Study protocol for a revised randomized trial: Remotely delivered Tai Chi and wellness for Gulf War illness.

BACKGROUND: Many of the 700,000 American military personnel deployed to the Persian Gulf region in 1990 and 1991 have since reported health symptoms of unknown etiology. This cluster of symptoms has been labeled Gulf War Illness and include chronic musculoskeletal pain, fatigue, headaches, memory and attention difficulties, gastrointestinal complaints, skin abnormalities, breathing problems, and mood and sleep problems [1,2]. There have been few high-quality intervention trials and no strong evidence to support available treatments [3]. Tai Chi is an ancient Chinese martial art with benefits that include enhancing physical and mental health and improving quality of life for those with chronic conditions. PROPOSED METHODS: In this randomized controlled trial, GW Veterans are randomly assigned to either Tai Chi or a Wellness control condition, with both remotely delivered intervention groups meeting twice a week for 12 weeks. The primary aim is to examine if Tai Chi is associated with greater improvements in GWI symptoms in Veterans with GWI compared to a Wellness intervention. Participants will receive assessments at baseline, 12 weeks (post-intervention), and follow-up assessments 3- and 9-months post-intervention. The primary outcome measure is the Brief Pain Inventory that examines pain intensity and pain interference. CONCLUSION: This trial will produce valuable results that can have a meaningful impact on healthcare practices for GWI. If proven as a helpful treatment for individuals with GWI, it would support the implementation of remotely delivered Tai Chi classes that Veterans can access from their own homes.

Tai Chi and Qigong for trauma exposed populations: A systematic review.

Background: Trauma exposure and posttraumatic stress are highly prevalent and comorbid with health problems. Despite the apparent systemic nature of post-traumatic stress, recommended treatments neglect trauma's deleterious effects on health. Integrative mind-body treatments for posttraumatic stress, such as Tai Chi and Qigong (TCQ), may offer a promising adjunct to first-line treatments. Method: A systematic search was conducted to identify trials that examined Tai Chi and/or Qigong as treatments for trauma-exposed populations. Studies were examined for rigor; design, sample and intervention characteristics, dropout, attendance, satisfaction, acceptability, and key findings were systematically extracted. Results: The 6 studies included are all pilot or feasibility trials with descriptive or mixed-methods outcomes. No randomized trials or rigorous studies were identified. Dropout rates ranged widely, and adverse reactions were not evident. Reported satisfaction was high and benefits of relaxation, reductions in mental health symptoms, and improvements in pain and physical and cognitive functioning were noted. Limitations: All the studies were non-rigorous and relatively small, with no comparison groups, or follow-up assessments; in many cases, posttraumatic stress symptoms were not formally assessed. Conclusions: The paucity and lack of rigor of the studies identified for this review highlights the need for larger, methodologically sound clinical trials. The reviewed studies suggest that TCQ practices have the potential to reduce symptoms and improve functioning for individuals exposed to trauma and provide evidence that TCQ is feasible, acceptable, and low risk in these populations. Possible mechanistic pathways supporting TCQ as a treatment for posttraumatic stress are considered.

Fallen Between the Cracks: Protecting Research Staff From Participant-Perpetrated Harassment.

There has been a call to identify populations who are at-risk for harassment. At our institution, participant-perpetrated harassment led to the development of an institution-wide program called Cultivating Respect in Research Environments (CuRRE). In this article, we describe the proactive and multipronged approach used to promote and implement the CuRRE program. We describe a policy created to set guidelines and expectations for research participants and discuss the educational and skills-based trainings delivered to principal investigators and research staff members. Research staff members completed anonymous surveys before and after the training. Over half of the attendees reported having been harassed by a participant/patient. Attendees responded favorably to the training; they felt more confident and better equipped to address participant-perpetrated harassment at the conclusion of the training. Given the dearth of literature in this area, we offer our experiences to encourage others to address this issue within their own research environment and institution.

