Telehealth Mindfulness-Based Interventions for Chronic Pain: The LAMP Randomized Clinical Trial.

Importance: Although mindfulness-based interventions (MBIs) are evidence-based treatments for chronic pain and comorbid conditions, implementing them at scale poses many challenges, such as the need for dedicated space and trained instructors. Objective: To examine group and self-paced, scalable, telehealth MBIs, for veterans with chronic pain, compared to usual care. Design, Setting, and Participants: This was a randomized clinical trial of veterans with moderate to severe chronic pain, recruited from 3 Veterans Affairs facilities from November 2020 to May 2022. Follow-up was completed in August 2023. Interventions: Two 8-week telehealth MBIs (group and self-paced) were compared to usual care (control). The group MBI was done via videoconference with prerecorded mindfulness education and skill training videos by an experienced instructor, accompanied by facilitated discussions. The self-paced MBI was similar but completed asynchronously and supplemented by 3 individual facilitator calls. Main Outcomes and Measures: The primary outcome was pain-related function using the Brief Pain Inventory interference scale at 3 time points: 10 weeks, 6 months, and 1 year. Secondary outcomes included biopsychosocial outcomes: pain intensity, physical function, anxiety, fatigue, sleep disturbance, participation in social roles and activities, depression, patient ratings of improvement of pain, and posttraumatic stress disorder. Results: Among 811 veterans randomized (mean [SD] age, 54.6 [12.9] years; 387 [47.7%] women), 694 participants (85.6%) completed the trial. Averaged across all 3 time points, pain interference scores were significantly lower for both MBIs compared to usual care (group MBI vs control difference: -0.4 [95% CI, -0.7 to -0.2]; self-paced vs control difference: -0.7 [95% CI, -1.0 to -0.4]). Additionally, both MBI arms had significantly better scores on the following secondary outcomes: pain intensity, patient global impression of change, physical function, fatigue, sleep disturbance, social roles and activities, depression, and posttraumatic stress disorder. Both group and self-paced MBIs did not significantly differ from one another. The probability of 30% improvement from baseline compared to control was greater for group MBI at 10 weeks and 6 months, and for self-paced MBI, at all 3 time points. Conclusions and Relevance: In this randomized clinical trial, scalable telehealth MBIs improved pain-related function and biopsychosocial outcomes compared to usual care among veterans with chronic pain. Relatively low-resource telehealth-based MBIs could help accelerate and improve the implementation of nonpharmacological pain treatment in health care systems. Trial Registration: ClinicalTrials.gov Identifier: NCT04526158.

Relationships Between Applied Mindfulness Practice, Chronic Pain, and Pain-Related Functioning in Veterans.

Mindfulness-based interventions (MBIs) have been shown to improve chronic pain and associated conditions like depression, anxiety, and sleep disorders. However, there is limited research on how veterans with chronic pain apply mindfulness skills to manage pain in daily life. This cross-sectional study examined the association between applied mindfulness practice, pain, and several pain-related conditions among 1,737 veterans with chronic pain prior to enrollment in a trial of 2 MBIs. Applied mindfulness practice was assessed using the Applied Mindfulness Process Scale (AMPS). The outcomes included pain interference, pain intensity, pain catastrophizing, fatigue, sleep disturbance, anxiety, depression, post-traumatic stress disorder, physical function, and social participation. Higher overall AMPS scores, as well as the positive and negative emotional regulation subscales of the AMPS, were associated with less pain interference and catastrophizing, as well as better outcomes for all pain-related conditions. The positive emotional regulation subscale had the strongest associations with outcomes. There was no significant association between the AMPS and pain intensity. The results suggest applied mindfulness practice, especially positive emotional regulation, may improve pain and functioning. In addition, the AMPS shows promise as a process measure of mindfulness skills applied in daily life. Additional research is needed to examine different aspects of mindfulness in the context of MBIs. PERSPECTIVE: This article describes the relationship between applied mindfulness practice and pain-related outcomes, prior to a MBI, using a novel measure of mindfulness practice. These findings underscore the importance of measuring applied mindfulness practice prior to and during clinical interventions to treat chronic pain.

