A randomized clinical trial: Efficacy of group-based acceptance and commitment therapy program for breast cancer patients with high fear of progression.

BACKGROUND: Fear of progression (FOP) is a common and significant concern among cancer patients, encompassing worries about cancer progression during active treatment. Elevated levels of FOP can be dysfunctional. This study aims to assess the efficacy of an Acceptance and Commitment Therapy (ACT)-based intervention on FOP, anxiety sensitivity (AS), and quality of life (QOL) in breast cancer patients. METHODS: A clinical trial was conducted involving 80 stage I-III active-treatment breast cancer patients with a score greater than 34 on the Fear of Progression Questionnaire-Short Form scale. These patients were randomly assigned in a 1:1 ratio to either an intervention group, which received weekly 70-min sessions of 5-ACT-bsed group-therapy, or a control group that received usual treatment. Variables including FOP, AS, QOL, and ACT-related factors were assessed using ASQ, QLQ-C30, Cognitive Fusion Questionnaire, and Acceptance and Action Questionnaire-II at three time points: baseline, post-intervention, and 3-month follow-up. The efficacy of the intervention was evaluated using mixed model analysis across all time-points. RESULTS: The fidelity and acceptability of the ACT-based manual were confirmed using significant methods. A significant reduction in FOP was observed only in the ACT group at post-intervention (P-valueACT < 0.001; Cohen dACT = 1.099). Furthermore, the ACT group demonstrated a more significant reduction in FOP at follow-up. Furthermore, all secondary and ACT-related variables, except for the physical symptoms subscale, showed significant improvement in the ACT group compared to the control group. CONCLUSIONS: Our ACT-based manual showed promise for reducing FOP, AS, and improving QOL, and ACT-related variables in breast cancer patients 3 months following the intervention.

Acceptance and Commitment Therapy for improving the performance of chess players suffering from anxiety disorders

Previous research has suggested that brief protocols based on acceptance and commitment therapy (ACT) are efficacious in improving elite chess players' performance without clinical problems. These promising results warranted the examination of the effect of longer ACT interventions with chess players suffering from emotional difficulties. This study advances in this direction by presenting two case studies of elite chess players experiencing anxiety disorders. Each participant was matched to a control participant with similar characteristics. The ACT interventions were conducted in 5 sessions and with occasional follow-ups during the following year. The primary dependent variable was an objective measure of chess performance (ELO Performance). Data analysis was conducted using the JZS+AR Bayesian hypothesis testing for single-case designs and the nonparametric Tau-U statistic. Control participants did not significantly improve their chess performance during the follow-up, but chess players who received the intervention showed significant increases in their performance. Both treated participants experienced clinically significant reductions in symptomatology and improved valued living after the intervention. This study provides empirical evidence regarding the potential benefit of applying ACT to improve chess performance in players with clinical problems (AU)

Feasibility of RESTORE: An online Acceptance and Commitment Therapy intervention to improve palliative care staff wellbeing.

BACKGROUND: Acceptance and Commitment Therapy is a form of Cognitive Behavioural Therapy which uses behavioural psychology, values, acceptance and mindfulness techniques to improve mental health and wellbeing. Acceptance and Commitment Therapy is efficacious in treating stress, anxiety and depression in a broad range of settings including occupational contexts where emotional labour is high. This approach could help palliative care staff to manage work-related stress and promote wellbeing. AIM: To develop, and feasibility test, an online Acceptance and Commitment Therapy intervention to improve wellbeing of palliative care staff. DESIGN: A single-arm feasibility trial of an 8-week Acceptance and Commitment Therapy based intervention for staff, consisting of three online facilitated group workshops and five online individual self-directed learning modules. Data was collected via online questionnaire at four time-points and online focus groups at follow-up. SETTING/PARTICIPANTS: Participants were recruited from Marie Curie hospice and nursing services in Scotland. RESULTS: Twenty five staff commenced and 23 completed the intervention (93%). Fifteen participated in focus groups. Twelve (48%) completed questionnaires at follow-up. Participants found the intervention enjoyable, informative and beneficial. There was preliminary evidence for improvements in psychological flexibility (Cohen's d = 0.7) and mental wellbeing (Cohen's d = 0.49) between baseline and follow-up, but minimal change in perceived stress, burnout or compassion satisfaction. CONCLUSION: Online Acceptance and Commitment Therapy for wellbeing is acceptable to palliative care staff and feasible to implement using Microsoft Teams in a palliative care setting. Incorporating ways to promote long-term maintenance of behaviour changes, and strategies to optimise data collection at follow-up are key considerations for future intervention refinement and evaluation.