The Assessment of Readiness and Consent for Hormone Therapy: A Semi-structured Interview for Use With Transgender and Gender Nonconforming Individuals.

BACKGROUND: Evaluations to determine one's readiness to initiate hormone therapy are often requested by endocrinologists or institutions who provide gender-affirming hormone therapy for transgender adults. Unfortunately, many mental health providers report unfamiliarity in working with gender-nonconforming individuals and with the needs of this population, and do not feel equipped to conduct these evaluations. OBJECTIVES: The purpose of this paper is to introduce an instrument that can guide providers to conduct a hormone readiness evaluation that is consistent with the current best practices model of care put forth by the World Professional Association for Transgender Health Standards of Care. METHODS: Development of the Assessment of Readiness and Consent for Hormone Therapy (ARCH) was informed by published literature and consultation with subject matter experts. The tool has been revised through an iterative approach based on provider experience and client feedback. RESULTS: The ARCH has been used as part of a national training initiative in transgender healthcare and favorable feedback has been received. Providers have reported that using the ARCH has increased their confidence in their ability to provide sensitive care that is consistent with best practice recommendations. CONCLUSIONS: Use of the ARCH has the potential to enhance care for a population that often encounters poor access to culturally competent providers and treatments. The focused nature of the interview helps providers support and advocate for their clients by providing and gathering information necessary to make meaningful recommendations that will help hormone treatment candidates enhance their gender related quality of life.

Acceptability of a Wellness Group Program for Veterans With Symptoms of Posttraumatic Stress Disorder.

BACKGROUND: Although there are effective evidence-based treatments for posttraumatic stress disorder (PTSD), many individuals drop out or do not benefit from treatment. There is a need for new treatments, including approaches that are nontrauma focused. OBJECTIVE: The purpose of this program evaluation was to investigate the acceptability of a Wellness Group designed to promote healthy behaviors and adaptive coping when offered to veterans with PTSD. METHODS: Nine veterans in a PTSD outpatient clinic enrolled in a 12-week, 24-session Wellness Group. Acceptability of the intervention was evaluated with attendance data, questionnaires, and interviews. RESULTS: Group attendance rates were high and no participants dropped out of treatment. Treatment satisfaction was high and all veterans reported gains in at least 3 of the 8 Wellness domains covered. Interview data supported the findings that veterans had positive reactions to the group. CONCLUSION: A Wellness approach may offer a low-cost alternative or supplementary treatment for veterans with PTSD that is highly acceptable and may improve health behaviors, quality of life, and coping skills.

The Effects of Tai Chi Mind-Body Approach on the Mechanisms of Gulf War Illness: an Umbrella Review.

Gulf War illness (GWI) is a chronic and multisymptom disorder affecting military veterans deployed to the 1991 Persian Gulf War. It is characterized by a range of acute and chronic symptoms, including but not limited to, fatigue, sleep disturbances, psychological problems, cognitive deficits, widespread pain, and respiratory and gastrointestinal difficulties. The prevalence of many of these chronic symptoms affecting Gulf War veterans occur at markedly elevated rates compared to nondeployed contemporary veterans. To date, no effective treatments for GWI have been identified. The overarching goal of this umbrella review was to critically evaluate the evidence for the potential of Tai Chi mind-body exercise to benefit and alleviate GWI symptomology. Based on the most prevalent GWI chronic symptoms and case definitions established by the Centers for Disease Control and Prevention and the Kansas Gulf War Veterans Health Initiative Program, we reviewed and summarized the evidence from 7 published systematic reviews and meta-analyses. Our findings suggest that Tai Chi may have the potential for distinct therapeutic benefits on the major prevalent symptoms of GWI. Future clinical trials are warranted to examine the feasibility, efficacy, durability and potential mechanisms of Tai Chi for improving health outcomes and relieving symptomology in GWI.

A systematic review of randomized trials of mind-body interventions for PTSD.

