This trial is conducted by a multidisciplinary team of researchers, clinicians, statistician and relatives based across academic institutions and NHS Trusts in the North West of England. The research team are responsible for the content of the intervention and have worked with a design company to produce the toolkit and website. The trial is supported by an independent Trial Steering Committee.
Design
Randomisation, Treatment Allocation and Blinding
This is a stratified randomised controlled trial in which participants are allocated to receive either Treatment As Usual (TAU) or TAU plus the REACT intervention. Randomisation is done using permuted blocks within Trust with block sizes varying randomly, and is carried out by an independent Clinical Trials Unit at The Christie NHS Foundation Trust, Manchester. Assessments are carried out in face-to-face interviews at baseline and at 6 months follow-up. Participants are referred into the study by Care Coordinators or self-referral. Potential participants are contacted by a research assistant (RA1) who presents them with verbal and written information about the study. If they wish to take part, the participant is asked to give written consent. Following this, a baseline interview is conducted to assess eligibility and to complete all the measures. A second research assistant (RA2) then contacts the Clinical Trials Unit and provides information about which Trust the relative is in. They are given the trial allocation by telephone. RA2 contacts the relative by telephone and post to inform them which arm of the trial they have been allocated to. RA2 contacts the relevant support worker who will guide the relative through the intervention and instructs them to arrange the first appointment with the participant. RA2 also arranges the 6 month follow-up interview date. In order to ensure that outcomes are collected blind to the treatment allocation, a letter is sent prior to this interview reminding the participant about the importance of not letting RA1 know which group they were allocated to, and making sure that the REACT toolkit is not visible in the house. This is followed-up with a phone call the day before the interview to check the appointment time is convenient and to reiterate the need to maintain blindness. RA1 conducts all of the follow-up interviews and remains blind to allocation throughout the study. To ensure blindness, all communication between relatives and NHS staff is via RA2. The RAs are housed in separate offices and receive individual supervision. Any instances of unblinding will be recorded (Figure 1).
This study was reviewed and approved by the UK NHS Ethics Committee process (REC ref: 08/H1001/147).
Qualitative evaluation
Qualitative interviews will be used to help us understand how the intervention is used and experienced. Relatives participating in the intervention arm of trial will form the strategic sampling pool and will be invited to take part in lightly structured interviews to explore key domains around their use of and experience of the intervention, focusing on the barriers to using the intervention and potential solutions to overcome these. Recruitment will continue until data saturation is reached (estimate approx 10-15 relatives).
Participants
Inclusion criteria
Three NHS Mental Health Trusts in the North West UK are taking part in this study. Each trust has an Early Intervention Service for Psychosis team which supports young adults who are experiencing symptoms of psychosis for a period of up to 3 years. Participants are relatives, partners or close friends of people currently receiving support from one of these teams. Additional criteria include: first contact with EIS within the last 24 months; sufficient understanding of written and spoken English to be able to use the intervention; aged over 18.
Recruitment and consent
Only relatives who already have direct contact with each EIS, and for whom the service has current contact details are invited to take part in the research. This includes relatives currently on the "family and friends group" lists, currently attending groups, and currently receiving face-to-face input from clinical staff and support workers. No relatives are contacted using details taken from patient medical notes without patient consent. No information is collected about the service user. Therefore, service users will not be required to consent into the study. However, to ensure service users are aware of the study and could invite any of their relatives not currently involved with the service, each service will write to all service users informing them about the study and send them a copy of the relatives' information sheet with a covering letter asking them to pass this to any relatives that they would be happy for us to invite and who they feel may be interested in taking part.
Care Coordinators will be informed about the study in a series of presentations given by the research team. They will be asked to discuss the study with relatives they are working with and to refer any relatives interested in taking part who consent to their details being given to the research team. A series of presentations will also be made to relatives at any service user and care events that happen in the Trusts during the recruitment phase. These will encourage relatives to refer themselves into the study if they wish to take part. A website will also be set up that enables confidential referrals to be made either by Care Coordinators or directly from relatives.
Sample Size
The main aim of the study is to assess the feasibility of the design and intervention. The sample required for this is not based on a formal power calculation but on a pragmatic decision balancing sufficient numbers to be able to identify likely barriers to carrying out a larger scale trial, and cost. We aim to recruit 100 participants which will also allow us to estimate the likely effect size of the intervention on a range of outcome measures.
Outcome measures
Relatives will be assessed on a range of measures at both baseline and follow-up. All measures are conducted in a face-to-face interview.
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1)
The General Health Questionnaire (GHQ-28) [12] is a 28-item version of General Health Questionnaire derived by factor analysis from the full 60-item version. It is used to assess the psychological aspect of quality of life or in the detection of psychiatric distress. Participants indicate whether their current state differs from their usual state, thereby assessing recent changes in state as opposed to long-term traits or illnesses.