Email recruitment for chronic pain clinical trials: results from the LAMP trial.

BACKGROUND: Recruitment for clinical trials and large-scale studies is challenging, especially for patients with complex conditions like chronic pain. Email recruitment has the potential to increase efficiency, to reduce costs, and to improve access for underrepresented patient populations. The objective of this study was to examine the effectiveness, efficiency, and equitability of email versus postal mail recruitment for the Learning to Apply Mindfulness to Pain (LAMP) study, a three-site clinical trial of mindfulness-based interventions for chronic pain. METHODS: Patients with chronic pain diagnoses were recruited from three United States Department of Veterans Affairs (VA) facilities using the VA electronic health record (EHR). Recruitment materials were sent using either postal mail (n = 7986) or email (n = 19,333). Patients in the email recruitment group were also mailed introductory postcards before any emails. Mailing addresses and email addresses were obtained from the EHR. Effectiveness was measured by the response rate of patients who logged into the secure LAMP study website. Efficiency was measured by the number of days from when the recruitment materials were sent to when patients logged into the LAMP portal as well as the estimated costs of each recruitment approach. To assess equitability, we examined whether email recruitment was less effective for underrepresented populations, based on demographic information from the EHR. RESULTS: Effectiveness-unadjusted response rates were greater for email versus postal-mail recruitment (18.9% versus 6.3%), and adjusted response rates were over three times greater for email recruitment (RR = 3.5, 95% CI 3.1-3.8) based on a multivariable analysis controlling for age, gender, race, ethnicity, rurality, and site. Efficiency-email recruitment had a significantly lower mean response time (1 day versus 8 days) and a lower cost. Equity-email recruitment led to higher response rates for all subpopulations, including older, non-White, Hispanic, rural, and female Veterans. CONCLUSIONS: Email recruitment is an effective, efficient, and equitable way to recruit VA patients to large-scale, chronic pain clinical trials. TRIAL REGISTRATION: Clinical Trial Registration Number: NCT04526158. Patient enrollment began on December 4, 2020.

Gender differences in PTSD severity and pain outcomes: Baseline results from the LAMP trial.

BACKGROUND: Post-traumatic stress disorder (PTSD) and chronic pain are highly prevalent comorbid conditions. Veterans dually burdened by PTSD and chronic pain experience more severe outcomes compared to either disorder alone. Few studies have enrolled enough women Veterans to test gender differences in pain outcomes [catastrophizing, intensity, interference] by the severity of PTSD symptoms. AIM: Examine gender differences in the association between PTSD symptoms and pain outcomes among Veterans enrolled in a chronic pain clinical trial. METHODS: Participants were 421 men and 386 women Veterans with chronic pain who provided complete data on PTSD symptoms and pain outcomes. We used hierarchical linear regression models to examine gender differences in pain outcomes by PTSD symptoms. RESULTS: Adjusted multivariable models indicated that PTSD symptoms were associated with higher levels of pain catastrophizing (0.57, 95% CI [0.51, 0.63]), pain intensity (0.30, 95% CI [0.24, 0.37]), and pain interference (0.46, 95% CI [0.39, 0.52]). No evidence suggesting gender differences in this association were found in either the crude or adjusted models (all interaction p-values<0.05). CONCLUSION: These findings may reflect the underlying mutual maintenance of these conditions whereby the sensation of pain could trigger PTSD symptoms, particularly if the trauma and pain are associated with the same event. Clinical implications and opportunities testing relevant treatments that may benefit both chronic pain and PTSD are discussed.

Using brief reflections to capture and evaluate end-user engagement: a case example using the COMPASS study.

