Ethical, legal, and social implications of digital health: A needs assessment from the Society of Behavioral Medicine to inform capacity building for behavioral scientists.

The ethical, legal, and social implications (ELSIs) of digital health are important when researchers and practitioners are using technology to collect, process, or store personal health data. Evidence underscores a strong need for digital health ELSI training, yet little is known about the specific ELSI topic areas that researchers and practitioners would most benefit from learning. To identify ELSI educational needs, a needs assessment survey was administered to the members of the Society of Behavioral Medicine (SBM). We sought to identify areas of ELSI proficiency and training need, and also evaluate interest and expertise in ELSI topics by career level and prior ELSI training history. The 14-item survey distributed to SBM members utilized the Digital Health Checklist tool (see recode.health/tools) and included items drawn from the four-domain framework: data management, access and usability, privacy and risk to benefit assessment. Respondents (N = 66) were majority faculty (74.2%) from psychology or public health. Only 39.4% reported receiving "formal" ELSI training. ELSI topics of greatest interest included practices that supported participant engagement, and dissemination and implementation of digital tools beyond the research setting. Respondents were least experienced in managing "bystander" data, having discussions about ELSIs, and reviewing terms of service agreements and privacy policies with participants and patients. There is opportunity for formalized ELSI training across career levels. Findings serve as an evidence base for continuous and ongoing evaluation of ELSI training needs to support scientists in conducting ethical and impactful digital health research.

New technologies are increasingly used in research and practice, which introduce new ethical, legal, and social implications (ELSIs). While there are scholars who study ELSIs in research, it is important that behavioral scientists have ELSI training in order to identify and mitigate possible harms and maximize benefits among their patients/participants, particularly when using technologies that collect personal health information. ELSI training opportunities are limited and, because ELSI is a broad complicated field, we know very little about the specific topics that researchers/practitioners would benefit from learning. To understand ELSI training needs specific to the field of digital health, we asked the members of the Society of Behavioral Medicine, a multidisciplinary nonprofit organization, to tell us about which ELSI areas they are most interested in. We found that 39.4% of members received formal ELSI training. Members were most interested in using technology to help patients/participants stay engaged in their treatments, and developing technologies that can be used outside of research (in the "real world"). Members were least experienced in reviewing terms of service/privacy policies and handling information collected from non-patient/participants (people in the backgrounds of voice recordings/videos). Training interests differed by career level (faculty vs. students), and so future ELSI trainings could be more beneficial if they were mindful of prior experiences.

A pilot feasibility study of an unguided, internet-delivered cognitive behavioral therapy program for irritable bowel syndrome.

BACKGROUND: Irritable bowel syndrome (IBS) is linked with lower health-related quality of life. Cognitive behavioral therapy (CBT) designed for IBS management can improve outcomes but further research of more accessible implementations of this treatment approach for IBS is needed. This study assessed the feasibility of a web-delivered CBT program among adults with IBS to apply to a future clinical trial. METHODS: Twenty-five participants were randomized to receive an unguided web-based, CBT program for IBS. The primary outcome was changes in IBS symptom severity (IBS Symptom Severity Scale [IBS-SSS]). Secondary outcomes included IBS-specific CBT therapeutic mechanisms of change (GI-specific anxiety, unhelpful IBS behaviors, and GI-focused cognitions) and changes in depressive (Patient Health Questionnaire-9 [PHQ-9]) and anxiety (Generalized Anxiety Disorder-7 scale [GAD-7]) symptom severity. KEY RESULTS: Among participants randomized to receive web-based CBT, the average baseline IBS-SSS score was 296.3 (SD=100.9). IBS symptom severity significantly improved at 2-month (p < 0.001) and 3-month follow-up (p < 0.0001); the within-group effect size between baseline and 3-month follow-up IBS-SSS scores was large (d = 1.14) and 63.6% experienced a clinically meaningful improvement (ie, ≥50-point IBS-SSS score reduction). GI-specific anxiety symptoms and cognitions significantly improved at 2-month follow-up, as did unhelpful IBS safety behaviors. Additionally, clinically meaningful improvement was observed in depressive and anxiety symptoms at 3-month follow-up among participants with symptoms above the clinical threshold (ie, PHQ-9 ≥ 10 and GAD-7 ≥ 10, respectively) at baseline. CONCLUSIONS & INFERENCES: These preliminary findings warrant a larger trial to investigate an unguided, web-based CBT for IBS symptom management that is powered to detect between-group treatment effects.