Evaluating an interactive acceptance and commitment therapy (ACT) workshop delivered to trained therapists working with cancer patients in the United Kingdom: a mixed methods approach.

BACKGROUND: SURECAN (SUrvivors' Rehabilitation Evaluation after CANcer) is a multi-phase study developing and evaluating an Acceptance and Commitment Therapy (ACT) intervention integrated with exercise and work when highly valued (thus we called the intervention ACT+), for people who have completed treatment for cancer but who have low quality of life. We developed a training programme for therapists working in different psychological services to be delivered over 2-3 days. Our aim was to evaluate the extent to which the training could improve therapists' knowledge and confidence to deliver ACT+ to cancer patients in a trial setting. METHODS: Three interactive workshops were delivered to 29 therapists from three clinical settings in London and in Sheffield. A mixed-methods approach was used. Questionnaires were designed to assess knowledge and confidence in using ACT+ with people who have low quality of life after cancer treatment. They were self-administered immediately prior to and after each workshop. Open text-based questions were used to elicit feedback about the workshops alongside a satisfaction scale. Semi-structured interviews were conducted with a purposive sample of therapists (n = 12) to explore their views about the training more deeply, and how it might be optimised. RESULTS: Quantitative analysis showed that knowledge of ACT, as well as confidence in using the ACT+ intervention in this setting increased significantly after training (28.6 and 33.5% increase in the median score respectively). Qualitative analysis indicated that most therapists were satisfied with the content and structure of the programme, valued the rich resources provided and enjoyed the practice-based approach. Potential barriers/facilitators to participation in the trial and to the successful implementation of ACT+ were identified. For some therapists, delivering a manualised intervention, as well as supporting exercise- and work-related goals as non-specialists was seen as challenging. At the same time, therapists valued the opportunity to be involved in research, whilst training in a new therapy model. CONCLUSIONS: Training can effectively improve the knowledge and confidence of therapists from different clinical backgrounds to deliver a modified ACT intervention to cancer patients in a trial setting.

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.

BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: Netherlands Trial Register: TRIAL NL6131 (NTR6270); https://www.trialregister.nl/trial/6131.

A systematic review and meta-analysis of acceptance- and mindfulness-based interventions for DSM-5 anxiety disorders.

This meta-analysis systematically reviewed the evidence on standardized acceptance-/mindfulness-based interventions in DSM-5 anxiety disorders. Randomized controlled trials examining Acceptance and Commitment Therapy (ACT), Mindfulness-Based Cognitive Therapy (MBCT), and Mindfulness-Based Stress Reduction (MBSR) were searched via PubMed, Central, PsycInfo, and Scopus until June 2021. Standardized mean differences (SMD) and 95% confidence intervals (CI) were calculated for primary outcomes (anxiety) and secondary ones (depression and quality of life). Risk of bias was assessed using the Cochrane tool. We found 23 studies, mostly of unclear risk of bias, including 1815 adults with different DSM-5 anxiety disorders. ACT, MBCT and MBSR led to short-term effects on clinician- and patient-rated anxiety in addition to treatment as usual (TAU) versus TAU alone. In comparison to Cognitive Behavioral Therapy (CBT), ACT and MBCT showed comparable effects on both anxiety outcomes, while MBSR showed significantly lower effects. Analyses up to 6 and 12 months did not reveal significant differences compared to TAU or CBT. Effects on depression and quality of life showed similar trends. Statistical heterogeneity was moderate to considerable. Adverse events were reported insufficiently. The evidence suggests short-term anxiolytic effects of acceptance- and mindfulness-based interventions. Specific treatment effects exceeding those of placebo mechanisms remain unclear. Protocol registry: Registered at Prospero on November 3rd, 2017 (CRD42017076810).

