Work stream 3: the development and evaluation of Home-MCT

Work stream 3 overview

BACPR suggests that CR should employ a menu-based approach to CR, allowing a choice of home-based programmes.2 Although CR offers home-based CR programmes, this has not been applied to psychological support, which has predominantly been delivered and evaluated in face-to-face formats.48

Home-based psychological support may increase access to psychological help, especially for CR patients who may not be able or willing to attend face-to-face treatment or may be returning to work. Current self-help psychological therapies for cardiac patients are focused on applying relaxation techniques and CBT7 and are limited in efficacy.48–50 As current home-based psychological options have variable effects, there is room to develop more effective alternatives.

While MCT has demonstrated efficacy in face-to-face delivery, a self-help version of MCT has yet to be evaluated. We therefore set out to develop and evaluate the feasibility and acceptability of home-based MCT.

Work stream 3 aims

1. Develop a home-based metacognitive intervention (Home-MCT) for CR patients with depression and/or anxiety.
2. Establish the acceptability and feasibility of integrating Home-MCT into the CR pathway.
3. Establish provisional evidence of the effectiveness and cost-effectiveness of Home-MCT.
4. Obtain qualitative data to help refine the presentation and delivery or Home-MCT for a full-scale trial.
5. Obtain data from a stated preferences survey about participants’ relative preferences, utility and WTP for components of the intervention to inform the design of a full-scale trial.
6. Collect data on patient variables and outcome measures to inform the design of a full-scale trial.

Methods

The PATHWAY Home-MCT feasibility study is a multicentre RCT with 4- and 12-month follow-up comparing home-based MCT plus usual CR (intervention) with usual CR alone (control). The trial received full ethics approval from the Northwest – Greater Manchester West Research Ethics Committee (reference 16/NW/0786, IRAS ID 186990) and was registered with a clinical trials database (ClinicalTrials.gov, identifier number NCT03129282). Participants were recruited from two NHS CR services (Bolton NHS Foundation Trust and Aintree University Hospitals NHS Foundation Trust). For further details of the trial protocol, including participant assessment and recruitment, see Wells et al.28

Trial population

Inclusion criteria were as follows:

1. Fulfil Department of Health and Social Care and/or BACPR CR eligibility criteria. Thus, the patient was to have at least one of the following: acute coronary syndrome, revascularisation, stable heart failure, stable angina, implantation of cardioverter defibrillators/cardiac resynchronisation devices, heart valve repair/replacement, heart transplantation and ventricular assist devices, adult congenital heart disease, other atypical heart presentation
2. A score of ≥ 8 on the anxiety and/or depression subscales of the HADS (screening HADS)35
3. Minimum of 18 years old
4. A competent level of English-language skills (able to read, understand and complete questionnaires in English)

Participants were excluded if they met any of the following criteria:

1. Cognitive impairment that precludes informed consent or ability to participate
2. Acute suicidality
3. Active psychotic disorders (i.e. two or more of the following: delusions, hallucinations, disorganised speech, grossly disorganised or catatonic behaviour, negative symptoms)
4. Current drug/alcohol abuse (a maladaptive pattern of drinking, leading to clinically significant impairment or distress)
5. Concurrent psychological intervention for emotional distress that is not part of usual care
6. Antidepressant or anxiolytic medications initiated in the previous 8 weeks
7. Life expectancy of < 12 months

Self-help metacognitive therapy (Home-MCT)

Home-MCT is a self-help paper manual that consists of six modules. Modules focus on developing a case formulation, developing new strategies to regulate worry and rumination, and challenging metacognitive beliefs that maintain maladaptive patterns of thinking. In addition, participants received three telephone support calls lasting up to 30 minutes each. Call 1 was introductory; during this call, the manual and format were explained to patients and calls 2 and 3 were scheduled. Calls 2 and 3 were made after the completion of modules 2 and 4 and focused on reviewing the key learning points and providing support and guidance on the modules and implementing MCT strategies. Support calls followed a structured script, and staff were reminded that their role was to provide support and guidance on completing Home-MCT. Home-MCT was offered in addition to usual CR.

