Programme Grants for Applied Research (Sep 2024)
Improving the Effectiveness of Psychological Interventions for Depression and Anxiety in Cardiac Rehabilitation: The PATHWAY Research Programme Including 4 RCTs
Abstract
Background Cardiac rehabilitation improves health and quality of life and reduces risk of further cardiac events. Twenty-eight per cent of cardiac rehabilitation patients experience clinically significant anxiety and 19% suffer depression. Such patients are at greater risk of death, further cardiac events and poorer quality of life and use more health care, leading to higher NHS costs. The available psychological treatments for cardiac patients have small effects on anxiety and depression and quality of life; therefore, more effective treatments are needed. Research shows that a thinking style dominated by rumination and worry maintains anxiety and depression. A psychological intervention (metacognitive therapy) effectively reduces this style of thinking and alleviates depression and anxiety in mental health settings. The PATHWAY study evaluated two versions of metacognitive therapy applied in cardiac rehabilitation services. Objectives The primary aim was to improve psychological outcomes for cardiac rehabilitation patients. We evaluated two formats of metacognitive therapy: (1) a group-based face-to-face intervention delivered by cardiac rehabilitation staff (group-based metacognitive therapy) and (2) a paper-based, self-directed intervention (home-based metacognitive therapy). Each was compared with usual cardiac rehabilitation alone in separate randomised controlled trials. Design A randomised feasibility trial (work stream 1) and a full-scale randomised controlled trial (work stream 2) evaluated group-metacognitive therapy, while separate feasibility and full-scale trials (work stream 3 and work stream 3+, respectively) evaluated home-based metacognitive therapy. A cost-effectiveness analysis of group-metacognitive therapy was conducted, along with stated preference surveys and qualitative studies examining patient psychological needs and therapists’ perspectives on metacognitive therapy. Setting Seven NHS cardiac rehabilitation services across the north-west of England. Participants Adults aged ≥ 18 years who met cardiac rehabilitation eligibility criteria, scored ≥ 8 on depression or anxiety subscales of the Hospital Anxiety and Depression Scale, and were able to read, understand and complete questionnaires in English. Interventions Work stream 1 and work stream 2 – a 6-week group-metacognitive therapy intervention delivered by cardiac rehabilitation staff plus usual cardiac rehabilitation compared with usual cardiac rehabilitation alone. Group-metacognitive therapy was delivered once per week for 6 weeks, with each session lasting 90 minutes. Work stream 3 and work stream 3+ – home-based metacognitive therapy plus usual cardiac rehabilitation compared with usual cardiac rehabilitation alone. Home-metacognitive therapy was a paper-based manual that included six modules and two supportive telephone calls delivered by cardiac rehabilitation staff. Main outcome measures The Hospital Anxiety and Depression Scale total score at 4-month follow-up was the primary outcome in all trials. A range of secondary outcomes were also evaluated. Results Our qualitative study with 46 patients across three cardiac rehabilitation services suggested that cardiac rehabilitation patients’ psychological needs were not met by current approaches and that metacognitive therapy might offer an improved fit with their psychological symptoms. The internal pilot feasibility study (work stream 1; n = 54) demonstrated that a full-scale randomised controlled trial was feasible and acceptable and confirmed our sample size estimation. A subsequent full-scale, single-blind randomised controlled trial (work stream 2; n = 332) showed that adding group-based metacognitive therapy to cardiac rehabilitation was associated with statistically significant improvements on the Hospital Anxiety and Depression Scale (primary outcome) in anxiety and depression compared with cardiac rehabilitation alone at 4-month (adjusted mean difference −3.24, 95% confidence interval −4.67 to −1.81, p 70% of participants completed the 4-month follow-up questionnaire. More than half of the patients in both arms attended at least six CR sessions, and 57% of Group-MCT participants completed an a priori defined minimal dose of the intervention likely to produce the benefit of at least four of the six MCT sessions. The addition of MCT to rehabilitation did not negatively impact on CR attendance, and we observed high therapist adherence to the protocol. The trial concluded that Group-MCT is an acceptable and feasible intervention to deliver in CR services. The Trial Steering Committee and NIHR as funder agreed to support the progression to a full-scale RCT of the Group-MCT intervention. No substantive changes were required to the trial procedures; therefore, the pilot and full RCT samples were pooled for final analysis. A total of 332 patients (including 52 from the pilot