Mindfulness and Interoceptive Exposure Therapy for Anxiety Sensitivity in Atrial Fibrillation: A Pilot Study.

Atrial fibrillation is the most common cardiac arrhythmia and symptoms overlap with physiological sensations of anxiety. Patients with atrial fibrillation can demonstrate anxiety sensitivity even in the absence of actual atrial fibrillation symptoms. Interoceptive exposure is effective in treating anxiety sensitivity, and recently, mindfulness has been proposed as an enhancement strategy to facilitating inhibitory learning in exposure therapy. This pragmatic study piloted a brief mindfulness and interoceptive exposure treatment for anxiety sensitivity in atrial fibrillation. Eight participants with atrial fibrillation and elevated anxiety sensitivity from a hospital cardiology department participated in the treatment. Anxiety sensitivity significantly decreased during the course of the intervention. These initial findings show proof of concept for this brief intervention in a cardiac-specific behavioral medicine setting.

Behavior science in the evolving world of digital health: considerations on anticipated opportunities and challenges.

Digital health promises to increase intervention reach and effectiveness for a range of behavioral health outcomes. Behavioral scientists have a unique opportunity to infuse their expertise in all phases of a digital health intervention, from design to implementation. The aim of this study was to assess behavioral scientists' interests and needs with respect to digital health endeavors, as well as gather expert insight into the role of behavioral science in the evolution of digital health. The study used a two-phased approach: (a) a survey of behavioral scientists' current needs and interests with respect to digital health endeavors (n = 346); (b) a series of interviews with digital health stakeholders for their expert insight on the evolution of the health field (n = 15). In terms of current needs and interests, the large majority of surveyed behavioral scientists (77%) already participate in digital health projects, and from those who have not done so yet, the majority (65%) reported intending to do so in the future. In terms of the expected evolution of the digital health field, interviewed stakeholders anticipated a number of changes, from overall landscape changes through evolving models of reimbursement to more significant oversight and regulations. These findings provide a timely insight into behavioral scientists' current needs, barriers, and attitudes toward the use of technology in health care and public health. Results might also highlight the areas where behavioral scientists can leverage their expertise to both enhance digital health's potential to improve health, as well as to prevent the potential unintended consequences that can emerge from scaling the use of technology in health care.

Mindfulness-based therapy for psychogenic nonepileptic seizures.

BACKGROUND: Mindfulness-based therapies (MBTs) are effective in many neuropsychiatric disorders, and represent a potential therapeutic strategy for psychogenic nonepileptic seizures (PNES). OBJECTIVE: The objective of this study was to investigate the clinical effect of a manualized 12-session MBT for PNES in an uncontrolled trial. We hypothesized reductions in PNES frequency, intensity, and duration, and improvements in quality of life and psychiatric symptom severity at treatment completion. METHODS: Between August 2014 and February 2018, 49 patients with documented PNES (with video electroencephalography [EEG]) were recruited at Brigham and Women's Hospital to participate in the MBT for PNES treatment study. Baseline demographic and clinical information and self-rating scales were obtained during the diagnostic evaluation (T0). Baseline PNES frequency, intensity, and duration were collected at the first follow-up postdiagnosis (T1). Frequency was obtained at each subsequent MBT session and analyzed over time with median regression analysis. Outcomes for other measures were collected at the last MBT session (T3), and compared to baseline measures using linear mixed models. RESULTS: Twenty-six patients completed the 12-session MBT program and were included in the analysis. Median PNES frequency decreased by 0.12 events/week on average with each successive MBT session (p = 0.002). At session 12, 70% of participants endorsed a reduction in PNES frequency of at least 50%. Freedom from PNES was reported by 50% of participants by treatment conclusion. Seventy percent reported a 50% reduction in frequency from baseline and 50% reported remission at session 12. By treatment end, PNES intensity decreased (p = 0.012) and quality of life improved (p = 0.002). Event duration and psychiatric symptom severity were lower after treatment, but reductions were not statistically significant. CONCLUSIONS: Completion of a manualized 12-session MBT for PNES provides improvement in PNES frequency, intensity, and quality of life. The high dropout rate is consistent with adherence studies in PNES. Possible reasons for dropout are discussed. Randomized controlled trials and longer-term outcomes are needed to demonstrate the efficacy of MBT in PNES.