Cognitive defusion as a verbal exercise: an experimental approach / Defusión Cognitiva como Ejercicio Verbal: un Enfoque Experimental

BACKGROUND: As one of the founding principles of Acceptance and Commitment Therapy (ACT), cognitive defusion is a contextual control of language, but it is not clear which behavioural process would allow such defusion. Two experiments are presented which analyse that process using a word repetition exercise. METHOD: Experiment 1 was performed with 30 randomised participants, using a factorial between-groups (4×2) with repeated measures design: Group 1 = milk-milk-milk exercise; 2 = emotional word repetition; 3 = milk-to-emotional word shaping; and 4 = control without intervention. Questionnaires were applied on thoughts, emotional regulation, and experiential avoidance, in addition to the evaluation of 20 images suggesting emotions. In Experiment 2, 78 participants were randomised using the same 4×2 design, and also 60 images with a proven emotional reactivity were used. RESULTS: Experiment 1 did not show changes in any of the variables, nor a decrease in emotional assessment, which should occur according to the theory behind ACT. In Experiment 2, no significant changes between the groups and no pre-post changes appeared, except in latency time. CONCLUSIONS: The lack of replication of the defusion process is discussed, along with the mixed results of other studies

ANTECEDENTES: desde la Terapia de Aceptación y Compromiso (ACT), la defusión cognitiva es un proceso de control contextual del lenguaje, aunque no está claro cuál sería el proceso conductual de esa defusión. Se presentan dos experimentos analizando ese proceso mediante un ejercicio de repetición de palabras. MÉTODO: el primer experimento se realizó con 30 participantes aleatorizados, con un diseño factorial entre-grupos con medidas repetidas (4×2): Grupo 1 = ejercicio leche-leche; 2 = repetición de palabra emocional; 3 = moldeamiento leche-palabra emocional; y 4 = control. Se han utilizado cuestionarios sobre pensamientos, regulación emocional y evitación experiencial, junto con la valoración de 20 imágenes que sugerían emociones. En el segundo experimento se aleatorizaron 78 participantes con el mismo diseño 4×2, y se utilizaron 60 imágenes con una reactividad emocional ya comprobada. RESULTADOS: en el primer experimento no hubo cambios en ninguna de las variables, ni la disminución de la valoración emocional que debería producirse según la teoría de ACT. Tampoco en el segundo experimento aparecieron cambios significativos entre los grupos, ni pre-post, excepto en el tiempo de latencia. CONCLUSIONES: se discute la falta de replicación del proceso de defusión que defiende ACT, siguiendo también los resultados dispares de otros estudios

Two randomized controlled trials of the efficacy of acceptance and commitment therapy-based educational course for body shape dissatisfaction.

The main aim of this project was to explore the efficacy of Acceptance and Commitment Therapy (ACT)-based educational course in different formats (i.e., pure and guided self-help with different durations, and guided self-help with and without access to a discussion forum) for body shape dissatisfaction. Two randomized controlled studies (RCT) were carried out. In the first RCT, the participants were randomized to a 12- or 16-week guided self-help, a 16-week pure self-help, or a waitlist control condition. In the second RCT, the efficacy of 12-week guided self-help with or without access to a discussion forum was investigated. ACT-based self-help resulted in promising improvements in body shape dissatisfaction, and modest effects on general health indicators (i.e., symptom of depression, self-esteem, satisfaction with life, and quality of life). The findings also showed no additional effects of support, access to the online discussion forum, and longer duration of self-help, suggesting the 12-week self-help with or without support is a viable option for reducing body shape dissatisfaction.

Efficacy of internet-delivered acceptance and commitment therapy for severe health anxiety: results from a randomized, controlled trial.

