Behavioral cancer pain intervention dosing: results of a Sequential Multiple Assignment Randomized Trial.

ABSTRACT: Behavioral pain management interventions are efficacious for reducing pain in patients with cancer. However, optimal dosing of behavioral pain interventions for pain reduction is unknown, and this hinders routine clinical use. A Sequential Multiple Assignment Randomized Trial (SMART) was used to evaluate whether varying doses of Pain Coping Skills Training (PCST) and response-based dose adaptation can improve pain management in women with breast cancer. Participants (N = 327) had stage I-IIIC breast cancer and a worst pain score of > 5/10. Pain severity (a priori primary outcome) was assessed before initial randomization (1:1 allocation) to PCST-Full (5 sessions) or PCST-Brief (1 session) and 5 to 8 weeks later. Responders ( > 30% pain reduction) were rerandomized to a maintenance dose or no dose and nonresponders (<30% pain reduction) to an increased or maintenance dose. Pain severity was assessed again 5 to 8 weeks later (assessment 3) and 6 months later (assessment 4). As hypothesized, PCST-Full resulted in greater mean percent pain reduction than PCST-Brief (M [SD] = -28.5% [39.6%] vs M [SD]= -14.8% [71.8%]; P = 0.041). At assessment 3 after second dosing, all intervention sequences evidenced pain reduction from assessment 1 with no differences between sequences. At assessment 4, all sequences evidenced pain reduction from assessment 1 with differences between sequences ( P = 0.027). Participants initially receiving PCST-Full had greater pain reduction at assessment 4 ( P = 0.056). Varying PCST doses led to pain reduction over time. Intervention sequences demonstrating the most durable decreases in pain reduction included PCST-Full. Pain Coping Skills Training with intervention adjustment based on response can produce sustainable pain reduction.

Role of self-efficacy for pain management and pain catastrophizing in the relationship between pain severity and depressive symptoms in women with breast cancer and pain.

PURPOSE: This study evaluated the relationship between pain and depressive symptoms through pain self-efficacy and pain catastrophizing in breast cancer patients with pain. DESIGN: Secondary analysis of a randomized trial investigating a cognitive-behavioral pain management protocol. SAMPLE: Females (N = 327) with stage I-III breast cancer and report of at least moderate pain. METHODS: Pain severity, pain self-efficacy, pain catastrophizing, and depressive symptoms were measured. The proposed model was assessed using structural equation modeling. RESULTS: Higher pain severity was significantly related to lower pain self-efficacy and higher pain catastrophizing. Lower pain self-efficacy and higher pain catastrophizing were significantly related to more depressive symptoms. Higher pain severity was significantly associated with more depressive symptoms through lower pain self-efficacy and higher pain catastrophizing. The association between pain severity and depressive symptoms was not significant when specified as a direct effect. CONCLUSION: Pain severity related to depressive symptoms in breast cancer patients via pain self-efficacy and pain catastrophizing. IMPLICATIONS FOR PSYCHOSOCIAL PROVIDERS: Measurement of pain self-efficacy and pain catastrophizing should be incorporated into comprehensive pain assessments for women with breast cancer, as these variables may be relevant therapeutic targets. Psychosocial symptom management interventions should include strategies that increase pain self-efficacy and decrease pain catastrophizing because these pain-related cognitive variables appear to drive the relationship between pain severity and depressive symptoms.

Improving well-being for individuals with persistent pain after surgery for breast cancer, lobular carcinoma in situ, or ductal carcinoma in situ: A randomized clinical trial.