Guided Digital Cognitive Behavioral Program for Anxiety in Primary Care: Propensity-Matched Controlled Trial.

BACKGROUND: Cognitive behavioral therapy (CBT) is the gold standard treatment for adult anxiety disorders but is often not readily available in a scalable manner in many clinical settings. OBJECTIVE: This study examines the feasibility, acceptability, and effectiveness of a coach-facilitated digital cognitive behavioral program for anxious adults in primary care. METHODS: In an open trial, patients who screened positive for anxiety (General Anxiety Disorder-7 [GAD7] score ≥5) were offered the digital cognitive behavioral program (active group, n=593). Primary outcomes included anxiety, quality of life (QoL), and ambulatory medical use over 6 months. Intent-to-treat (ITT) and modified intent-to-treat (mITT) analyses were completed. Subsequently, we compared the outcomes of participants with those of a matched control group receiving primary care as usual (CAU; n=316). RESULTS: More than half of the patients downloaded the cognitive behavioral mobile app program and about 60% of these were considered engaged, which was defined as completion of ≥3 techniques. The active group demonstrated medium size effects on reducing anxiety symptoms (effect size d=0.44; P<.001) and improving mental health QoL (d=0.49; P<.001) and showed significantly improved physical health QoL (d=0.39; P=.002) and a decreased likelihood of high utilization of outpatient medical care (odds ratio=0.49; P<.001). The active group did not significantly outperform the CAU group in anxiety reduction or QoL improvement (d=0.20; P=.07). However, intent-to-treat analysis showed that the active group had a significantly lower likelihood of high utilization of outpatient medical care than the enhanced CAU group (P<.0001; odds ratio=0.09). CONCLUSIONS: A coach-facilitated digital cognitive behavioral program prescribed in primary care is feasible and acceptable. Primary care patients prescribed a digital cognitive behavioral program for anxiety experienced significant improvements in anxiety symptoms, QoL, and reduced medical utilization. This effect was observed even among patients with chronic medical conditions and behavioral health comorbidities. Although the primary outcomes in the active group did not improve significantly more than the CAU group, health care utilization declined, and some secondary outcomes improved in participants who engaged in the program compared to the CAU group. TRIAL REGISTRATION: ClinicalTrials.gov NCT03186872; https://clinicaltrials.gov/ct2/show/NCT03186872.

Quality of Life and Psychosocial Functioning 2 Years Following Facial Transplantation.

BACKGROUND: Face transplantation is a novel option for patients with severe facial disfigurement. Quality of life (QoL) outcomes of face transplantation remain poorly understood. OBJECTIVES: We sought to evaluate psychosocial functioning among 6 patients undergoing facial transplantation. METHODS: We prospectively assessed depressive symptoms, health status, mental and physical QoL, and self-esteem at 3-month intervals for 2 years. Social desirability was assessed pretransplant. RESULTS: On average, before transplantation, patients generally reported minimal to subthreshold depressive symptoms, normal to high health status, normal mental-health QoL, slightly below normal physical-health QoL, and normal to high self-esteem. Most endorsed high social desirability. As patients recovered from surgery, hospitalization, and immunosuppression induction, physical-health QoL generally deteriorated 3 months posttransplantation. Posttransplant trajectories show that perceived health state improved; health status and mental and physical health-related QoL slightly improved; self-esteem remained stable and high; and overall depressive symptoms remained stable but 3 patients experienced a depressive episode. CONCLUSIONS: Pretransplant ceiling effects may render improvements difficult to quantify. Future research should use mixed methods including population-specific measures with demonstrated sensitivity to change.