BACKGROUND: Health anxiety is common, disabling and costly due to patients' extensive use of health care services. Internet-delivered treatment may overcome barriers of accessibility to specialized treatment. We aimed to evaluate the efficacy of internet-delivered acceptance and commitment therapy (iACT). METHODS: A randomized, controlled trial of iACT versus an internet-delivered discussion forum (iFORUM), performed in a Danish university hospital setting. Patients self-referred and underwent video-diagnostic assessment. Eligible patients (≥18 years) with health anxiety were randomized to 12 weeks of intervention. The randomization was blinded for the assessor. The primary outcome was between-group unadjusted mean differences in health anxiety symptoms measured by the Whiteley-7 Index (WI-7, range 0-100) from baseline to 6-month follow-up (6-MFU) using intention to treat and a linear mixed model. The study is registered at clinicaltrials.gov, number NCT02735434. RESULTS: A total of 151 patients self-referred, and 101 patients were randomized to iACT (n = 53) or iFORUM (n = 48). A mean difference in change over time of 19.0 points [95% confidence interval (CI) 10.8-27.2, p < 0.001] was shown on the WI-7, and a large standardized effect size of d = 0.80 (95% CI 0.38-1.23) at 6-MFU. The number needed to treat was 2.8 (95% CI 1.8-6.1, p < 0.001), and twice as many patients in iACT were no longer clinical cases (35% v. 16%; risk ratio 2.17, 95% CI 1.00-4.70, p = 0.050). Adverse events were few and insignificant. CONCLUSIONS: iACT for health anxiety led to sustained effects at 6-MFU. The study contributes to the development of easily accessible treatment options and deserves wider application.

The effects of acceptance and commitment therapy on the psychological and physical outcomes among cancer patients: A meta-analysis with trial sequential analysis.

OBJECTIVE: The current study used meta-analysis and trial sequential analysis to estimate the effects of Acceptance and Commitment Therapy (ACT) on the psychological and physical distress of cancer patients, and to identify potential moderators in this body of research. METHODS: A search of multiple databases in February 2020 identified 25 independent trials (17 randomized controlled trials, 8 non-randomized controlled trials; 2256 participants) on the effects of ACT among cancer patients. Trial sequential analysis (TSA) was used to determine whether the available evidence is sufficient to draw strong conclusions. RESULTS: ACT significantly reduced cancer patients' psychological distress (g = 0.88), and improved psychological flexibility (g = 0.58), quality of life (g = 1.19), and sense of hope (g = 2.17). TSA showed that there was sufficient evidence to obtain stable estimates of the effect of ACT on psychological distress and quality of life. Effect sizes for psychological distress were larger in studies conducted in eastern countries, in younger samples, and when therapy was of longer duration. CONCLUSION: Acceptance and Commitment Therapy can effectively improve the mental health of cancer patients, and can be applied to clinical practice as an effective psychological intervention. Researchers are encouraged to take into account stage and trajectory of cancer in future studies.

Symptom experiences in post-treatment cancer survivors: associations with acceptance and commitment therapy constructs.

PURPOSE: Acceptance and Commitment Therapy (ACT) has improved symptom and quality-of-life outcomes in pilot research with post-treatment cancer survivors. To further test the ACT model, the present study examined relationships between ACT constructs and subgroups of post-treatment survivors based on the severity of common symptoms. METHODS: Survivors who had completed primary treatment for stage I or II cancer (N = 203) participated in this one-time survey. Latent class analysis (LCA) was used to identify subgroups of survivors based on the severity of fatigue, sleep disturbance, pain, anxiety, and depressive symptoms. Multinomial logistic regressions employing Vermunt's 3-step approach were used to examine ACT constructs (e.g., mindfulness, acceptance, values progress) as correlates of survivor subgroups based on symptoms. RESULTS: The LCA showed three survivor classes: (1) mild-to-moderate levels of all symptoms except for normal pain intensity; (2) mild anxiety, moderate fatigue, and normal levels of all other symptoms; and (3) normal levels of all symptoms. Lower mindfulness, acceptance, and values progress and higher cognitive fusion, psychological inflexibility, and values obstruction were associated with a greater likelihood of being in class 1 or 2 than in class 3. CONCLUSION: Findings are consistent with the ACT model. Survivors with greater symptom burden reported greater withdrawal from personally meaningful activities and less acceptance of their cancer diagnosis and internal experiences (e.g., thoughts, feelings, symptoms). Findings provide strong justification for further testing of ACT to reduce symptom-related suffering in cancer survivors.