>276,000 Americans will be diagnosed with invasive breast cancer, lobular carcinoma in situ, or ductal carcinoma in situ this year and most will undergo breast surgery as part of their care. Although prognosis is excellent, many patients experience persistent post-surgical pain (PSP), which has no satisfactory pharmacological treatment. The causal contributions of pain-associated psychological factors (e.g., catastrophic thoughts about pain, psychological flexibility, self-efficacy) to the continuing burden of PSP have not yet been determined and may be opportune intervention targets. The randomized trial described here will compare the benefits of three manualized behavioral interventions for individuals with PSP. Participants will receive either: 1) self-guided health education (SGHE); 2) interventionist-guided health education (IGHE); or 3) interventionist-guided pain coping skills training with elements of acceptance and commitment therapy that specially target catastrophic thoughts about pain, self-efficacy, and psychological flexibility (CST-PSP). Participants will prospectively complete validated assessments of primary outcomes (PSP severity and interference) at baseline (pre-intervention) and 3-, 6-, and 12-months later. Validated measures of emotional distress and cancer-specific distress will be assessed as secondary outcomes. To test their roles as drivers of PSP, catastrophic thoughts about pain, self-efficacy, and psychological flexibility, will be assessed and statistically analyzed as mediators of hypothesized beneficial effects. The interventions' impacts on pain sensitivity and central sensitization will be investigated to test these physiological pathways as proximal drivers of PSP. To better characterize the patient experience, additional validated measures will be explored for associations with PSP, along with demographic and clinical factors. Trial registration: https://clinicaltrials.gov/ct2/show/NCT04225585, registered January 13, 2020.

Linking physical activity to personal values: feasibility and acceptability randomized pilot of a behavioral intervention for older adults with osteoarthritis pain.

BACKGROUND: Osteoarthritis (OA) pain is common and leads to functional impairment for many older adults. Physical activity can improve OA outcomes for older adults, but few are appropriately active. Behavioral interventions can reduce physical activity barriers. We developed and tested a brief, novel behavioral intervention (i.e., Engage-PA) for older adults combining values to enhance motivation and strategic activity pacing to improve arthritis-related pain and functioning and increase physical activity. METHODS: A randomized feasibility and acceptability pilot trial compared Engage-PA to treatment-as-usual plus fitness tracker (TAU+) in N = 40 adults age 65+ with OA pain in the knee or hip. Engage-PA involved two 60-min telephone sessions. All participants wore a fitness tracker to collect daily steps throughout the study and completed baseline and post-treatment assessments of secondary outcomes (arthritis-related pain and physical functioning, physical activity, psychological distress, psychological flexibility, and valued living). The impact of COVID-19 on general well-being and physical activity was also assessed. Descriptive statistics were conducted for feasibility and acceptability outcomes. Indicators of improvement in secondary outcomes were examined via change scores from baseline to post-treatment and performing independent samples t-tests to assess for between-group differences. RESULTS: Feasibility was high; 100% accrual, low (5%) attrition, and 100% completion of study sessions. Acceptability was high, with 89% finding the intervention "mostly" or "very" helpful. Engage-PA participants demonstrated improvements in arthritis pain severity (Mdiff = 1.68, p = 0.044, 95% CI [- 0.26, 3.62]) and self-reported activity (Mdiff = 0.875, p = 0.038, 95% CI [- 1.85, 0.98]) from baseline to post-treatment as compared to TAU+. Due to pandemic-related challenges, there was a high level of missing data (43%) for daily steps, but available data showed no significant change in steps over time or between the groups. COVID-19 added an additional burden to participants, such that 50% were exercising less, 68% were more sedentary, and 72% lost access to spaces and social support to be active. CONCLUSIONS: Engage-PA is a promising brief, novel behavioral intervention with the potential to support older adults in improving arthritis-related pain and functioning and increasing physical activity. The feasibility and acceptability of Engage-PA are particularly notable as most participants reported COVID-19 added more barriers to physical activity. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04490395 . Registered on July 29, 2020.

Relationship between social support, physical symptoms, and depression in women with breast cancer and pain.