BACKGROUND: Use of participatory research methods is increasing in research trials. Once partnerships are established with end-users, there is less guidance about processes research teams can use to successfully incorporate end-user feedback. The current study describes the use of a brief reflections process to systematically examine and evaluate the impact of end-user feedback on study conduct. METHODS: The Comparative Effectiveness of Trauma-Focused and Non-Trauma- Focused Treatment Strategies for PTSD among those with Co-Occurring SUD (COMPASS) study was a randomized controlled trial to determine the effectiveness of trauma-focused psychotherapy versus non-trauma-focused psychotherapy for Veterans with co-occurring posttraumatic stress disorder and substance use disorder who were entering substance use treatment within the Department of Veterans Affairs. We developed and paired a process of "brief reflections" with our end-user engagement methods as part of a supplemental evaluation of the COMPASS study engagement plan. Brief reflections were 30-minute semi-structured discussions with the COMPASS Team following meetings with three study engagement panels about feedback received regarding study issues. To evaluate the impact of panel feedback, 16 reflections were audio-recorded, transcribed, rapidly analyzed, and integrated with other study data sources. RESULTS: Brief reflections revealed that the engagement panels made recommended changes in eight areas: enhancing recruitment; study assessment completion; creating uniformity across Study Coordinators; building Study Coordinator connection to Veteran participants; mismatch between study procedures and clinical practice; therapist skill with patients with active substance use; therapist burnout; and dissemination of study findings. Some recommendations positively impact study conduct while others had mixed impact. Reflections were iterative and led to emergent processes that included revisiting previously discussed topics, cross-pollination of ideas across panels, and sparking solutions amongst the Team when the panels did not make any recommendations or recommendations were not feasible. CONCLUSIONS: When paired with end-user engagement methods, brief reflections can facilitate systematic examination of end-user input, particularly when the engagement strategy is robust. Reflections offer a forum of accountability for researchers to give careful thought to end-user recommendations and make timely improvements to the study conduct. Reflections can also facilitate evaluation of these recommendations and reveal end-user-driven strategies that can effectively improve study conduct. TRIAL REGISTRATION: ClinicalTrials.gov (NCT04581434) on October 9, 2020; https://clinicaltrials.gov/ct2/show/study/NCT04581434?term=NCT04581434&draw=2&rank=1 .

Exploring Gender Differences in Veterans in a Secondary Analysis of a Randomized Controlled Trial of Mindfulness for Chronic Pain.

Background: Although studies have documented higher rates of chronic pain among women Veterans compared to men Veterans, there remains a lack of comprehensive information about potential contributors to these disparities. Materials and Methods: This study examined gender differences in chronic pain and its contributors among 419 men and 392 women Veterans, enrolled in a mindfulness trial for chronic pain. We conducted descriptive analyses summarizing distributions of baseline measures, obtained by survey and through the electronic health record. Comparisons between genders were conducted using chi-square tests for categorical variables and t-tests for continuous measures. Results: Compared to men, women Veterans were more likely to have chronic overlapping pain conditions and had higher levels of pain interference and intensity. Women had higher prevalence of psychiatric and sleep disorder diagnoses, greater levels of depression, anxiety, post-traumatic stress disorder, fatigue, sleep disturbance, stress and pain catastrophizing, and lower levels of pain self-efficacy and participation in social roles and activities. However, women were less likely to smoke or have a substance abuse disorder and used more nonpharmacological pain treatment modalities. Conclusion: Among Veterans seeking treatment for chronic pain, women differed from men in their type of pain, had greater pain intensity and interference, and had greater prevalence and higher levels of many known biopsychosocial contributors to pain. Results point to the need for pain treatment that addresses the comprehensive needs of women Veterans.Clinical Trial Registration Number: NCT04526158. Patient enrollment began on December 4, 2020.

Treatment-related beliefs and reactions among trauma-focused therapy completers and discontinuers: A qualitative examination.