trial) consented to the full-scale RCT of Group-MCT + CR versus CR alone, with 163 randomly allocated to Group-MCT + CR and 169 randomly allocated to CR alone; 81% returned data at 4-month follow-up. The adjusted group difference on the primary outcome of HADS total score at 4 months significantly favoured Group-MCT + CR [–3.24, 95% confidence interval (CI) –4.67 to –1.81, p < 0.001; SMD 0.52], as did the difference at the 12-month secondary outcome point (–2.19, 95% CI –3.72 to –0.66, p < 0.01; SMD 0.33). Patients in the Group-MCT + CR arm also had lower mean HADS anxiety and depression subscale scores at 4 months (p < 0.001). Differences in anxiety remained statistically significant at 12 months (p < 0.01), but those in depression did not (p = 0.065). Most of the other secondary outcomes also favoured the MCT intervention. Attendance at CR sessions did not differ between trial arms. Over 60% of Group-MCT + CR participants attended four or more of the six MCT intervention sessions. However, Group-MCT did not appeal to some patients, with 40 (25%) of the 163 patients randomised to receive MCT attending no MCT intervention sessions. Home-MCT One hundred and eight CR patients consented to the pilot trial of Home-MCT, with 54 randomised to Home-MCT + CR and 54 randomised to CR alone. The trial recruited to target, with 96% of CR only and 83% of Home-MCT + CR participants completing 4-month follow-up measures. Forty-four per cent of patients in the MCT arm completed a minimally effective dose of more than four out of six modules. Exit questionnaire ratings were good. However, views about telephone support were mixed and the quality of calls was rated low. Home-MCT appeared to be acceptable and feasible to deliver in CR services. The Trial Steering Committee and NIHR as funder agreed to support the progression to a full-scale RCT of the Home-MCT intervention. We submitted a no-additional-cost variation to contract (VTC) on 29 January 2019 to progress WS3 to a full-scale RCT (WS3+). The VTC was awarded on 12 March 2019. No substantive changes were required to the trial procedures; therefore, the pilot sample was pooled with the sample from the full RCT in final analysis. A total of 240 patients (including 108 from the pilot trial) were consented to the full-scale RCT of Home-MCT, with 118 randomly allocated to Home-MCT + CR and 122 randomly allocated to CR alone; 89% returned 4-month follow-up data. The adjusted group difference on the primary outcome of HADS total score at 4 months significantly favoured the MCT + CR arm (−2.64, 95% CI −4.49 to −0.78, p = 0.005; SMD 0.38). Patients in the MCT + CR arm also reported significantly lower mean HADS anxiety and depression scores (p < 0.05). Most other secondary outcomes also favoured the MCT intervention. Attendance at CR sessions did not differ between the trial arms. Over 70% of participants in the Home-MCT arm completed more than four MCT modules, but the intervention did not appeal to some patients; 21 participants (18%) withdrew or were not contactable at 4 months, compared with only one in the CR-alone arm. An investigation of the impact of differential attrition on the findings using last-observation-carried-forward resulted in no changes in statistical significance for the primary outcome and most of the secondary outcomes. In the primary cost-effectiveness analysis, the Group-MCT intervention was dominant, that is cost saving (net cost −219, 95% CI −£1446 to £1007) and health increasing (net QALY 0.015, 95% CI −0.015 to 0.045). However, the CIs are wide and overlap zero, indicating a high level of variability in the data and uncertainty in the estimates. Stated preference research indicated a preference for the inclusion of psychological therapy as part of a programme of CR. Conclusions There is not currently a standardised approach for psychological interventions in CR, and interventions can vary. There is a preference for the inclusion of psychological therapy in rehabilitation. Group-based MCT and Home-MCT were associated with significantly better anxiety and depression outcomes when added to CR compared with CR alone. The implications for health care are (1) MCT could be provided as part of the menu of approaches used in CR and (2) patients could be given the option to choose between group-based or home-based treatment to increase access. The recommendations for future research are (1) implementation studies that assess barriers to and enablers of roll-out in the NHS, (2) studies of longer-term outcomes of home-based MCT and (3) an evaluation of MCT against alternative therapies. Trial registration Work stream 1/work stream 2: NCT02420431 and ISRCTN74643496; work stream 3: NCT03129282; work stream 3+: NCT03999359. The trial is registered with clinicaltrials.gov NCT03999359. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme (NIHR award ref: RP-PG-1211-20011) and is published in full in Programme Grants for Applied Research; Vol. 12, No. 7. See the NIHR Funding and Awards website for further award information.
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