Development of Home-MCT

The treatment manual was developed by the PATHWAY chief investigator (Adrian Wells) and based on the Group-MCT manual. Before the Home-MCT manual was used in the feasibility trial, the manual and telephone support calls were tested with our PPI group, and after this, focus groups were conducted to review the manual and calls.

During the focus group, PPI members noted that the manual was easy to use and modules were easily to follow and flexible and encouraged adherence to the intervention. However, they felt that the size of the manual may deter patients from using it.

Patient and public involvement feedback on individual modules was as described below.

Piloting the manual with the PPI group provided important insight into patient experience of the intervention and the timing and content of telephone support calls prior to participant recruitment. This resulted in alterations to the manual, including adding information on what to expect from the intervention and what to do when the manual was received by post, emphasising that patients could complete the different modules at their own pace, increasing simplicity of instructions for completing the homework sections, and making a clearer differentiation between anxiety and stress. Amendments were also made to the telephone support scripts. Feedback from the PPI group was addressed prior to trialling Home-MCT, and PPI members were informed of how all the changes were addressed.

Analysis

With a view to the potential for the study to act as an internal pilot for a subsequent definitive trial (i.e. the data would be combined with subsequent data if the trial were extended and no changes were made to the methods), data analysis was restricted so that it was primarily descriptive, with no between-group analysis of outcome measures, thereby ensuring that masking to treatment allocation would be maintained if the trial were extended.

Acceptability of adding Home-MCT to usual CR was assessed by:

1. Recruitment into the study (number of patients agreeing to participate out of those approached, and number recruited per month)
2. Withdrawal or drop-out by the primary end point of 4 months and by 12-month follow-up (attrition rates)
3. Numbers of MCT modules completed (including time spent on each module)
4. Number of CR sessions attended

The feasibility of conducting a full trial was assessed by:

1. Completion of follow-up questionnaires (proportions of missing values)
2. Ability of the outcome measures to discriminate between patients (range of scores; floor or ceiling effects)
3. Re-estimation of the sample size for a definitive trial based on the findings of this study

Unlike the WS1 pilot, specific thresholds for progression to a full RCT were not defined for WS3, as our original protocol was not designed to continue to a full RCT within the research programme. However, we found ourselves in the position of being able to progress to a full-scale evaluation at no extra cost and did so following consultation with the TSC and NIHR under a ‘variation to contract’. The results of the full trial (WS3+) are reported later in this report.

Results (work stream 3)

Participant overview

Between 1 April 2017 and 26 February 2018, 632 patients were referred to CR services, of whom 200 (31.6%) were eligible to take part. One hundred and eight patients (69 male and 39 female) agreed to participate and were consented and randomised to the study. Patients had a mean age of 59.9 years (standard deviation 9.7 years, range 40–84 years).

Acceptability and feasibility trial of Home-MCT

The study achieved a recruitment rate of approximately 10.8 patients per month.

Retention at 4-month follow-up was > 80% for both arms. In the control arm, 52 (96.3%) patients returned 4-month follow-up data, 2 patients died and no patients withdrew from the study. In the intervention arm, 45 (83.3%) patients returned follow-up data, 4 patients withdrew, 4 patients did not return data, and 1 patient died. Attrition was therefore higher in the MCT + CR arm, at 16.7% compared with 3.7% in the CR-alone arm. Retention remained high at 12 months, but with a similar difference between the arms, with 90.7% of control and 81.5% of intervention participants returning follow-up data.

All questionnaires demonstrated a good range of observed scores, covering the majority of the possible score range, with little in the way of floor or ceiling effects.

Attendance at CR was high in both arms; 89% of CR-alone patients attended CR exercise classes and 85% attended educational seminars on health-related topics. Only 11% did not attend any CR exercise sessions and 15% did not attend any educational seminars. In the Home-MCT + CR arm, 80% of patients attended CR exercise classes and 78% of patients attended educational seminars. A higher proportion of intervention group participants did not attend exercise sessions, at 20%, and 22% did not attend educational seminars.