Prolonged exposure (PE) and cognitive processing therapy (CPT) for posttraumatic stress disorder (PTSD) are effective, but some patients do not respond adequately, and dropout rates are high. Patients' beliefs about treatment and perceptions of treatment components influence treatment outcomes and may be amenable to change through intervention. The present study sought to identify beliefs and reactions to PE and CPT that differentiated completers who screened negative for a PTSD diagnosis after treatment (PTSD-), completers who screened positive for a PTSD diagnosis after treatment (PTSD+), and discontinuers who attended six or fewer sessions. Thematic analysis was used to identify themes in qualitative data collected via retrospective semistructured interviews with 51 completers (19 PTSD- after treatment, 32 PTSD+ after treatment) and 66 discontinuers of PE/CPT. Participants were demographically diverse veterans across service eras. Treatment-related beliefs and reactions differentiating these groups included perceived helpfulness of treatment, self-efficacy in engaging in treatment, anticipatory anxiety and concerns, interpretations of ongoing symptoms, and perceived consequences of treatment on functioning. Further, some patterns seemed to differ in early treatment sessions compared to during the active components of treatment. Findings point to potentially malleable targets that could be intervened upon to improve trauma-focused treatment outcomes. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

The Association Between Racialized Discrimination in Health Care and Pain Among Black Patients With Mental Health Diagnoses.

Chronic pain is a costly and debilitating problem in the United States, and its burdens are exacerbated among socially disadvantaged and stigmatized groups. In a cross-sectional study of Black Veterans with chronic pain at the Atlanta VA Health Care System (N = 380), we used path analysis to explore the roles of racialized discrimination in health care settings, pain self-efficacy, and pain-related fear avoidance beliefs as potential mediators of pain outcomes among Black Veterans with and without an electronic health record-documented mental health diagnosis. In unadjusted bivariate analyses, Black Veterans with a mental health diagnosis (n = 175) reported marginally higher levels of pain-related disability and significantly higher levels of pain interference compared to those without a mental health diagnosis (n = 205). Path analyses revealed that pain-related disability, pain intensity, and pain interference were mediated by higher levels of racialized discrimination in health care and lower pain self-efficacy among Black Veterans with a mental health diagnosis. Pain-related fear avoidance beliefs did not mediate pain outcomes. These findings highlight the need to improve the quality and effectiveness of health care for Black patients with chronic pain through the implementation of antiracism interventions within health care systems. Results further suggest that Black patients with chronic pain who have a mental health diagnosis may benefit from targeted pain management strategies that focus on building self-efficacy for managing pain. PERSPECTIVE: Racialized health care discrimination and pain self-efficacy mediated differences in pain-related disability, pain intensity, and pain interference among Black Veterans with and without a mental health diagnosis. Findings highlight the need for antiracism interventions within health care systems in order to improve the quality of care for Black patients with chronic pain. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT01983228.

The role of symptom accommodation in trauma-focused treatment engagement and response.

Although trauma-focused treatments (TFTs) are generally effective, not all patients improve. Symptom accommodation (i.e., altering one's behavior in response to another's symptoms) by loved ones may be particularly relevant to TFT treatment response and engagement. We examined the role of symptom accommodation by support persons (SPs) in veterans' PTSD treatment response, including the mediating role of treatment engagement and the moderating role of relationship strain. Veterans engaging in prolonged exposure or cognitive processing therapy and a loved one (N = 172 dyads) were sampled at two time points approximately four months apart. Measures of treatment engagement (i.e., highest session completed from the treatment protocol and homework completion) were obtained from hospital records. We found that relationship strain moderated the effect of symptom accommodation on treatment response, ∆R2 = .02. Specifically, Time 1 (T1) accommodation predicted poorer treatment response (i.e., Time 2 [T2] PTSD symptom severity, controlling for T1 symptoms) among veterans who reported below-average relationship strain only. Additionally, symptom accommodation was indirectly related to treatment response such that T1 accommodation predicted higher T2 PTSD symptom severity specifically through reduced homework completion, ß = .01. The findings suggest that attending to accommodating behaviors of veterans' supportive partners may be an important way to boost both engagement in and response to TFTs for PTSD.

Mental health therapy for veterans with PTSD as a family affair: A qualitative inquiry into how family support and social norms influence veteran engagement in care.

