (3)

• Assessment of clinical validity of the MacArthur Competence Assessment Tool for Treatment (MacCAT-T) appreciation sub-scale

  Duration of project (20 months)

• Assessment of clinical validity of the MacArthur Competence Assessment Tool for Treatment (MacCAT-T) overall judgements of capacity

  Duration of project (20 months)

• Participant, collaborator & clinical staff experience of trial

  Duration of project (20 months)

Study Arms (6)

Self-esteem intervention

EXPERIMENTAL

The self-esteem intervention involves 6 x 1-hour therapy sessions, each of which will be provided by a fully trained and supervised psychological therapist over an 8-week period (to allow for cancelled appointments etc). It will involve the following elements: * Engagement and listening * Positive regard and empathy * Collaboration * Development of a shared understanding of low self-esteem (a 'psychological formulation') * Provision of written or audio-visual information relating to low self-esteem * Between-session activity for participant * Provision of structured self-help material relating to low self-esteem * Testing of beliefs related to low self-esteem * Practicing new strategies related to low self-esteem * Development of a shared plan to maintain gains in self-esteem

Behavioral: Self-esteem intervention

Self-esteem control group

PLACEBO COMPARATOR

'Assessment and support' for participants with low self-esteem will also involve 6 x 1-hour sessions with a psychological therapist, over a period of 8 weeks. However, in these meetings, the therapist will work in collaboration with the person to complete a more detailed assessment of factors which help or hinder their decision-making capacity. They will provide engagement, listening, positive regard and empathy, but they will not develop a psychological formulation, nor will they provide the person with information relating to their problems. They will also not provide self-help material, or encourage the person to test their beliefs, practice new strategies or develop a shared plan for the future. Once the trial is over, however, the therapist will offer to meet with the person to share the results of the assessment and develop a psychological formulation. With the participant's consent, this information will also be shared with the clinical team.

Behavioral: Control procedure (assessment only)

Self-stigma intervention

EXPERIMENTAL

The self-stigma intervention involves 6 x 1-hour therapy sessions, each of which will be provided by a fully trained and supervised psychological therapist over an 8-week period (to allow for cancelled appointments etc). It will involve the following elements: * Engagement and listening * Positive regard and empathy * Collaboration * Development of a shared understanding of high self-stigma (a 'psychological formulation') * Provision of written or audio-visual information relating to self-stigma * Between-session activity for participant * Provision of structured self-help material relating to self-stigma * Testing of beliefs related to self-stigma * Practicing new strategies related to self-stigma * Development of a shared plan to maintain reductions in self-stigma

Behavioral: Self-stigma intervention

Self-stigma control group

PLACEBO COMPARATOR

'Assessment and support' for participants with high self-stigma will also involve 6 x 1-hour sessions with a psychological therapist, over a period of 8 weeks. However, in these meetings, the therapist will work in collaboration with the person to complete a more detailed assessment of factors which help or hinder their decision-making capacity. They will provide engagement, listening, positive regard and empathy, but they will not develop a psychological formulation, nor will they provide the person with information relating to their problems. They will also not provide self-help material, or encourage the person to test their beliefs, practice new strategies or develop a shared plan for the future. Once the trial is over, however, the therapist will offer to meet with the person to share the results of the assessment and develop a psychological formulation. With the participant's consent, this information will also be shared with the clinical team.

Behavioral: Control procedure (assessment only)

Jumping to conclusions intervention group

EXPERIMENTAL

The 'jumping-to conclusions' (JTC) intervention involves 6 x 1-hour therapy sessions, each of which will be provided by a fully trained and supervised psychological therapist over an 8-week period (to allow for cancelled appointments etc). It will involve the following elements: * Engagement and listening * Positive regard and empathy * Collaboration * Development of a shared understanding of role of JTC (a 'psychological formulation') * Provision of written or audio-visual information relating to JTC * Between-session activity for participant * Provision of structured self-help material relating to JTC * Testing of beliefs related to JTC * Practicing new strategies related to reducing JTC * Development of a shared plan to maintain reductions in JTC

Behavioral: Jumping to conclusions intervention

Jumping to conclusions control group

PLACEBO COMPARATOR

'Assessment and support' for participants who demonstrate the JTC bias will also involve 6 x 1-hour sessions with a psychological therapist, over a period of 8 weeks. However, in these meetings, the therapist will work in collaboration with the person to complete a more detailed assessment of factors which help or hinder their decision-making capacity. They will provide engagement, listening, positive regard and empathy, but they will not develop a psychological formulation, nor will they provide the person with information relating to their problems. They will also not provide self-help material, or encourage the person to test their beliefs, practice new strategies or develop a shared plan for the future. Once the trial is over, however, the therapist will offer to meet with the person to share the results of the assessment and develop a psychological formulation. With the participant's consent, this information will also be shared with the clinical team.