Information on engagement with the Home-MCT manual was collected via an end-of-study questionnaire mailed to participants, which had a 69% response rate. In total, 72.7% of patients who returned the end-of-study questionnaire completed four or more of the six modules, although owing to attrition these were just 45.3% of all Home-MCT patients still alive at 4 months. Although most patients reported completing a module in 60 minutes, individual times for doing this varied, ranging from 40 to 105 minutes.

Among those who returned the questionnaire, Home-MCT demonstrated high credibility. After completing the manual, patients were assessed on how user-friendly they found Home-MCT. Home-MCT was rated highly, with patients stating that they found the manual easy to use and understand (median rating of 80 out of 100), that the homework was easy to follow (median rating of 85 out of 100), and that the exercise SpACE was easy to use (median rating of 90 out of 100). When patients were asked if they found that they needed the telephone support calls, results were mixed: 40% said they did not need the support calls, while 40% stated they did. No adverse events were reported.

Verification of estimated sample size

Under assumptions of 20% attrition and a 0.5 correlation between baseline and 4-month follow-up, we provisionally estimated that a total recruitment sample of 246 patients would be required for a definitive trial, subject to revision based on the findings of this feasibility study. In the event, this feasibility study had an overall attrition rate of 10% at 4 months and a baseline-to-follow-up correlation of 0.58. However, there was evidence of greater attrition in the Home-MCT group at 17%, so for conservative reasons we chose to retain our original sample size estimate for a main trial.

Summary of findings of work stream 3

Overall, Home-MCT was found to be an acceptable and feasible addition to CR. No adverse events were reported in either trial arm. These results suggested that we could progress to a full-scale RCT to evaluate the efficacy of Home-MCT. The full trial would also provide a more definitive evaluation of the tendencies seen in the pilot for retainment in the trial and attendance at usual care to be somewhat lower among those offered Home-MCT. The success of the feasibility study supported a VTC to extend recruitment to a full-scale RCT.

Stated preference survey

Introduction

A pilot stated preference survey, using a DCE design, was conducted to explore the preferences of participants in the Home-MCT feasibility study for attributes of a psychological therapy intervention, relevant to home-based care, delivered in CR. The objectives were to evaluate the feasibility of preference research, estimate the sample size needed for a full study and explore preliminary preferences for included attributes. The paper has been published.33

Methods

Following a review of qualitative feedback, PPI feedback and iterative discussion with the trial team, attributes and levels were selected for the DCE. A fractional factorial design was chosen, using a published design catalogue (http://neilsloane.com/oadir/oa.16.5.4.2.txt) and modulo arithmetic.47,51 Participants were asked to choose their preferred scenario from two hypothetical options, and then whether they would choose this scenario or no psychological therapy (opt-out). Data were analysed using individual choice responses as the dependent variable in the model with a conditional logit using maximum likelihood estimation.47 Results were used to estimate the sample size that would be required to calculate significant preference coefficients in a full study, generated for D-efficient and Bayesian designs in the experimental design software Ngene (Choice-Metrics, Sydney, NSW, Australia).52

Results

The survey had a 39% response rate (n = 35/89). The conditional logistic regression identified significant results for two factors: participants disliked having no information about the therapy before it started and favoured lower costs to the NHS. Participants appeared to favour home-based therapy, with reduced waiting times, and online or smartphone-assisted therapy, although these results were not statistically significant. Significant positive constants for therapy options suggest that participants highly valued receiving therapy (compared with receiving no therapy). It was estimated that a sample size of around 370 would be needed to identify significant coefficients for most attributes.

Conclusions

The pilot study demonstrates the feasibility of a DCE in this group; it identifies potential attributes and levels and estimates the sample sizes needed for a full study. Preliminary evidence indicates that sampled participants tended to prefer home-based psychological therapy in CR and wanted to receive information before initiating therapy. Limitations include the sample size and the lack of diversity in the sample, as well as the potential impact of the COVID-19 pandemic, which may have influenced participant responses and subsequently the elicited preferences. Results are limited owing to the pilot design, and further research is needed to increase the robustness of the findings.