Social support is important for posttraumatic stress disorder (PTSD) recovery and emerging literature indicate that social support could increase engagement in PTSD therapy. However, there is a need to understand how and why family involvement can increase treatment engagement to inform strategies used in clinical practice. This study explores how individuals with PTSD and family members of individuals with PTSD experience therapy and how social interactions help or hinder therapy engagement. We interviewed 18 U.S. military veterans who had been referred for psychotherapy for PTSD in the Veterans Health Administration and 13 family members and used rapid content analysis to identify themes. We found that engaging in therapy was a family-level decision that participants expected to improve family life. Veterans were motivated to seek treatment to protect their relationships with loved ones. Family members generally encouraged veterans to seek treatment. Specifically, family members who viewed PTSD as a treatable illness versus a static aspect of the veteran's personality expressed positive attitudes about the effectiveness of therapy for reducing symptoms. Veterans whose social networks included individuals with prior military or trauma-related experiences reported that their loved ones possessed more understanding of PTSD and described positive subjective norms around therapy. Family members are often embedded in the therapy process because PTSD has a profound impact on the family. Positive subjective norms for therapy are created by family encouragement and may influence veteran perceptions about the value of treatment. Family members should be engaged early in mental health therapy and to the extent desired by the patient and family member. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Making sense of poor adherence in PTSD treatment from the perspectives of veterans and their therapists.

OBJECTIVE: Dropout rates from trauma-focused PTSD treatments (TFTs) in VA clinics are particularly high. We conducted in-depth qualitative interviews with 29 veterans and their therapists to better understand this phenomenon. METHOD: Participants were part of a multisite, mixed-methods study of TFT adherence in VA clinics. Veterans were eligible for interviews if they exhibited poor TFT adherence and screened positive for PTSD in follow-up surveys. Interviews were analyzed using qualitative dyadic analysis approaches. RESULTS: Therapists relied on stereotypes of poor adherence to understand veterans' experiences and were missing information critical to helping veterans succeed. Veterans misunderstood aspects of the therapy and struggled in ways they inadequately expressed to therapists. Therapist attempts at course corrections were poorly matched to veterans' needs. Many dyads reported difficulties in their therapeutic relationships. Veterans reported invalidating experiences that were not prominent in therapists' interviews. CONCLUSIONS: Future work is needed to test hypotheses generated and find effective ways to help veterans fully engage in TFTs. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

An Analysis of the Role of Mental Health in a Randomized Trial of a Walking Intervention for Black Veterans With Chronic Pain.

Black patients and those with co-occurring mental health disorders are disproportionately affected by chronic pain, but few interventions target these populations. This is a secondary analysis of a randomized trial of a walking-focused proactive counseling intervention for Black Veterans with chronic musculoskeletal pain (ACTION). The primary aim was to examine intervention effectiveness among Veterans with an electronic health record-documented mental health diagnosis [depressive disorder, anxiety disorder, substance use disorder, post-traumatic stress disorder or serious mental illness (n = 205)] and those without a diagnosis (n = 175). About 380 Black Veterans receiving care at the Atlanta VA Health Care System were enrolled from 2016 to 2019 and randomized to the intervention or usual care (UC) (1:1). The intervention featured 6 telephone coaching sessions over 8-14 weeks to encourage walking. Participants with a mental health disorder were more likely to complete all counseling sessions (56% vs 38%) and reported improvements in global perceptions of pain and pain intensity/interference (secondary outcomes) at 3-months vs UC. Among participants without a mental health disorder, the intervention was associated with an improvement in pain-related disability at 6-months (primary outcome). Black chronic pain patients with co-occurring mental health disorders may require more intensive treatment to affect improvement in pain-related disability. PERSPECTIVE: This study examines the effectiveness of a walking intervention for chronic pain among Black Veterans with a mental health disorder. These patients were more engaged with the intervention than those without a mental health disorder. However, they did not experience reductions in pain-related disability, suggesting more intensive treatment is needed.

Family Involvement in PTSD Treatment: Perspectives from a Nationwide Sample of Veterans Health Administration Clinicians.