Implementation of a Guided, Digital Cognitive Behavioral Program for Anxiety in Primary Care: Preliminary Findings of Engagement and Effectiveness.

BACKGROUND: Implementation of digital behavioral health programs in primary care (PC) can improve access to care for patients in need. INTRODUCTION: This study provides preliminary data on user engagement and anxiety symptom change among patients referred by their PC provider to a guided, mobile cognitive behavioral program, Lantern. MATERIALS AND METHODS: Adults aged 20-65 years with at least mild anxiety (GAD-7 ≥ 5) during routine clinical screening in two PC practices were offered Lantern. The primary outcome was self-reported anxiety collected at baseline and 2 months. Linear mixed effects modeling was used to examine anxiety symptom reduction from baseline to 2 months. Post hoc analyses evaluated how number of units completed, number of techniques practiced, and days of usage impacted symptom change. RESULTS: Sixty-three participants signed up for Lantern and had both baseline and 2- month GAD-7. A mixed effects model adjusted for age, gender, medical complexity score, and physical health found a significant effect of time on GAD-7 (ß = -2.08, standard error = 0.77, t(62) = -2.71, p = 0.009). Post hoc analyses indicated that mean number of units, techniques, and usage days did not significantly impact GAD-7 change over 2 months. However, there was significantly greater improvement in anxiety in participants who completed at least three techniques. DISCUSSION: Results benchmark to previous studies that have found statistically significant symptom change among participants after 4-9 weeks of face-to-face or Internet-based cognitive behavioral therapy (CBT). CONCLUSIONS: This study suggests that use of Lantern is associated with anxiety reduction and provides proof-of-concept for the dissemination and implementation of guided, CBT-based mobile behavioral health interventions in PC settings.

A study protocol for a non-randomised comparison trial evaluating the feasibility and effectiveness of a mobile cognitive-behavioural programme with integrated coaching for anxious adults in primary care.

INTRODUCTION: Generalised anxiety disorder (GAD) and subclinical GAD are highly prevalent in primary care. Unmanaged anxiety worsens quality of life in patients seen in primary care practices and leads to increased medical utilisation and costs. Programmes that teach patients cognitive-behavioural therapy (CBT) techniques have been shown to improve anxiety and to prevent the evolution of anxiety symptoms to disorders, but access and engagement have hampered integration of CBT into medical settings. METHODS AND ANALYSIS: This pragmatic study takes place in University of Pittsburgh Medical Center primary care practices to evaluate a coach-supported mobile cognitive- behavioural programme (Lantern) on anxiety symptoms and quality of life. Clinics were non-randomly assigned to either enhanced treatment as usual or Lantern. All clinics provide electronic screening for anxiety and, within clinics assigned to Lantern, patients meeting a threshold level of mild anxiety (ie, >5 on Generalised Anxiety Disorder 7-Item Questionnaire (GAD-7)) are referred to Lantern. The first study phase is aimed at establishing feasibility, acceptability and effectiveness. The second phase focuses on long-term impact on psychosocial outcomes, healthcare utilisation and clinic/provider adoption/sustainable implementation using a propensity score matched parallel group study design. Primary outcomes are changes in anxiety symptoms (GAD-7) and quality of life (Short-Form Health Survey) between baseline and 6-month follow-ups, comparing control and intervention. Secondary outcomes include provider and patient satisfaction, patient engagement, durability of changes in anxiety symptoms and quality of life over 12 months and the impact of Lantern on healthcare utilisation over 12 months. Patients from control sites will be matched to the patients who use the mobile app. ETHICS AND DISSEMINATION: Ethics and human subject research approval were obtained. A data safety monitoring board is overseeing trial data and ethics. Results will be communicated to participating primary care practices, published and presented at clinical and scientific conferences. TRIAL REGISTRATION NUMBER: NCT03035019.

