Lessons Learned From Transition of an In-Person to a Virtual Randomized Controlled Trial for Weight and Fitness Concerns in Active-Duty Service Members: Survey Study.

BACKGROUND: This paper describes and discusses the transition of and modifications to a weight management randomized controlled trial among active-duty military personnel from an in-person to a virtual format as a result of the COVID-19 pandemic. The original pragmatic cohort-randomized controlled trial was designed to compare the effectiveness of an 8-week group weight management program, ShipShape, to a version of ShipShape enhanced with acceptance and commitment therapy. OBJECTIVE: The objective of our study was to assess potential differences between in-person and virtual participation in participants' demographics, motivation, confidence, credibility, expectations, and satisfaction with the interventions; we also examined the pragmatics of the technology and participants' experiences in virtual-format intervention groups. METHODS: A total of 178 active-duty personnel who had failed or were at risk of failing their physical fitness assessment or were overweight or obese were enrolled in the study. In-person (n=149) and virtual (n=29) participants reported demographics, motivation, confidence, credibility, expectations, and satisfaction. Interventionists recorded attendance and participation in the group sessions. Independent-sample 2-tailed t tests and chi-square tests were used to compare the characteristics of the in-person and virtual participants. Pragmatics of the technology and participants' experiences in the virtual format were assessed through surveys and open-ended questions. RESULTS: Participants were 29.7 (SD 6.9) years old on average, 61.8% (110/178) female, and 59.6% (106/178) White and had an average BMI of 33.1 (SD 3.9) kg/m2. Participants were highly motivated to participate and confident in their ability to complete a weight management program. A total of 82.6% (147/178) of all participants attended 5 of the 8 sessions, and participation was rated as "excellent" by interventionists in both formats. The interventions were found to be credible and to have adequate expectations for effectiveness and high satisfaction in both formats. There were no differences between in-person and virtual participants in any of these metrics, other than interventionist-rated participation, for which virtual participants had significantly higher ratings (P<.001). Technical satisfaction with the virtual sessions was rated as "good" to "very good," and participants were satisfied with the content of the virtual sessions. A word cloud of responses identified "mindfulness," "helpful," "different," "food," "binder," and "class" as concepts the virtual participants found most useful about the program. CONCLUSIONS: Modifications made in response to the COVID-19 pandemic were successful, given the recruitment of active-duty personnel with similar demographic characteristics, attendance levels, and indicators of credibility, expectancy, and satisfaction in the virtual format and the in-person format. This successful transition provides support for the use of virtual or digital weight management interventions to increase accessibility and reach among highly mobile active-duty personnel. TRIAL REGISTRATION: ClinicalTrials.gov NCT03029507; https://clinicaltrials.gov/ct2/show/NCT03029507.

Participants' experiences of mental health during a COVID-19 tailored ACT-based behavioural weight management intervention: a qualitative study.

PURPOSE: We aimed to explore participants' experiences of mental health during an acceptance and commitment therapy (ACT)-based guided self-help intervention to support weight management in adults with overweight or obesity during the COVID-19 pandemic (SWiM-C: Supporting Weight Management during COVID-19). METHODS: We conducted semi-structured telephone interviews with twenty participants and used reflexive thematic analysis to identify patterns of meaning across the dataset relevant to mental health. RESULTS: Four themes were conceptualized: i) Mental health changes associated with SWiM-C, ii) External factors negatively impacted mental health and intervention engagement, iii) Use and impact of coping responses, and iv) Intervention preferences based on psychological needs. CONCLUSIONS: Findings suggest that participants were exposed to multiple factors, both related to and external to the intervention, that negatively impact their mental health, yet ACT-based aspects of the SWiM-C intervention appeared to support participants to adaptively manage the decline in their mental health. The findings can be used to inform the development of future weight management interventions, such as through intervention personalization and the inclusion of more strategies that target emotional regulation.Trial registration: ISRCTN 12107048, https://www.isrctn.com/ISRCTN12107048.

Supporting Weight Management during COVID-19: A Randomized Controlled Trial of a Web-Based, ACT-Based, Guided Self-Help Intervention.