Social support is bidirectionally linked to symptoms of posttraumatic stress disorder (PTSD). Evidence suggests that family involvement in veterans' mental health treatment is desired by both veterans and family members, and that such involvement has the potential to improve treatment outcomes. However, rates of family involvement are low in the Veterans Health Administration (VHA). We sought to understand VHA clinicians' perspectives on family involvement in PTSD treatment by conducting qualitative interviews with 31 providers at 10 VHA facilities across the U.S. The i-PARIHS framework was used to guide the interviews and analysis, and several major themes were identified. All clinicians reported that they at least occasionally offered family-inclusive sessions, and they frequently referenced both the influence of family behaviors or attitudes on veterans' functioning, and also how veterans' symptoms could cause tremendous disruption in the family. Clinicians' past experience with supervised family- or couple-based work strongly influenced their current comfort with family-inclusive sessions. Multiple potential avenues exist to support increased family involvement in PTSD treatment in VHA.

Divergent experiences of U.S. veterans who did and did not complete trauma-focused therapies for PTSD: A national qualitative study of treatment dropout.

Prolonged Exposure (PE) and Cognitive Processing Therapy (CPT) are first-line treatments for posttraumatic stress disorder (PTSD) and have been disseminated throughout the U.S. Veterans Health Administration. Treatment non-completion is common and lessens clinical effectiveness; however, prior work has failed to identify factors consistently associated with non-completion. Semi-structured interviews were conducted with a national sample of veterans who recently completed (n = 60) or did not complete (n = 66) PE or CPT. Non-completer interviews focused on factors that contributed to veterans' decisions to drop out and efforts undertaken to complete PE/CPT. Completer interviews focused on challenges faced in completing treatment and facilitators of completion. Transcripts were coded using a mixed deductive/inductive approach; constant comparison was used to identify differences between completers and non-completers. Completers and non-completers differed in the extent of treatment-specific therapist support received, therapists' flexibility in treatment delivery, the type of encouragement offered by the care team and social supports, their interpretation of symptom worsening, the perceived impact of treatment on functioning, and the impact of stressors on their treatment engagement. Treatment-specific therapist support, more patient-centered and flexible treatment delivery, leveraging the full care team, and addressing functional concerns are potential targets for PE and CPT engagement interventions.

Can families help veterans get more from PTSD treatment? A randomized clinical trial examining Prolonged Exposure with and without family involvement.

BACKGROUND: Posttraumatic stress disorder occurs in as many as one in five combat veterans and is associated with a host of negative, long-term consequences to the individual, their families, and society at large. Trauma-focused treatments, such as Prolonged Exposure, result in clinically significant symptom relief for many. Adherence to these treatments (i.e., session attendance and homework compliance) is vital to ensuring recovery but can be challenging for patients. Engaging families in veterans' treatment could prove to be an effective strategy for promoting treatment adherence while also addressing long-standing calls for better family inclusion in treatment for posttraumatic stress disorder. This paper describes the methods of a pragmatic randomized controlled trial designed to evaluate if family inclusion in Prolonged Exposure can improve treatment adherence. METHODS: One hundred fifty-six veterans, with clinically significant symptoms of posttraumatic stress disorder, will be randomized to receive either standard Prolonged Exposure or Prolonged Exposure enhanced through family inclusion (Family-Supported Prolonged Exposure) across three different VA facilities. Our primary outcomes are session attendance and homework compliance. Secondary outcomes include posttraumatic stress disorder symptom severity, depression, quality of life, and relationship functioning. The study includes a concurrent process evaluation to identify potential implementation facilitators and barriers to family involvement in Prolonged Exposure within VA. DISCUSSION: While the importance of family involvement in posttraumatic stress disorder treatment is non-controversial, there is no evidence base supporting best practices on how to integrate families into PE or any other individually focused trauma-focused treatments for posttraumatic stress disorder. This study is an important step in addressing this gap, contributing to the literature for both retention and family involvement in trauma-focused treatments. TRIAL REGISTRATION: ClinicalTrials.gov NCT03256227 . Registered on August 21, 2017.

Taking ACTION to Reduce Pain: a Randomized Clinical Trial of a Walking-Focused, Proactive Coaching Intervention for Black Patients with Chronic Musculoskeletal Pain.

