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Statistical analysis plan for a pragmatic randomised controlled trial comparing enhanced acceptance and commitment therapy plus ( +) added to usual aftercare versus usual aftercare only, in patients living with or beyond cancer: SUrvivors' Rehabilitation Evaluation after CANcer (SURECAN) trial
Background
The aim of the SURECAN trial is to evaluate a person-centred intervention, based on Acceptance and Commitment Therapy (ACT Plus ( +)), for people who have completed treatment for cancer with curative intent, but are experiencing poor quality of life. We present the statistical analysis plan for assessing the effectiveness and cost-effectiveness of the intervention in improving quality of life 1 year post randomisation.
Methods and design
SURECAN is a multi-centre, pragmatic, two-arm, partially clustered randomised controlled superiority trial comparing the effectiveness of ACT + added to usual care with usual aftercare. The target sample size is 344 (172 per arm), randomised centrally in a 1:1 ratio.
Results
The primary outcome is the total score of the Functional Assessment of Cancer Therapy scale-General (FACT-G) at 52 weeks, analysed using a partially nested mixed-effects model with heteroskedastic error terms. Secondary outcomes include scores at 16 and 52 weeks: FACT-G subscales; Fear of Cancer Recurrence Inventory (FCR4); positive and negative Impact of Cancer scales (IOCv2); Hospital Anxiety and Depression scale (HADS); Chalder Fatigue Scale (CFQ); and physical activity, measured on a modified version of the Godin scale. Health economic analyses will determine the incremental cost-effectiveness ratio (ICER) in terms of quality-adjusted life years (QALYs) derived from the Euroqol 5-Dimension 5-Level (EQ-5D-5L) compared to usual care at 52 weeks.
Discussion
This manuscript is the statistical analysis plan (SAP) and economic evaluation for the SURECAN trial. Any exploratory or post hoc analyses will be identified as such in the respective analysis report.
Trial registration
The trial was prospectively registered. ISRCTN: ISRCTN67900293. Registered on 09 December 2019.
Journal Article
Feasibility, Acceptability, and Preliminary Efficacy of Acceptance Commitment Therapy for Adults Living With Inflammatory Bowel Disease and Distress
Background
The bidirectional relationship between inflammatory bowel disease (IBD) flare-ups and depression/anxiety symptoms has prompted investigations into psychotherapy to improve health-related quality of life (HRQoL) by targeting depression and anxiety. Acceptance commitment therapy (ACT) is effective in improving symptoms of depression and anxiety in people with chronic diseases, yet minimal research has examined ACT’s effectiveness for IBD. This study examines the feasibility, acceptability, and preliminary efficacy of the ACTforIBD program, an online program codesigned with consumers to deliver ACT to those with IBD.
Methods
Adults with IBD and symptoms of mild-moderate distress were randomized to ACTforIBD or an active control (psychoeducation) condition. Participants completed 8 weekly, 1-hour sessions, 4 of which were therapist facilitated. Feasibility was based on recruitment and retention and acceptability was derived from postprogram satisfaction measures. Preliminary efficacy was determined by group differences in rate of change in study outcomes from baseline to postprogram.
Results
Of 62 participants (89% women, 11% men; mean age 33 years), 55 completed the program (ACTforIBD: n = 26 [83.9%]; active control: n = 29 [93.5%]). Adherence and acceptability were high in the ACTforIBD group, with 80% of participants completing all self-directed modules and 78% of participants expressing satisfaction with the program. Significant and marginally significant group × time interactions were found for anxiety symptoms (b = -1.89; 95% confidence interval, -3.38 to -0.42) and psychological HRQoL (b = -0.04; 95% confidence interval, -0.07 to 0.01), showing decreased anxiety and increased psychological HRQoL in the intervention group.
Conclusions
ACTforIBD is feasible, acceptable, and improved anxiety symptoms, and psychological HRQoL. This highlights the need for a full-scale randomized controlled trial to further examine the program’s efficacy.
Journal Article
Cost‐effectiveness of acceptance and commitment therapy for people living with motor neuron disease, and their health‐related quality of life
Background Given the degenerative nature of the condition, people living with motor neuron disease (MND) experience high levels of psychological distress. The purpose of this research was to investigate the cost‐effectiveness of acceptance and commitment therapy (ACT), adapted for the specific needs of this population, for improving quality of life. Methods A trial‐based cost–utility analysis over a 9‐month period was conducted comparing ACT plus usual care (n = 97) versus usual care alone (n = 94) from the perspective of the National Health Service. In the primary analysis, quality‐adjusted life years (QALYs) were computed using health utilities generated from the EQ‐5D‐5L questionnaire. Sensitivity analyses and subgroup analyses were also carried out. Results Difference in costs was statistically significant between the two arms, driven mainly by the intervention costs. Effects measured by EQ‐5D‐5L were not statistically significantly different between the two arms. The incremental cost‐effectiveness was above the £20,000 to £30,000 per QALY gained threshold used in the UK. However, the difference in effects was statistically significant when measured by the McGill Quality of Life‐Revised (MQOL‐R) questionnaire. The intervention was cost‐effective in a subgroup experiencing medium deterioration in motor neuron symptoms. Conclusions Despite the intervention being cost‐ineffective in the primary analysis, the significant difference in the effects measured by MQOL‐R, the low costs of the intervention, the results in the subgroup analysis, and the fact that ACT was shown to improve the quality of life for people living with MND, suggest that ACT could be incorporated into MND clinical services.