Quality of Life after Face Transplantation: Outcomes, Assessment Tools, and Future Directions.

BACKGROUND: Face transplantation has emerged as a clinical reality for the restoration of complex facial defects. Critical to the advancement of the burgeoning field of reconstructive transplantation is the quality of the methods used to measure and report the impact of face transplantation on quality of life. METHODS: A systematic search using PubMed and EMBASE was conducted for all studies matching the a priori inclusion criteria from 2005 through 2015. Bibliographies of included studies were also reviewed. Two authors (M.A.A and H.K) independently performed screening of titles. RESULTS: The authors identified 17 articles reporting on quality-of-life outcomes among 14 face transplant recipients. Combinations of objective and subjective measures were used to assess quality of life. Instruments used to assess quality of life after face transplantation included over 25 different instruments. Four centers, comprising eight patients, have reported using prospective, systematic data with validated instruments. Overall, there is reported improvement in quality of life after face transplantation. Heterogeneity and a paucity of data between articles preclude a quantitative analysis. CONCLUSIONS: Anecdotal and subjective reports of improvements in quality of life after face transplantation constitute the majority of reported outcomes in the English peer-reviewed literature. Improved efforts in methods and standardization of collection and reporting of quality-of-life data after face transplantation are needed to better appreciate the impact of face transplantation on quality of life and justify lifelong immunosuppression and its attendant risks and morbidity.

What is a good medical decision? A research agenda guided by perspectives from multiple stakeholders.

Informed and shared decision making are critical aspects of patient-centered care, which has contributed to an emphasis on decision support interventions to promote good medical decision making. However, researchers and healthcare providers have not reached a consensus on what defines a good decision, nor how to evaluate it. This position paper, informed by conference sessions featuring diverse stakeholders held at the 2015 Society of Behavioral Medicine and Society for Medical Decision Making annual meetings, describes key concepts that influence the decision making process itself and that may change what it means to make a good decision: interpersonal factors, structural constraints, affective influences, and values clarification methods. This paper also proposes specific research questions within each of these priority areas, with the goal of moving medical decision making research to a more comprehensive definition of a good medical decision, and enhancing the ability to measure and improve the decision making process.

Psychosocial Outcomes after Bilateral Hand Transplantation.

UNLABELLED: Since the first successful hand transplantation in 1998, there have been multiple reports about surgical technique, transplant survival, and immunosuppression. However, very limited published data exist on psychosocial outcomes following hand transplantation. METHODS: We report psychosocial outcomes in a patient with bilateral hand transplants at the midforearm level with serial follow-ups over 3.5 years. Different metrics used to study psychosocial outcomes included the following: SF-12, CES-D, Dyadic Adjustment Scale, Rosenberg SE, and EQ-5D. RESULT: Preoperatively, our patient did not have any evidence of depression (CES-D = 3), had a nonstressful relationship with his spouse (Dyadic Adjustment Scale = 100), and self-esteem was in the normal range (Rosenberg SE = 21). These metrics and his additional scales (SF-12 MCS, EQ-5D, and EQ-VAS) did not change appreciably and were within the normal range for the entire duration of 3.5-year follow-up at all different time points. CONCLUSION: With the increasing popularity of hand transplantation and the increasing awareness of the importance of psychosocial parameters in overall success, appropriate, comprehensive, and standardized measurements are important. These should be an integral part of patients' screening and follow-up.

Psychiatry department response to the Boston Marathon bombings within a level-1 trauma center.

In this article we present how the consultation-liaison and psychology divisions of an academic medical center's Department of Psychiatry responded in the first week after the Boston Marathon bombings, specifically in the context of disaster response guidelines and evidence-based approaches to acute trauma. Since the department had to address several complicated matters at multiple levels within the hospital system, we highlight unexpected issues unique to this particular event as they arose within the primary domains of our involvement. This article aims to (1) provide a descriptive analysis of how we enacted disaster and trauma guidelines and evidence-based care within a hospital setting, (2) shed light on the unique and unexpected administrative and systemic issues encountered in our response, and (3) discuss lessons learned, including opportunities to improve trauma-related care.