Effectiveness of a guided ACT-based self-help resilience training for depressive symptoms during pregnancy: Study protocol of a randomized controlled trial embedded in a prospective cohort.

BACKGROUND: During pregnancy, about 10 to 20% of women experience depressive symptoms. Subclinical depression increases the risk of peripartum depression, maternal neuro-endocrine dysregulations, and adverse birth and infant outcomes. Current treatments often comprise face-to-face psychological or pharmacological treatments that may be too intensive for women with subclinical depression leading to drop-out and moderate effectiveness. Therefore, easily accessible, resilience enhancing and less stigmatizing interventions are needed to prevent the development of clinical depression. This paper describes the protocol of a prospective cohort study with an embedded randomized controlled trial (RCT) that aims to improve mental resilience in a sample of pregnant women through a self-help program based on the principles of Acceptance and Commitment Therapy (ACT). Maternal and offspring correlates of the trajectories of peripartum depressive symptoms will also be studied. METHODS: Pregnant women (≥ 18 years) receiving care in Dutch midwifery practices will participate in a prospective cohort study (n ~ 3500). Between 12 and 18 weeks of pregnancy, all women will be screened for depression with the Edinburgh Postnatal Depression Scale (EPDS). Women with an EPDS score ≥ 11 will be evaluated with a structured clinical interview. Participants with subclinical depression (n = 290) will be randomized to a 9-week guided self-help ACT-training or to care as usual (CAU). Primary outcomes (depressive symptoms and resilience) and secondary outcomes (e.g. anxiety and PTSD, bonding, infant development) will be collected via online questionnaires at four prospective assessments around 20 weeks and 30 weeks gestation and at 6 weeks and 4 months postpartum. Maternal hair cortisol concentrations will be assessed in a subsample of women with a range of depressive symptoms (n = 300). The intervention's feasibility will be assessed through qualitative interviews in a subsample of participants (n = 20). DISCUSSION: This is the first study to assess the effectiveness of an easy to administer intervention strategy to prevent adverse mental health effects through enhancing resilience in pregnant women with antepartum depressive symptomatology. This longitudinal study will provide insights into trajectories of peripartum depressive symptoms in relation to resilience, maternal cortisol, psychological outcomes, and infant developmental milestones. TRIAL REGISTRATION: Netherlands Trial Register (NTR), NL7499 . Registered 5 February 2019.

Brief Acceptance and Commitment Therapy for Fibromyalgia: Feasibility and Effectiveness of a Replicated Single-Case Design.

Objective: Overall, the literature on the effectiveness of psychological treatments in general and those for fibromyalgia in particular has been dominated by research designs that focus on large groups and explore changes on average, so the treatment impact at the individual level remains unclear. In this quasi-experimental, replicated single-case design, we will test the feasibility and effectiveness of a brief acceptance and committed therapy intervention using ecological momentary assessment supported by technology. Methods: The sample comprised 7 patients (3 in the individual condition and 4 in the group condition) who received a brief, 5-week psychological treatment. Patient evolution was assessed one week prior to treatment onset and during the whole study with a smartphone app. Because ecological momentary assessment and the use of an app are not frequent practices in routine care, we also evaluated the feasibility of this assessment methodology (i.e., compliance with the app). Change was investigated with a nonoverlap of all pairs index. Outcomes were pain interference with sleep and social activities, fatigue, sadness, and pain intensity. Results: Patient change was not uniform across outcomes. Four patients (two in each condition) showed relatively moderate levels of change (approximately 60% nonoverlap in several outcomes). The remaining patients showed more modest improvements which affected a reduced number of outcomes. Based on nonoverlapping indices, there was no clear evidence in favor of any treatment format. Conclusions: An alternative design to large-scale trials, one that focuses on the individual change, exists and it can be implemented in pain research. The use of technology (e.g., smartphones) simplifies such designs by facilitating ecological momentary assessment. Based on our findings showing that changes were not homogeneous across patients or outcomes, more single-case designs and patient-centered analyses (e.g., responder and moderation analyses) are required.