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2)
The Family Questionnaire [13] presents participants with a range of symptoms of mental illness that have the potential to pose a problem in family life. It assesses the extent to which each of these symptoms cause the relative concern and how well the relative is able to cope with their concerns.
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3)
The Relationship Quality Scale [14] asks service users and relatives to rate their perception of their relationship with one another on scales of supportiveness and criticism. This measure has been shown to predict outcome for people with severe depression [14] and schizophrenia [15].
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4)
The Brief Illness Perception Questionnaire [16] adapted from the original Illness Perception Questionnaire [17] measures the insight of participants into their relative's illness. Components include the participant's views on the consequences of the illness, comprehension of the illness, knowledge of prognosis, the extent to which they attribute blame, knowledge of potential causes and their own concern and emotional responses to the illness.
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5)
The Herth Hope Index [18] consists of 12 items designed to assess hope in adults in clinical settings.
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6)
The Experience of Caregiving Inventory [19] measures the experience of caring for a relative with a serious mental illness. The 66-items are divided into 10 sub-scales, 8 negative (difficult behaviours, negative symptoms, stigma, problems with services, effects on the family, the need to provide back-up, dependency, loss) and 2 positive (rewarding personal experiences, good aspects of the relationship with the patient).
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7)
The Carer Well-Being and Support Questionnaire [20] measures the experience of carers of people with severe mental health problems. It is designed to cover all aspects of the carer's experience including relationships, roles, financial concerns, physical/emotional health, stigma, worries about safety, their satisfaction with support offered and ease of obtaining information.
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8)
The Relatives' Satisfaction Questionnaire (adapted from CSQ-8 [21]) is used to assess satisfaction with services in both arms of the trial to test the hypothesis that the intervention will lead to an increased level of satisfaction in relatives.
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9)
The Treatment As Usual Checklist is a short questionnaire designed for this study to assess the amount and type of support that participants have received from the Early Intervention Service while in the Treatment as Usual arm of the trial.
The Intervention
Development
During the first year of the study a CBT oriented, supported self-management package for relatives of people with a recent onset psychosis was developed and finalised. First, a systematic review of studies of psychological interventions for relatives of people with recent onset psychosis was conducted. This identified the key components of effective interventions and distinguished them from those of ineffective interventions. Second, relatives of people who have experienced psychosis were invited to take part in focus groups to allow in-depth analysis of relatives' views and experiences of a self-management approach. The questions asked, focussed around (i) their experiences of self-management approaches; (ii) preferred format (or "health technology"); (iii) what support they would like to receive; (iv) perceived barriers. Further details on the findings of this study are reported elsewhere [22]. Finally, participants from the focus groups were invited to be part of an Intervention Reference Group that was involved in an iterative process of feedback and development to produce the supported self-management package. An independent design company was used to style the package professionally and an independent publisher was used to produce the required number of intervention packs (Figure 2).
Features
The finalised package is modular in design, providing a range of sections or "tools" that relatives can draw on as needed. These modules have been designed to operate independently of each other and contain topics such as essential information about psychosis, ways to identify and challenge beliefs that may cause distress, ways to manage common difficulties faced by relatives, and coping strategies to aid recovery for both the relative and the person with psychosis. The package is also well referenced to guide people to existing support in related domains such as legal advice, advocacy, charities etc. Building on previous research in self-management for depression, the intervention also gives relatives the opportunity to incorporate their personal experience into the process, to situate this intervention within a context of previous experiences, build on existing self-management strategies to facilitate engagement, and highlight the self as the key agent of change [23].
The intervention has been designed to be used by relatives in their own homes and at their own convenience. As such, it has been produced as a hard copy format and as a website and participants are able to choose to use either or both of these formats. Both versions contain the same information and resources. Support is provided by an NHS support worker trained and supervised by the research team. The support worker will offer an initial face-to-face introductory session in which they guide the relative through the materials and how to use them. Following this, support in using the package will be offered via email or telephone depending on the relatives' preference.
Analysis
Quantitative data
Analysis of outcomes will be carried out using simple descriptive statistics, tabulation and simple graphical display. Tests of statistical significance will be carried out using Student's t-test (quantitative outcomes) or Pearson chi-square (binary outcomes). Further analyses to allow for pre-randomisation (baseline) measures and to investigate the effects of missing outcomes will be carried out using analyses of covariance or logistic regression, respectively.
Qualitative data
Analysis will be carried out by a multidisciplinary team of psychologists, nurses, relatives and researchers. To ensure that the analysis is grounded in the data, rather than reflecting pre-existing ideas, analysis will occur in parallel with data collection so that aspects of the developing analysis can be tested in subsequent interviews. Categorisation and thematic analysis of the data will be developed by cycling between the analysis and transcripts and periodic 'testing' of the analysis by discussion amongst the entire team so as to meet accepted criteria for trustworthiness of the analysis. In addition, we will assess the validity of the final analysis by examining coherence and catalytic validity, which is essentially the utility of the analysis in identifying implications for clinical practice and research that can be tested.