INTRODUCTION: Adults with overweight and obesity are vulnerable to weight gain and mental health deterioration during the COVID-19 pandemic. We developed a web-based, guided self-help intervention based on Acceptance and Commitment Therapy (ACT) that aims to support adults with overweight and obesity to prevent weight gain by helping them to manage their eating behaviours, be more physically active, and protect their emotional wellbeing ("SWiM-C"). SWiM-C is a guided self-help programme using non-specialist guides to enhance scalability and population reach while minimizing cost. This study evaluated the effect of SWiM-C on bodyweight, eating behaviour, physical activity, and mental wellbeing in adults with overweight and obesity over 4 months during the COVID-19 pandemic in the UK. METHODS: We randomized adults (BMI ≥25 kg/m2) to SWiM-C or to a wait-list standard advice group. Participants completed outcome assessments online at baseline and 4 months. The primary outcome was self-measured weight; secondary outcomes were eating behaviour, physical activity, experiential avoidance/psychological flexibility, depression, anxiety, stress, and wellbeing. We estimated differences between study groups in change in outcomes from baseline to 4 months using linear regression, adjusted for outcome at baseline and the randomization stratifiers (BMI, sex). The trial was pre-registered (ISRCTN12107048). RESULTS: 486 participants were assessed for eligibility; 388 participants were randomized (196 standard advice, 192 SWiM-C), and 324 were analysed. The adjusted difference in weight between SWiM-C and standard advice was -0.60 kg (-1.67 to 0.47, p = 0.27). SWiM-C led to improvements in uncontrolled eating (-3.61 [-5.94 to -1.28]), cognitive restraint (5.28 [2.81-7.75]), experiential avoidance (-3.39 [-5.55 to -1.23]), and wellbeing (0.13 [0.07-0.18]). CONCLUSIONS: SWiM-C improved several psychological determinants of successful weight management and had a protective effect on wellbeing during the pandemic. However, differences in weight and some other outcomes were compatible with no effect of the intervention, suggesting further refinement of the intervention is needed.

A group resilience training program for people with multiple sclerosis: Study protocol of a multi-centre cluster-randomized controlled trial (multi-READY for MS).

INTRODUCTION: REsilience and Activities for every DaY (READY) is an Acceptance and Commitment Therapy-based group resilience-training program that has preliminary empirical support in promoting quality of life and other psychosocial outcomes in people with multiple sclerosis (PwMS). Consistent with the Medical Research Council framework for developing and evaluating complex interventions, we conducted a pilot randomized controlled trial (RCT), followed by a phase III RCT. The present paper describes the phase III RCT protocol. METHODS AND ANALYSIS: This is a multi-centre cluster RCT comparing READY with a group relaxation program (1:1 ratio) in 240 PwMS from eight centres in Italy (trial registration: isrctn.org Identifier: ISRCTN67194859). Both interventions are composed of 7 weekly sessions plus a booster session five weeks later. Resilience (primary outcome), mood, health-related quality of life, well-being and psychological flexibility will be assessed at baseline, after the booster session, and at three and six month follow-ups. If face-to-face group meetings are interrupted because of COVID-19 related-issues, participants will be invited to complete their intervention via teleconferencing. Relevant COVID-19 information will be collected and the COVID-19 Peritraumatic Distress scale will be administered (ancillary study) at baseline and 3-month follow-up. Analysis will be by intention-to-treat to show superiority of READY over relaxation. Longitudinal changes will be compared between the two arms using repeated-measures, hierarchical generalized linear mixed models. CONCLUSION: It is expected that his study will contribute to the body of evidence on the efficacy and effectiveness of READY by comparing it with an active group intervention in frontline MS rehabilitation and clinical settings. Results will be disseminated in peer-reviewed journals and at other relevant conferences.

Acceptance commitment therapy (ACT) for psychological distress associated with inflammatory bowel disease (IBD): protocol for a feasibility trial of the ACTforIBD programme.

INTRODUCTION: Inflammatory bowel disease (IBD) involves an abnormal immune response to healthy gut bacteria. When a person develops IBD, their susceptibility to anxiety and/or depression increases. The ACTforIBD programme, specifically designed for people with IBD and comorbid psychological distress, draws on acceptance and commitment therapy (ACT), which promotes acceptance of situations that cannot be solved such as persistent physical symptoms. There are no ACT trials for IBD using an active control group or a telemedicine approach, which is important to improve accessibility, particularly in the context of the ongoing COVID-19 pandemic. The ACTforIBD programme is administered online with a 4-hour therapist involvement per participant only; if successful it can be widely implemented to improve the well-being of many individuals with IBD. METHODS AND ANALYSIS: Our team have codesigned with consumers the ACTforIBD programme, an 8-week intervention of 1-hour sessions, with the first three sessions and the last session delivered one-to-one by a psychologist, and the other sessions self-directed online. This study aims to evaluate the feasibility and preliminary efficacy of ACTforIBD to reduce psychological distress in patients with IBD. Using a randomised controlled trial, 25 participants will be randomised to ACTforIBD, and 25 patients to an active control condition. ETHICS AND DISSEMINATION: This protocol has been approved by Deakin University Research Ethics Committee in September 2021 (Ref. 2021-263) and the New Zealand Central Health and Disability Ethics Committee in December 2021 (Ref. 2021 EXP 11384). The results of this research will be published in peer-reviewed journals and shared with various stakeholders, including community members, policy-makers and researchers, through local and international conferences. TRIAL REGISTRATION NUMBER: ACTRN12621001316897.

Supporting Weight Management during COVID-19: A Randomized Controlled Trial of a Web-Based, ACT-Based, Guided Self-Help Intervention.