BACKGROUND: Black patients in the USA are disproportionately affected by chronic pain, yet there are few interventions that address these disparities. OBJECTIVE: To determine whether a walking-focused, proactive coaching intervention aimed at addressing contributors to racial disparities in pain would improve chronic pain outcomes among Black patients compared to usual care. DESIGN: Randomized controlled trial with masked outcome assessment ( Clinicaltrials.gov : NCT01983228). PARTICIPANTS: Three hundred eighty Black patients at the Atlanta VA Health Care System with moderate to severe chronic back, hip, or knee pain. INTERVENTION: Six telephone coaching sessions over 8-14 weeks, proactively delivered, using action planning and motivational interviewing to increase walking, or usual care. MAIN MEASURES: Primary outcome was a 30% improvement in pain-related physical functioning (Roland Morris Disability Questionnaire [RMDQ]) over 6 months among Black patients, using intention-to-treat. Secondary outcomes were improvements in pain intensity and interference, depression, anxiety, global impression of change in pain, and average daily steps. KEY RESULTS: The intervention did not produce statistically significant effects on the primary outcome (at 6 months, 32.4% of intervention participants had 30% improvement on the RMDQ vs. 24.7% of patients in usual care; aOR=1.61, 95% CI, 0.94 to 2.77), nor on other secondary outcomes assessed at 6 months, with the exception that intervention participants reported more favorable changes in pain relative to usual care (mean difference=-0.54, 95% CI, -0.85 to -0.23). Intervention participants also experienced a significant reduction in pain intensity and pain interference over 3 months (mean difference=-0.55, 95% CI, -0.88 to -0.22). CONCLUSIONS: A novel intervention to improve chronic pain among Black patients did not produce statistically significant improvements on the primary outcome relative to usual care. More intensive efforts are likely required among this population, many of whom were economically disadvantaged and had mental health comorbidities and physical limitations. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT01983228.

Veterans with poor PTSD treatment adherence: Exploring their loved ones' experience of PTSD and understanding of PTSD treatment.

Trauma-focused psychotherapies such as cognitive processing therapy (CPT) and prolonged exposure (PE) are some of the most effective treatments available for posttraumatic stress disorder (PTSD). These treatments have been widely disseminated and promoted throughout the VA Health care System. However, adherence to and completion of these protocols among veterans is often poor, resulting in diminished impact. "Support persons" (SPs) such as relatives and close friends may provide a source of emotional or practical support in treatment, but little is known about how SPs are involved in or exposed to treatment principles and activities. The primary goal of the current research was to examine the experience of SPs of veterans who had poor adherence to treatment. We were interested in SPs' knowledge about the treatment, their level of involvement in treatment activities or sessions, and their potential interest in more participation or education. Qualitative analyses were used to examine data collected from interviews with 19 SPs of veterans who had an unsuccessful course of CPT or PE. Results indicated generally very low levels of knowledge and treatment participation. However, among most SPs there was substantial interest in the possibility of more treatment involvement, particularly in order to receive guidance from the clinician about how to respond to the veteran's symptoms. We suggest that it is possible and desirable to incorporate loved ones more formally into such protocols. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

A Theory of Planned Behavior Scale for Adherence to Trauma-Focused Posttraumatic Stress Disorder Treatments.

Evidence-based psychotherapies for posttraumatic stress disorder (PTSD), such as cognitive processing therapy and prolonged exposure (CPT/PE), greatly reduce suffering for veterans, but many veterans fail to complete treatment. Developing a theory-based understanding of adherence is necessary to inform interventions to improve treatment retention. We developed and tested a series of scales applying the theory of planned behavior (TPB) to CPT/PE adherence. The scales were administered in mailed surveys as part of a larger mixed-methods study of veteran adherence to PE/CPT. Surveys were sent to 379 veterans who were initiating CPT/PE across four U.S. Veterans Affairs (VA) hospitals and 207 of their loved ones. Subsequent session attendance and homework compliance were coded via a review of electronic medical records. We examined item-level characteristics, factor structure, and the convergent and discriminant validity of the resultant scales. The findings support four subscales: two related to attitudes (i.e., Treatment Makes Sense and Treatment Fits Needs), one related to perceived behavioral control over participation (i.e., Participation Control), and one related to perceived family attitudes about CPT/PE participation (i.e., Subjective Norms). Scale validity was supported through significant associations with theoretically relevant constructs, including intentions to persist in CPT/PE, rs = .19-.38; treatment completion, rs = .21-.25; practical treatment barriers, rs = -.19 to -.24; and therapeutic alliance, rs = .39-.57.