Treatment of psychogenic nonepileptic seizures: updated review and findings from a mindfulness-based intervention case series.

Psychogenic nonepileptic seizures (PNES) were first described in the medical literature in the 19th century, as seizure-like attacks not related to an identified central nervous system lesion, and are currently classified as a conversion disorder, according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5). While a universally accepted and unifying etiological model does not yet exist, several risk factors have been identified. Management of PNES should be based on interdisciplinary collaboration, targeting modifiable risk factors. The first treatment phase in PNES is patient engagement, which is challenging given the demonstrated low rates of treatment retention. Acute interventions constitute the next phase in treatment, and most research studies focus on short-term evidence-based interventions. Randomized controlled pilot trials support cognitive-behavioral therapy. Other psychotherapeutic and psychopharmacological interventions have been less well-studied using controlled and uncontrolled trials. Within the discussion of acute interventions, we present a preliminary evaluation for feasibility of a mindfulness-based psychotherapy protocol in a very small sample of PNES patients. We demonstrated in 6 subjects that this intervention is feasible in real-life clinical scenarios and warrants further investigation in larger scale studies. The final treatment phase is long-term follow-up. Long-term outcome studies in PNES show that a significant proportion of patients remains symptomatic and experiences continued impairments in quality of life and functionality. We believe that PNES should be understood as a disease that requires different types of intervention during the various phases of treatment.

Cannabis use and HIV antiretroviral therapy adherence and HIV-related symptoms.

Occasional cannabis use has been associated with increased antiretroviral therapy (ART) adherence and relief of HIV symptoms, while heavy use has been associated with low ART adherence and negative psychological symptoms. The purpose of the present study was to investigate differences between non-cannabis use (NC), non-dependent cannabis use (C), and dependent use (CD) in terms of ART adherence and HIV symptoms/ART side effects. A cross-sectional sample of 180 HIV+ individuals (78.3 % male) completed measures of substance use and psychopathology, medication adherence, and HIV symptoms/ART side effects. Adherence was also measured via pill count, viral load, and CD4 count. Results indicated that the CD group reported lower adherence and greater HIV symptoms/ART side effects than the other two groups, with no differences observed between NC and C groups. There is a clinical need to address dependent cannabis use among those prescribed ART. Further examination is needed to ascertain the functions of cannabis use among individuals with HIV.

Differential associations between perceived and objective measurement of distress tolerance in relation to antiretroviral treatment adherence and response among HIV-positive individuals.

The present study sought to extend prior work, showing an association between self-reported distress tolerance and self-reported antiretroviral treatment (ART) adherence, by conducting a multimethod test of the association between distress tolerance and objective measures of ART adherence among a sample of 140 individuals (23.6% female) with human immunodeficiency virus (HIV). Findings indicated that, after accounting for negative affectivity and ART side-effect severity, distress tolerance was significantly associated with pill count adherence as well as viral load. Specifically, a differential association was observed whereby self-reported distress tolerance was associated with pill count adherence, whereas behavioral distress tolerance was associated with viral load. Importantly, no associations were observed between either measure of distress tolerance and CD4 count. Findings are discussed in terms of the importance of both behavioral and perceived distress tolerance assessment among patients with HIV as well as potential clinical implications related to the integration of distress tolerance-focused treatments into existing interventions for individuals with HIV.

Breaking down the barriers to hepatitis C virus (HCV) treatment among individuals with HCV/HIV coinfection: action required at the system, provider, and patient levels.

The majority of hepatitis C virus (HCV) and human immunodeficiency virus (HIV) coinfection occurs among persons who inject drugs. Rapid improvements in responses to HCV therapy have been observed, but liver-related morbidity rates remain high, given notoriously low uptake of HCV treatment. Advances in HCV therapy will have a limited impact on the burden of HCV-related disease at the population-level unless barriers to HCV education, screening, evaluation, and treatment are addressed and treatment uptake increases. This review will outline barriers to HCV care in HCV/HIV coinfection, with a particular emphasis on persons who inject drugs, proposing strategies to enhance HCV treatment uptake and outcomes.