Journal Article
Experiencing ACT from the inside out : a self-practice/self-reflection workbook for therapists
\"From leading acceptance and commitment therapy (ACT) practitioners, this experiential training workbook invites therapists to broaden and strengthen their ACT skills through deep engagement with ACT theory and techniques. Everyone from beginning therapists to seasoned ACT practitioners can enhance their work through self-practice/self-reflection (SP/SR), a cutting-edge, evidence-based training method. Through a systematic process, readers learn how to effectively apply ACT to a personal or professional challenge and reflect on the experience. Fifteen step-by-step modules are illustrated with vivid examples from the authors' own SP/SR journeys. In a large-size format for easy photocopying, the book includes 14 reproducible worksheets and over 3 hours of audio exercises. Purchasers get access to a companion website where they can download the audio exercises, as well as printable copies of the worksheets\"-- Provided by publisher.
Book
Cost-effectiveness and cost-utility of an Acceptance and Commitment Therapy intervention vs. a Cognitive Behavioral Therapy intervention for older adults with anxiety symptoms: A randomized controlled trial
A previous randomized controlled trial in older adults with anxiety symptoms found no differences between a brief blended Acceptance and Commitment Therapy (ACT) intervention and brief face-to-face Cognitive Behavior Therapy (CBT) regarding anxiety symptom severity at posttreatment and 12-month follow-up. A health-economic evaluation comparing these interventions has not yet been conducted.
This study examined the one-year cost-effectiveness and cost-utility of blended ACT compared to face-to-face CBT for older adults with anxiety symptoms.
The economic evaluation was embedded in a randomized controlled trial comparing blended ACT to CBT in 314 older adults with mild to moderately severe anxiety symptoms. Data were collected at baseline and 3, 6 and 12 months post baseline. For the cost-effectiveness analysis, treatment response was defined as a reliable improvement in anxiety symptom severity (measured with the Generalized Anxiety Disorder-7) between baseline and 12-month follow-up. To assess cost-utility, quality-adjusted life years (QALYs) were computed using EuroQol-5 Dimensions-5 Levels-5 utility scores. Analyses took the societal perspective, including both healthcare costs and productivity costs. Incremental cost-effectiveness ratios were calculated using 2500 bootstraps of seemingly unrelated regression equations of costs and effects. Sensitivity analyses were performed to assess the robustness of the findings.
Differences between the blended ACT group and CBT group in treatment response and QALYs were statistically insignificant and clinically irrelevant. The ACT intervention was associated with an average per-participant cost reduction of €466 ($593) compared to CBT, which resulted from lower productivity costs in the blended ACT group. From a healthcare perspective, the ACT intervention was associated with higher costs (by €71 ($90)) than CBT.
The results do not indicate that from a health-economic perspective blended ACT should be preferred over CBT in the treatment of older adults with anxiety symptoms. The findings support a model of shared decision making, where clinicians and patients collaboratively decide on the preferred intervention, based on ethical-medical, practical and personal considerations.
Netherlands Trial Register: TRIAL NL6131 (NTR6270); https://www.trialregister.nl/trial/6131.
Journal Article
Acceptance and commitment coaching : distinctive features
\"Jon Hill and Joe Oliver introduce the Acceptance and Commitment Coaching (ACC) model with clarity and accessibility, defining it as an approach that incorporates mindfulness and acceptance, focusing on committed, values-based actions to help coaching clients make meaningful changes to their lives\"-- Provided by publisher.
Book
Trial-based economic evaluation of the BrainACT study: acceptance and commitment therapy for anxiety and/or depressive symptoms after acquired brain injury
IntroductionFollowing acquired brain injury (ABI), individuals often experience anxiety and/or depressive symptoms. BrainACT is an adapted form of Acceptance and Commitment Therapy (ACT) tailored to this target group. The current study is a trial-based health-economic evaluation comparing BrainACT to a psychoeducation and relaxation control treatment.MethodsAn economic evaluation from a societal perspective was conducted in the Netherlands alongside a multicenter randomized controlled two-armed parallel trial including 72 participants. A cost-utility and cost-effectiveness analysis was conducted where incremental costs, quality-adjusted life-years (QALYs), and anxiety/depression (Hospital Anxiety and Depression Scale (HADS) score) were collected and presented over a 1-year follow-up period. Bootstrapping, scenario, and subgroup analyses were performed to test the robustness of the results.ResultsThe BrainACT arm reported non-significant lower total costs (incremental difference of €−4,881; bootstrap interval €−12,139 to €2,330) combined with significantly decreased anxiety/depression (HADS) (3.2; bootstrap intervals 0.7–5.7). However, the total QALYs were non-significantly lower (−0.008; bootstrap interval −0.060 to 0.042) for BrainACT. The probability of the intervention being cost-effective was 86 percent at a willingness-to-accept threshold of €50,000/QALY. The scenario and subgroup analyses confirmed the robustness of the results.ConclusionBrainACT may be a more cost-effective alternative to a psychoeducation and relaxation intervention for anxiety and/or depressive symptoms following ABI. Despite limitations, BrainACT appears to be a promising addition to treatment options in the Netherlands. Further research is needed to validate these findings, and consideration should be given to implementing BrainACT in Dutch clinical settings with ongoing monitoring.
Journal Article