Learning to Apply Mindfulness to Pain (LAMP): Design for a Pragmatic Clinical Trial of Two Mindfulness-Based Interventions for Chronic Pain.

BACKGROUND: Mindfulness-based interventions (MBIs) are evidence-based nonpharmacological treatments for treating chronic pain. However, the predominant MBI, mindfulness-based stress reduction, has features that pose significant implementation barriers. OBJECTIVES: This study will test two approaches to delivering MBIs for improving Veterans' chronic pain and mental health comorbidities. These two approaches address key implementation barriers. METHODS: We will conduct a four-site, three-arm pragmatic randomized controlled trial, Learning to Apply Mindfulness to Pain (LAMP), to test the effectiveness of two MBIs at improving pain and mental health comorbidities. Mobile+Group LAMP consists of prerecorded modules presented by a mindfulness instructor that are viewed in an online group setting and interspersed with discussions led by a facilitator. Mobile LAMP consists of the same prerecorded modules but does not include a group component. We will test whether either of these MBIs will be more effective than usual care at improving chronic pain and whether the Mobile+Group LAMP will be more effective than Mobile LAMP at improving chronic pain. Comparisons for the primary hypotheses will be conducted with continuous outcomes (Brief Pain Inventory interference score) repeated at 10 weeks, 6 months, and 12 months. The secondary hypotheses are that Mobile+Group LAMP and Mobile LAMP will be more effective than usual care at improving secondary outcomes (e.g., post-traumatic stress disorder, depression). We will also confirm the comparisons for the primary and secondary hypotheses in gender-specific strata. IMPLICATIONS: This trial is expected to result in two approaches for delivering MBIs that will optimize engagement, adherence, and sustainability and be able to reach large numbers of Veterans.

Individual Versus Group Cognitive-Behavioral Therapy for Partner-Violent Men: A Preliminary Randomized Trial.

A randomized clinical trial tested the hypothesis that a flexible, case formulation-based, individual treatment approach integrating motivational interviewing strategies with cognitive-behavioral therapy (ICBT) is more efficacious than a standardized group cognitive-behavioral approach (GCBT) for perpetrators of intimate partner violence (IPV). Forty-two men presenting for services at a community domestic violence agency were randomized to receive 20 sessions of ICBT or a 20-week group cognitive-behavioral therapy (CBT) program. Participants and their relationship partners completed assessments of relationship abuse and relationship functioning at baseline and quarterly follow-ups for 1 year. Treatment uptake and session attendance were significantly higher in ICBT than GCBT. However, contrary to the study hypothesis, GCBT produced consistently equivalent or greater benefits than ICBT. Participant self-reports revealed significant reductions in abusive behavior and injuries across conditions with no differential benefits between conditions. Victim partner reports revealed more favorable outcomes for group treatment, including a statistically significant difference in psychological aggression, and differences exceeding a medium effect size for physical assault, emotional abuse, and partner relationship adjustment. In response to hypothetical relationship scenarios, GCBT was associated with greater reductions than ICBT (exceeding a medium effect) in articulated cognitive distortions and aggressive intentions. Treatment competence ratings suggest that flexible, individualized administration of CBT creates challenges in session agenda setting, homework implementation, and formal aspects of relationship skills training. Although caution is needed in generalizing findings from this small-scale trial, the results suggest that the mutual support and positive social influence available in group intervention may be particularly helpful for IPV perpetrators.