Preliminary evidence of the effectiveness of acceptance and commitment therapy for death anxiety in Iranian clients diagnosed with obsessive-compulsive disorder.

The authors investigated the effectiveness of acceptance and commitment therapy (ACT) for the treatment of death anxiety and obsessive-compulsive disorder (OCD) with eight adult women in Iran. The ACT protocol was conducted in weekly solo sessions with each participant for 8 weeks (45 minutes each). The results were analyzed by visual analysis method and improvement percentage. ACT resulted in a 60%-80% decrease in death anxiety and a 51%-60% decrease in obsessive-compulsive symptoms, thereby indicating promise for ACT as a treatment for OCD and death anxiety.

Using acceptance and commitment therapy techniques to enhance treatment engagement in veterans with posttraumatic stress disorder.

Evidence-based treatments for posttraumatic stress disorder (PTSD) are available for veterans, but many do not benefit due to low treatment engagement. This may be partially due to avoidance behaviors characteristic of individuals with PTSD. Acceptance and Commitment Therapy (ACT) is a transdiagnostic treatment approach that aims to reduce avoidance. The authors propose the use of adjunctive ACT techniques to enhance engagement with treatment for PTSD. ACT techniques such as cognitive defusion and values clarification have been shown to promote engagement with other cognitive-behavioral treatments, but no studies to date have examined these techniques as adjuncts to treatment for PTSD. Because of its focus on reducing avoidance, ACT is uniquely suited for promoting treatment engagement with the "gold standard" treatments for PTSD. The authors review the existing research on ACT as an adjunctive intervention, discuss specific concepts and techniques from ACT that are relevant to PTSD, and provide recommendations for future research.

A systematic review of values interventions in acceptance and commitment therapy

Acceptance and Commitment Therapy (ACT) is characterized by a focus on contextual change and advances topics like acceptance, mindfulness, values, spirituality and relationship. It sets itself apart from other third wave approaches by bringing to the center of the therapeutic work values clarification and living. Previous systematic reviews provided support for the efficacy and effectiveness of Acceptance and Commitment Therapy (ACT) but it's unknown of reviews that comprehensively assess values interventions with a focus on examining the specific effects of working with values or meaning in life in a wide variety of settings, populations and methodological designs. The goal of this study is to investigate empirical interventions that utilizes values as conceptualized by ACT. Systematic searches in 5 databases were performed up to April 2020. For inclusion, the intervention study must have targeted values process as conceptualized by ACT. Systematic reviews, theoretical or conceptual papers were excluded. Analyzed data were publication year, language, country, number and description of participants, mean age, sample origin, outcome variables, study design and quality and overall results. Seventeen studies were identified. Results show a broad scope of research methods, in a variety of settings and populations. According to reported results, values interventions had the desired effect on the outcome variable

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One-day Acceptance and Commitment Therapy workshop for preventing persistent post-surgical pain and dysfunction in at-risk veterans: A randomized controlled trial protocol.

OBJECTIVE: Persistent post-surgical pain is common among patients undergoing surgery, is detrimental to patients' quality of life, and can precipitate long-term opioid use. The purpose of this randomized controlled trial is to assess the effects of a behavioral intervention offered prior to surgery for patients at risk for poor post-surgical outcomes, including persistent pain and impaired functioning. METHODS: Described herein is an ongoing randomized, patient- and assessor-blind, attention-controlled multisite clinical trial. Four hundred and thirty Veterans indicated for total knee arthroplasty (TKA) with distress and/or pain will be recruited for this study. Participants will be randomly assigned to a one-day (~5 h) Acceptance and Commitment Therapy workshop or one-day education and attention control workshop. Approximately two weeks following their TKA surgery, patients receive an individualized booster session via phone. Following their TKA, patients complete assessments at 1 week, 6 weeks, 3 months, and 6 months. RESULTS: The primary outcomes are pain intensity and knee-specific functioning; secondary outcomes are symptoms of distress and coping skills. Mediation analyses will examine whether changes in symptoms of distress and coping skills have an impact on pain and functioning at 6 months in Veterans receiving ACT. This study is conducted mostly with older Veterans; therefore, results may not generalize to women and younger adults who are underrepresented in this veteran population. CONCLUSIONS: The results of this study will provide the first evidence from a large-scale, patient- and assessor-blind controlled trial on the effectiveness of a brief behavioral intervention for the prevention of persistent post-surgical pain and dysfunction.