PURPOSE: Fatigue and pain are common among women with breast cancer, and often related to depressive symptoms. Social support may influence levels of fatigue, pain interference, and depressive symptoms. We tested a theory-based, structural model examining the relationship between social support (i.e., emotional and instrumental) and depressive symptoms via fatigue and pain interference in women with breast cancer. METHODS: Women (N = 327) with stages I-III breast cancer were enrolled in a randomized trial investigating a behavioral pain intervention. Measures of social support, fatigue, pain interference, and depressive symptoms were completed at enrollment. Data were analyzed using structural equation modeling to test direct and indirect pathways relating social support, fatigue, pain interference, and depressive symptoms. RESULTS: Our model evidenced good fit. Significant direct effects emerged linking higher levels of emotional support with lower levels of fatigue (ß = -.30), pain interference (ß = -.32), and depressive symptoms (ß = -.31). More instrumental support was significantly associated with more depressive symptoms (ß = .11), but not fatigue or pain interference. Higher levels of fatigue (ß = .30) and pain interference (ß = .34) were significantly related to higher levels of depressive symptoms. More emotional support related to less depressive symptoms via lower levels of fatigue (ß = -.09) and pain interference (ß = -.11). CONCLUSION: Women reporting higher levels of emotional support endorsed fewer depressive symptoms, and that relationship was driven by lower levels of fatigue and pain interference. Our results highlight novel pathways that healthcare professionals can leverage to optimize social support topics in psychosocial interventions targeting breast cancer symptoms. This model should be replicated using longitudinal data.

Coping Skills Training and Acceptance and Commitment Therapy for Symptom Management: Feasibility and Acceptability of a Brief Telephone-Delivered Protocol for Patients With Advanced Cancer.

CONTEXT: Patients with advanced cancer face a life-limiting condition that brings a high symptom burden that often includes pain, fatigue, and psychological distress. Psychosocial interventions have promise for managing symptoms but need additional tailoring for these patients' specific needs. Patients with advanced cancer in the community also face persistent barriers-availability of interventions in community clinics as well as financial and illness-related factors-to accessing psychosocial interventions. OBJECTIVES: The aim of the present study was to assess the feasibility and acceptability of telephone implementation of Engage, a novel brief combined Coping Skills Training and Acceptance and Commitment Therapy protocol, for reducing symptoms and increasing quality of life in community patients with advanced cancer. METHODS: Adult patients with advanced cancer receiving care in the community received Engage, four 60-minute manualized telephone sessions delivered by a trained psychotherapist and completed pretreatment and post-treatment assessments. RESULTS: Engage was feasible, achieving 100% accrual (N = 24) of a heterogeneous sample of patients with advanced cancer, with good retention (88% completed). Acceptability was demonstrated via satisfaction (mean 29 of 32; SD 2), engagement (95% attendance), and use of skills. Secondary analyses pointed to reductions in pain interference, fatigue, psychological distress, and improvements in psychological acceptance and engagement in value-guided activity after treatment. CONCLUSION: Engage, our brief novel combined Coping Skills and Acceptance and Commitment Therapy intervention, demonstrated initial feasibility and acceptability when delivered over the telephone and increased access for community clinic patients with advanced cancer. Future research will assess the comparative efficacy of Engage in larger randomized trials.

The efficacy of Focused Acceptance and Commitment Therapy in VA primary care.

Focused Acceptance & Commitment Therapy (FACT) is a brief intervention based on traditional Acceptance and Commitment Therapy (ACT). Although there is a growing body of research on the efficacy of ACT for a variety of populations and disorders, there is little research to date on the use of FACT in group settings. This project is 1 of the first of its kind, as it examines data on psychological flexibility, health and mental health status, and symptom reduction from a 4-week FACT group. Participants in this study were 51 patients who attended this group as part of routine clinical care in a VA integrated primary care and mental health setting. They completed pre- and posttreatment measures of well-being, depression, anxiety, stress, psychological flexibility, and perceptions of physical and mental health functioning. Pre- to posttreatment analyses of variance demonstrated large effects for quality of life, F(1, 51) = 21.29, p < .001, η2 = 0.30, moderate effects for depressive symptoms, F(1, 51) = 11.47, p < .001, η2 = 0.08, and perceptions of mental health functioning (MCS scale), F(1, 51) = 9.67, p = .003, η2 = 0.11, and small effects for perceptions of perceived stress, F(1, 51) = 4.08, p = .04, η2 = 0.03, and physical health functioning (PCS scale), F(1, 51) = 6.60, p = .01, η2 = 0.08. There was a statistical trend for reductions in anxiety, F(1, 51) = 3.29, p = .07, η2 = 0.01, and a nonsignificant effect for psychological flexibility, F(1, 51) = 2.05, p = .16, η2 = 0.04. These data provide initial support for the implementation of a group-based FACT protocol within a VA primary care setting and help to lay a foundation for further, more controlled studies on Group FACT in future research. (PsycINFO Database Record