INTRODUCTION: Adults with overweight and obesity are vulnerable to weight gain and mental health deterioration during the COVID-19 pandemic. We developed a web-based, guided self-help intervention based on Acceptance and Commitment Therapy (ACT) that aims to support adults with overweight and obesity to prevent weight gain by helping them to manage their eating behaviours, be more physically active, and protect their emotional wellbeing ("SWiM-C"). SWiM-C is a guided self-help programme using non-specialist guides to enhance scalability and population reach while minimizing cost. This study evaluated the effect of SWiM-C on bodyweight, eating behaviour, physical activity, and mental wellbeing in adults with overweight and obesity over 4 months during the COVID-19 pandemic in the UK. METHODS: We randomized adults (BMI ≥25 kg/m2) to SWiM-C or to a wait-list standard advice group. Participants completed outcome assessments online at baseline and 4 months. The primary outcome was self-measured weight; secondary outcomes were eating behaviour, physical activity, experiential avoidance/psychological flexibility, depression, anxiety, stress, and wellbeing. We estimated differences between study groups in change in outcomes from baseline to 4 months using linear regression, adjusted for outcome at baseline and the randomization stratifiers (BMI, sex). The trial was pre-registered (ISRCTN12107048). RESULTS: 486 participants were assessed for eligibility; 388 participants were randomized (196 standard advice, 192 SWiM-C), and 324 were analysed. The adjusted difference in weight between SWiM-C and standard advice was -0.60 kg (-1.67 to 0.47, p = 0.27). SWiM-C led to improvements in uncontrolled eating (-3.61 [-5.94 to -1.28]), cognitive restraint (5.28 [2.81-7.75]), experiential avoidance (-3.39 [-5.55 to -1.23]), and wellbeing (0.13 [0.07-0.18]). CONCLUSIONS: SWiM-C improved several psychological determinants of successful weight management and had a protective effect on wellbeing during the pandemic. However, differences in weight and some other outcomes were compatible with no effect of the intervention, suggesting further refinement of the intervention is needed.

A Psycholgical Intervention Delivered by Automated Mobile Phone Messaging Stabilized Hip and Knee Function During the COVID-19 Pandemic: A Randomized Controlled Trial.

BACKGROUND: We conducted a randomized controlled trial to evaluate the effectiveness of acceptance and commitment therapy (ACT) delivered via a mobile phone messaging robot to patients who had their total hip arthroplasty or total knee arthroplasty procedures postponed due to the COVID-19 pandemic. METHODS: Ninety patients scheduled for total hip arthroplasty or total knee arthroplasty who experienced surgical delay due to the COVID-19 pandemic were randomized to the ACT group, receiving 14 days of twice daily automated mobile phone messages, or the control group, who received no messages. Minimal clinically important differences (MCIDs) in preintervention and postintervention patient-reported outcome measures were utilized to evaluate the intervention. RESULTS: Thirty-eight percent of ACT group participants improved and achieved MCID on the Patient-Reported Outcome Measure Information System Physical Health compared to 17.5% in the control group (P = .038; number needed to treat [NNT] 5). For the joint-specific Hip Disability and Osteoarthritis Outcome Score Joint Replacement and Knee Disability and Osteoarthritis Outcome Score Joint Replacement (KOOS JR), 24% of the ACT group achieved MCID compared to 2.5% in the control group (P = .004; NNT 5). An improvement in the KOOS JR was found in 29% of the ACT group compared to 4.2% in the control group (P = .028; NNT 5). Fourteen percent of the ACT group participants experienced a clinical important decline in the KOOS JR compared to 41.7% in the control group (P = .027; NNT 4). CONCLUSION: A psychological intervention delivered via a text messaging robot improved physical function and prevented decline in patient-reported outcome measures in patients who experienced an unexpected surgical delay during the COVID-19 pandemic. LEVEL OF EVIDENCE: 1.

Group teletherapy for first-episode psychosis: Piloting its integration with coordinated specialty care during the COVID-19 pandemic.

Digital health has emerged in recent years as a tool to optimize care delivery and promote treatment adherence among individuals with first-episode psychosis (FEP). Recent mandates for social distancing and sheltering in place due to the COVID-19 pandemic have catapulted efforts to provide ongoing coordinated specialty care (CSC) on virtual platforms. While prior evidence provides support for the general implementation of virtual individual therapy, there is limited guidance and evidence for the adoption of group teletherapy. Here we describe our efforts to implement group teletherapy for two small cohorts of individuals with FEP receiving care in a coordinated specialty care clinic using methods adopted from Acceptance and Commitment Therapy. We observed high adherence with group visits as well as client satisfaction across groups. Based on our results, we have taken efforts to implement virtual group therapy more permanently in our clinic. Our experience provides guidance and a model for integration of virtual group therapy within CSC. PRACTITIONER POINTS: In-person group therapy can be adapted as an online treatment modality for individuals with first-episode psychosis (FEP). Group teletherapy is both accessible and satisfactory to individuals with FEP. Group teletherapy has potential as a more standard and widespread treatment modality within coordinated specialty care for FEP.