DEcision-making Capacity: Intervention Development & Evaluation in Schizophrenia-spectrum Disorder: The DEC:IDES Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Edinburgh Napier University
- Enrollment
- 60
- Locations
- 3
- Primary Endpoint
- MacArthur Competence Assessment Tool for Treatment (MacCAT-T)
Study Overview
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.
Detailed Description
- BACKGROUND & RATIONALE FOR STUDY
'Treatment decision-making capacity' ('capacity'), is defined as the ability to understand, appreciate, and retain information relating to a proposed treatment, weigh that information and communicate a choice. Capacity is now a pivotal concept in healthcare and law, and clinicians are legally obliged to respect patient autonomy where capacity exists.
Capacity has been referred to as the 'gatekeeper of autonomy'. When it is lost there is a legal and ethical imperative for clinicians to work to support its return and retention. However in their scrutiny of capacity-law implementation, the United Kingdom (UK) House of Lords concluded: "Our evidence suggests that (supported decision-making) is rare in practice" and The United Nations Committee on the Convention on the Rights of Persons with Disabilities (UNCRPD) advised that greater provision of supported decision-making is essential if the UK is to be compliant with Article 12 of the Convention on Human Rights.
Despite the importance and legal obligation to support capacity there is a lack of evidence on how to do this effectively. A recent systematic review and meta-analysis synthesised evidence from 23 studies on capacity in psychosis and found there were no randomised controlled trials (RCTs) of supported decision-making interventions. Psychiatrists view the evidence in this area as weak, and the National Institute for Health and Clinical Excellence (NICE) have called for RCTs to enhance evidence in this area. Anticipating this, over the last 5 years the research team, comprising clinicians, legal experts and researchers, have produced 5 systematic reviews and meta-analyses addressing various aspects of decision-making capacity in psychosis, and 5 clinical studies. These indicate that a lack of capacity is likely to stem from interactions between cognitive, emotional and social factors, the effects of which are moderated by a person's awareness of them. This model specifically predicts that 'self-stigma', low self-esteem, and the 'jumping to conclusions' (JTC) bias are likely to have large, additive adverse effects on their capacity.
Psychological interventions that selectively reduce each of these hypothesised 'causal mechanisms' have already been developed. The next stage of this research is therefore to conduct 'interventionist-causal RCTs' (IC-RCTs) to examine whether these interventions can also cause improvements in capacity. Recommended to accelerate the development of treatments for psychotic symptoms such as delusions, these sophisticated trials are capable of producing invaluable information on what causes and improves impaired capacity. If the trials are run consecutively, people with psychosis could wait 10-15 years for definitive findings and would involve setting up several costly trial infrastructures to support each trial.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Masking Description
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).
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Self-esteem intervention
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
Intervention: Self-esteem intervention (Behavioral)
Self-esteem control group
'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.
Intervention: Control procedure (assessment only) (Behavioral)
Self-stigma intervention
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
Intervention: Self-stigma intervention (Behavioral)
Self-stigma control group
'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.
Intervention: Control procedure (assessment only) (Behavioral)
Jumping to conclusions intervention group
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
Intervention: Jumping to conclusions intervention (Behavioral)
Jumping to conclusions control group
'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.
Intervention: Control procedure (assessment only) (Behavioral)
Outcomes
Primary Outcomes
MacArthur Competence Assessment Tool for Treatment (MacCAT-T)
Time Frame: Week 8 (end of treatment)
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.
Number of participants recruited and randomised
Time Frame: Duration of recruitment window (12 months)
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.
Secondary Outcomes
- Rosenberg Self Esteem Scale (RSE)(Weeks 0, 8 and 24 (variable follow-up))
- Number of participants attempting suicide(Weeks 8 and 24 (variable follow-up))
- Number of participants experiencing suicidal crisis without suicide attempt(Weeks 0, 8 and 24 (variable follow-up))
- Brief Core Schema Scale (BCSS)(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))
- Calgary Depression Scale for Schizophrenia (CDSS)(Weeks 0, 8 and 24 (variable follow-up))
- Beck Anxiety Inventory (BAI)(Weeks 0, 8 and 24 (variable follow-up))
- Number of participants experiencing severe symptom exacerbation(Weeks 8 and 24 (variable follow-up))
- Number of deaths not related to suicide(Weeks 8 and 24 (variable follow-up))
- Adverse Experiences in Psychotherapy (AEP)(Weeks 8 and 24 (variable follow-up))
- Questionnaire about the Process of Recovery (QPR)(Weeks 0, 8 and 24 (variable follow-up))
- Positive and Negative Syndrome Scale (PANSS)(Weeks 0, 8 and 24 (variable follow-up))
- Client Service Receipt Inventory (CSRI)(Weeks 0, 8 and 24 (variable follow-up))
- Number of blind-breaks(Weeks 0, 8 and 24 (variable follow-up))
- MacArthur Competence Assessment Tool for Treatment (MacCAT-T)(Week 24 (variable follow-up))
- Schizophrenia Quality of Life Scale (SQoLS)(Weeks 0, 8 and 24 (variable follow-up))
Investigators
Dr Paul Hutton
Associate Professor
Edinburgh Napier University