Correlates of hazardous drinking among Veterans with and without hepatitis C.

Hazardous drinking is a major barrier to antiviral treatment eligibility among hepatitis C (HCV) patients. We evaluated differences in substance-related coping, drinking-related consequences, and importance and confidence in ability to change alcohol use among hazardous drinkers with and without HCV (N = 554; 93.5% male). We examined group differences between HCV+ patients (n = 43) and their negative HCV counterparts (n = 511). Results indicate a higher percentage of HCV+ patients report using substances to cope with possible symptoms of PTSD (P < .05) and depression (P < .01), and endorse more lifetime drinking-related negative consequences than HCV patients (P < .01). Furthermore, HCV+ patients place greater importance on changing alcohol use (P < .01) but report less confidence in their ability to change (P < .01). Use of brief assessment and feedback with skills-based interventions to decrease alcohol use may be well-received by HCV+ patients.

Pain anxiety, acceptance, and outcomes among individuals with HIV and chronic pain: a preliminary investigation.

The current study investigated the role of during treatment changes in pain anxiety in the relation between during treatment changes in pain acceptance and chronic pain outcomes. Participants included 45 (15 women) adults (M(age) = 50.42, SD = 7.69) who were HIV positive and experienced chronic pain. They were offered 12 weekly, 90-min group CBT sessions to increase understanding about chronic pain and to improve coping skills. Four hierarchical regression analyses were conducted to examine the mediating role of treatment changes in pain anxiety in the relation between treatment changes in pain acceptance and chronic pain outcomes. Results suggest that increases in pain acceptance during treatment were associated with decreased levels of pain anxiety during treatment, as well as decreases in pain-related impairment at treatment completion. Furthermore, decreases in pain anxiety during treatment were associated with decreases in pain-related impairment at treatment completion. Finally, treatment changes in pain anxiety were found to partially mediate the association between treatment changes in pain acceptance and pain-related impairment at treatment completion. Results are discussed within the context of better understanding the processes of change within a CBT model for chronic pain patients.

Changes in depressive symptoms and impact on treatment course among hepatitis C patients undergoing interferon-α and ribavirin therapy: a prospective evaluation.

OBJECTIVES: Accounting for severity of depressive symptoms at baseline (pretreatment), this study describes (i) depressive symptom change over the course of antiviral treatment among patients with hepatitis C virus (HCV), and (ii) the relationship of such symptom change to treatment duration and response. METHODS: Depressive symptoms, measured with the Beck Depression Inventory (BDI), were examined prospectively among 129 HCV patients (95% male) who endorsed minimal (n=91), mild (n=28), or moderate depressive symptoms (n=10) prior to commencement of antiviral therapy. Assessments were obtained at baseline, 2 weeks, 4 weeks, and thereafter at 4-week intervals until treatment was discontinued or completed. RESULTS: The average depression score of the participants prior to commencing treatment was 7.4 (minimal depression). Depressive symptoms increased over the course of treatment, with average scores of 12.6 (mild depression) at the final assessment at the end of treatment. Patients with mild depressive symptoms at baseline demonstrated the greatest increase (M(increase)=12.7) and the greatest change (M(Δ)=5.8) in depressive symptoms from baseline to treatment completion. Patients who were minimally depressed at baseline completed the least amount of treatment (74%). Likewise, minimally depressed patients were less likely than mildly and moderately depressed patients to attain an antiviral treatment response. CONCLUSIONS: Depressive symptoms may worsen during antiviral therapy among patients with HCV. Notable changes in patients with subclinical depressive symptoms at baseline may be of significant concern, as the present work suggests that their depressive symptom changes are the most unstable. Thus, findings suggest that the degree of within treatment symptom change may be a more useful predictor (compared with baseline depression status) of ability to tolerate treatment. As the findings of the present study are preliminary, we urge further research and replication before drawing firm conclusions.