Behavioral: Control procedure (assessment only)

Interventions

Self-esteem intervention BEHAVIORAL

See relevant study arm for description

Self-esteem intervention

Self-stigma intervention BEHAVIORAL

See relevant study arm for description

Self-stigma intervention

Jumping to conclusions intervention BEHAVIORAL

See relevant study arm for description

Jumping to conclusions intervention group

Control procedure (assessment only) BEHAVIORAL

See relevant study arms for description

Jumping to conclusions control group; Self-esteem control group; Self-stigma control group

Eligibility Criteria

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

You may qualify if:

• aged between 18 and 65 years;
• able to be interviewed and complete the measures;
• diagnosed with a schizophrenia-spectrum disorder (schizophrenia, schizoaffective disorder, delusional disorder, psychosis not otherwise specified, brief psychotic disorder);
• presumed or already judged to have impaired treatment decision-making capacity;
• registered as patient with clinical or social care services

You may not qualify if:

• have a moderate to severe learning disability;
• have psychosis of a predominantly organic origin (e.g. brain injury, physical health condition, epilepsy) or have a primary diagnosis of substance or alcohol use disorder;
• cannot understand English sufficiently to engage in conversation without an interpreter;
• presents with a level of risk to others, including the researchers, that cannot be managed feasibility via suitable adjustments, as judged by Chief Investigator

Sponsors & Collaborators

• Edinburgh Napier University: lead
• King's College London: collaborator
• University of Edinburgh: collaborator
• University of Manchester: collaborator
• Pennine Care NHS Foundation Trust: collaborator
• Lancashire Care NHS Foundation Trust: collaborator
• NHS Lothian: collaborator

Study Sites (3)

Pennine Care NHS Foundation Trust

Ashton-under-Lyne, Greater Manchester, OL6 7SR, United Kingdom

NOT YET RECRUITING

Lancashire and South Cumbria NHS Foundation Trust

Preston, Lancashire, PR5 6AW, United Kingdom

NOT YET RECRUITING

NHS Lothian

Edinburgh, Lothian, EH1 3EG, United Kingdom

RECRUITING

Related Publications (2)

• Hutton P, Taylor CDJ, Kelly J, Emsley R, Vikram A, Alexander CH, McCann A, Saddington D, Eliasson E, Burke J, Harper S, Karatzias T, Taylor PJ, Watson A, Dougall N, Stavert J, O'Rourke S, Glasgow A, Murphy R, Palmer K, Zaidi N, Bidwell P, Pritchard J, Carr L, Woodrow A. Accelerating the development of a psychological intervention to restore treatment decision-making capacity in patients with schizophrenia-spectrum disorder: An umbrella trial. Schizophr Res. 2025 Aug;282:184-197. doi: 10.1016/j.schres.2025.06.018. Epub 2025 Jul 3.

  PMID: 40614350 DERIVED

• Hutton P, Kelly J, Taylor CDJ, Williams B, Emsley R, Alexander CH, Vikram A, Saddington D, McCann A, Burke J, Eliasson E, Harper S, Karatzias T, Taylor PJ, Watson A, Dougall N, Stavert J, O'Rourke S, Glasgow A, Murphy R, Palmer K, Zaidi N, Bidwell P, Pritchard J, Carr L, Woodrow A. 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). Pilot Feasibility Stud. 2023 Jul 8;9(1):117. doi: 10.1186/s40814-023-01323-0.

  PMID: 37422659 DERIVED

Related Links

• The DEC:IDES trial website

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Paul Hutton, ClinPsyD

  Edinburgh Napier University

  STUDY DIRECTOR

Central Study Contacts

Paul Hutton, ClinPsyD

CONTACT

(0044)7514054545; decidestrial@gmail.com

Amanda Woodrow, MA

CONTACT

(0044)7425900165; a.woodrow@napier.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinical research data will be gathered at baseline, post-intervention (week 8) and variable follow-up \[week 24; only those randomised in the first 5 (England) to 8 (Scotland) months\] by research assistants (RAs). RAs will be masked to group allocation to demonstrate to future funders this is achievable in an Umbrella trial. Blind-breaks will be recorded, and minimised using previously successful strategies (e.g., separate offices / diaries).
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study is a pilot/feasibility Umbrella trial, comprising of 3 'interventionist-causal' trials (IC-RCTs).

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 16, 2020
• Study Start: February 22, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2022
• Last Updated: January 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)