Effect of a Videoconference-Based Online Group Intervention for Traumatic Stress in Parents of Children With Life-threatening Illness: A Randomized Clinical Trial.

Importance: A substantial proportion of parents whose child is diagnosed with a life-threatening illness experience high levels of distress that can lead to long-term mental health difficulties. This can affect the child's recovery. Objective: To evaluate the efficacy of an acceptance and commitment therapy-based group intervention, delivered using videoconferencing, in reducing posttraumatic stress symptoms (PTSS) in these parents. Design, Setting, and Participants: This study was a randomized clinical trial of an intervention for parents with elevated acute stress symptoms. It was a single-site study conducted in a tertiary pediatric hospital in Australia. Parents of children aged 0 to 18 years admitted for a life-threatening illness or injury to the oncology, cardiology, or pediatric intensive care departments were eligible. Participants were screened for eligibility within the first month after diagnosis or admission and then were randomized to the intervention group or the waiting list control group 4 to 10 months after diagnosis or admission. Recruitment commenced January 2014, and final postintervention follow-up was completed in February 2018. Data analysis was performed from July to September 2018. Interventions: Treatment was a psychological acceptance and commitment therapy-based group therapy program called Take a Breath, which consisted of a 6-session parent-mediated psychological intervention delivered via online videoconferences over the course of 8 weeks. Waiting list control participants received treatment as usual and were offered the intervention 3 months after randomization. Main Outcomes and Measures: The primary outcome was PTSS, as measured by the Posttraumatic Stress Disorder Checklist-Version 5 (total score range, 0-80, with higher scores indicating greater symptom severity). The PTSS was measured both before and immediately after the intervention. Changes in psychological skills taught within the intervention were also evaluated, including acceptance, mindfulness, values-based living, and psychological flexibility. Results: Of 1232 parents who were assessed for eligibility, 313 were randomized; 161 were allocated to the waiting list control group, and 152 were allocated to the intervention group. Of those allocated, 44 parents in the waiting list group and 37 in the intervention group completed the postintervention questionnaire and were analyzed (81 participants total; mean [SD] age, 37.17 [6.43] years). Sixty-five participants (80.2%) were women, 48 participants (59.3%) were married, and 40 participants (49.4%) lived in rural or regional areas, or in a different state. In addition, 24 parents (29.6%) were in the cardiology illness group, 32 parents (39.5%) were in the oncology group, and 25 parents (30.9%) were in the pediatric intensive care unit group. The intervention group demonstrated significantly greater improvements in PTSS compared with the waiting list group (Cohen d = 1.10; 95% CI, 0.61-1.59; P = .03). The mean Posttraumatic Stress Disorder Checklist-Version 5 scores decreased from 31.7 (95% CI, 27.0-36.4) to 26.2 (95% CI, 21.8-30.7) in the waiting list control group and from 23.3 (95% CI, 18.6-28.1) to 17.8 (95% CI, 13.8-21.8) in the intervention group. Conclusions and Relevance: The findings of this study support the use of acceptance and commitment therapy to reduce PTSS in parents of very ill children, regardless of diagnosis. These findings also suggest that a brief, group format using a videoconferencing platform can be used effectively to access hard-to-reach populations, particularly fathers and caregivers living in nonmetropolitan areas. Trial Registration: Australian New Zealand Clinical Trials Registry Identifier: ACTRN12611000090910.

Acceptance and Commitment Therapy for perinatal mood and anxiety disorders: A feasibility and proof of concept study.