Acceptance and Commitment Therapy modules: Differential impact on treatment processes and outcomes.

A modular, transdiagnostic approach to treatment design and implementation may increase the public health impact of evidence-based psychosocial interventions. Such an approach relies on algorithms for selecting and implementing treatment components intended to have a specific therapeutic effect, yet there is little evidence for how components function independent of their treatment packages when employed in clinical service settings. This study aimed to demonstrate the specificity of treatment effects for two components of Acceptance and Commitment Therapy (ACT), a promising candidate for modularization. A randomized, nonconcurrent, multiple-baseline across participants design was used to examine component effects on treatment processes and outcomes in 15 adults seeking mental health treatment. The ACT OPEN module targeted acceptance and cognitive defusion; the ACT ENGAGED module targeted values-based activation and persistence. According to Tau-U analyses, both modules produced significant improvements in psychiatric symptoms, quality of life, and targeted therapeutic processes. ACT ENGAGED demonstrated greater improvements in quality of life and values-based activation. ACT OPEN showed greater improvements in symptom severity, acceptance, and defusion. Both modules improved awareness and non-reactivity, which were mutually targeted, though using distinct intervention procedures. Both interventions demonstrated high treatment acceptability, completion, and patient satisfaction. Treatment effects were maintained at 3-month follow up. ACT components should be considered for inclusion in a modular approach to implementing evidence-based psychosocial interventions for adults.

Randomized clinical trial of cognitive behavioral therapy (CBT) versus acceptance and commitment therapy (ACT) for mixed anxiety disorders.

OBJECTIVE: Randomized comparisons of acceptance-based treatments with traditional cognitive behavioral therapy (CBT) for anxiety disorders are lacking. To address this gap, we compared acceptance and commitment therapy (ACT) to CBT for heterogeneous anxiety disorders. METHOD: One hundred twenty-eight individuals (52% female, mean age = 38, 33% minority) with 1 or more DSM-IV anxiety disorders began treatment following randomization to CBT or ACT; both treatments included behavioral exposure. Assessments at pre-treatment, post-treatment, and 6- and 12-month follow-up measured anxiety-specific (principal disorder Clinical Severity Ratings [CSRs], Anxiety Sensitivity Index, Penn State Worry Questionnaire, Fear Questionnaire avoidance) and non-anxiety-specific (Quality of Life Index [QOLI], Acceptance and Action Questionnaire-16 [AAQ]) outcomes. Treatment adherence, therapist competency ratings, treatment credibility, and co-occurring mood and anxiety disorders were investigated. RESULTS: CBT and ACT improved similarly across all outcomes from pre- to post-treatment. During follow-up, ACT showed steeper linear CSR improvements than CBT (p < .05, d = 1.26), and at 12-month follow-up, ACT showed lower CSRs than CBT among completers (p < .05, d = 1.10). At 12-month follow-up, ACT reported higher AAQ than CBT (p = .08, d = 0.42; completers: p < .05, d = 0.56), whereas CBT reported higher QOLI than ACT (p < .05, d = 0.42). Attrition and comorbidity improvements were similar; ACT used more non-study psychotherapy at 6-month follow-up. Therapist adherence and competency were good; treatment credibility was higher in CBT. CONCLUSIONS: Overall improvement was similar between ACT and CBT, indicating that ACT is a highly viable treatment for anxiety disorders.