OBJECTIVES: The aim of the current study was to assess the feasibility, safety, and effectiveness of a newly developed Acceptance and Commitment Therapy (ACT) intervention developed specifically to address the unique context of pregnancy and parenthood. The intervention was delivered to women accessing a specialist Perinatal Community Mental Health Service (PCMHS). DESIGN: An open-label pilot study was conducted of an 8-week, group-delivered ACT intervention targeting women with moderate-to-severe mood and/or anxiety disorders during pregnancy and/or postpartum. METHODS: Outcomes included session attendance rates, dropout rates, crisis/inpatient service use, and standardized symptom scales. Participant's responses to open-ended questions contained in an end of therapy questionnaire were analysed using thematic analysis. RESULTS: Seventy-four women were referred to the intervention with 65 (88%) completing treatment. The median number of sessions attended was 7. No women required input from crisis/inpatient services. All reported finding the intervention helpful. The implementation of ACT in daily life, therapist support, and group processes were cited as helpful aspects of the intervention. At post-treatment, there was a significant reduction in global distress (d = 0.99) and depressive symptoms (d = 1.05), and an increase in psychological flexibility (d = 0.93). On the secondary outcome of global distress, 38% of women were classified as recovered, 31% had reliably improved, 27% remained the same, and 4% had reliably deteriorated. CONCLUSIONS: The delivery of ACT in a routine practice setting is feasible, safe, and effective. A randomized control trial (RCT) is needed to establish the efficacy and cost-effectiveness of this group-delivered ACT intervention. PRACTITIONER POINTS: Group-delivered Acceptance and Commitment Therapy (ACT) is acceptable for women with moderate-to-severe perinatal mood and/or anxiety disorders and can be feasibly delivered in a routine practice setting. The trans-diagnostic nature of ACT enables the concurrent treatment of depressive and anxiety symptoms within the same intervention which is particularly helpful in the perinatal context given the comorbidity of mood and anxiety disorders. With training and supervision, mental health practitioners without extensive education in the delivery of psychological therapies can facilitate the ACT group programme. As this was a feasibility study, there was no control group, adherence to the manual was not assessed, and the absence of a follow-up period limits our knowledge of the longer-term benefits of the ACT group programme.

Acceptance and Commitment Therapy Delivered via a Mobile Phone Messaging Robot to Decrease Postoperative Opioid Use in Patients With Orthopedic Trauma: Randomized Controlled Trial.

BACKGROUND: Acceptance and commitment therapy (ACT) is a pragmatic approach to help individuals decrease avoidable pain. OBJECTIVE: This study aims to evaluate the effects of ACT delivered via an automated mobile messaging robot on postoperative opioid use and patient-reported outcomes (PROs) in patients with orthopedic trauma who underwent operative intervention for their injuries. METHODS: Adult patients presenting to a level 1 trauma center who underwent operative fixation of a traumatic upper or lower extremity fracture and who used mobile phone text messaging were eligible for the study. Patients were randomized in a 1:1 ratio to either the intervention group, who received twice-daily mobile phone messages communicating an ACT-based intervention for the first 2 weeks after surgery, or the control group, who received no messages. Baseline PROs were completed. Two weeks after the operative intervention, follow-up was performed in the form of an opioid medication pill count and postoperative administration of PROs. The mean number of opioid tablets used by patients was calculated and compared between groups. The mean PRO scores were also compared between the groups. RESULTS: A total of 82 subjects were enrolled in the study. Of the 82 participants, 76 (38 ACT and 38 controls) completed the study. No differences between groups in demographic factors were identified. The intervention group used an average of 26.1 (SD 21.4) opioid tablets, whereas the control group used 41.1 (SD 22.0) tablets, resulting in 36.5% ([41.1-26.1]/41.1) less tablets used by subjects receiving the mobile phone-based ACT intervention (P=.004). The intervention group subjects reported a lower postoperative Patient-Reported Outcome Measure Information System Pain Intensity score (mean 45.9, SD 7.2) than control group subjects (mean 49.7, SD 8.8; P=.04). CONCLUSIONS: In this study, the delivery of an ACT-based intervention via an automated mobile messaging robot in the acute postoperative period decreased opioid use in selected patients with orthopedic trauma. Participants receiving the ACT-based intervention also reported lower pain intensity after 2 weeks, although this may not represent a clinically important difference. TRIAL REGISTRATION: ClinicalTrials.gov NCT03991546; https://clinicaltrials.gov/ct2/show/NCT03991546.