OBJECTIVE: To systematically review outcomes from randomized controlled trials (RCTs) of mind-body treatments for PTSD. METHODS: Inclusion criteria based on guidelines for assessing risk of bias were used to evaluate articles identified through electronic literature searches. RESULTS: Twenty-two RCTs met inclusion standards. In most of the nine mindfulness and six yoga studies, significant between-group effects were found indicating moderate to large effect size advantages for these treatments. In all seven relaxation RCT's, relaxation was used as a control condition and five studies reported significant between-group differences on relevant PTSD outcomes in favor of the target treatments. However, there were large within-group symptom improvements in the relaxation condition for the majority of studies. CONCLUSIONS: Although many studies are limited by methodologic weaknesses, recent studies have increased rigor and, in aggregate, the results for mindfulness, yoga, and relaxation are promising. Recommendations for design of future mind-body trials are offered.

Feasibility, qualitative findings and satisfaction of a brief Tai Chi mind-body programme for veterans with post-traumatic stress symptoms.

OBJECTIVE: To examine feasibility, qualitative feedback and satisfaction associated with a 4-session introduction to Tai Chi for veterans with post-traumatic stress symptoms. DESIGN: We observed and reported recruitment and retention rates, participant characteristics, adherence, and satisfaction across 2 cohorts. We also examined qualitative feedback provided by questionnaires, focus groups and individual interviews. MAIN OUTCOME MEASURES: Rates of recruitment and retention, focus group and individual feedback interviews, self-reported satisfaction. PARTICIPANTS: 17 veterans with post-traumatic stress symptoms. RESULTS: Almost 90% (17/19) of those eligible following the telephone screen enrolled in the programme. Three-quarters (76.4%) of the participants attended at least 3 of the 4 Tai Chi sessions. Qualitative data analysis revealed themes indicating favourable impressions of the Tai Chi sessions. In addition, participants reported feeling very engaged during the sessions, and found Tai Chi to be helpful for managing distressing symptoms (ie, intrusive thoughts, concentration difficulties, physiological arousal). Participants also reported high satisfaction: 93.8% endorsed being very or mostly satisfied with the programme. All participants (100%) indicated that they would like to participate in future Tai Chi programmes and would recommend it to a friend. CONCLUSIONS: Tai Chi appears to be feasible and safe for veterans with symptoms of post-traumatic stress disorder (PTSD), is perceived to be beneficial and is associated with high rates of satisfaction. This study highlights the need for future investigation of Tai Chi as a novel intervention to address symptoms of PTSD.

Targeted recruitment of adults with type 2 diabetes for a physical activity intervention.

Recruiting sufficient numbers of participants for physical activity trials for individuals with diabetes can be difficult because there are often many behavioral demands for participants, and inclusion and exclusion criteria can be extensive. This study examined the recruitment strategies used for a randomized, controlled trial designed to investigate the efficacy of an automated telephone intervention to promote physical activity in adults with type 2 diabetes in an urban Veterans Administration health care system. Traditional recruitment approaches of posting flyers and obtaining referrals from clinicians did not yield sufficient numbers of interested patients. Using the electronic medical record system to identify patients with uncontrolled diabetes allowed staff to send targeted mailings to participants, and 77% of participants were recruited using this method. The targeted mailing approach elicited a positive response rate of 12% (328 of 2,764 potential participants identified) and appeared to produce a more representative and appropriate sample than other recruitment methods used. Lessons learned in this study may be helpful to researchers in future trials who attempt to recruit participants with diabetes for physical activity protocols.

Reasons persons with COPD do not walk and relationship with daily step count.

BACKGROUND: Physical activity (PA) is significantly reduced in persons with COPD. Assessing reasons why persons with COPD do not engage in PA can guide development of effective interventions to promote PA. METHODS: We queried 102 participants with stable COPD about disease-related and general reasons why they do not walk more. The StepWatch Activity Monitor (Orthocare Innovations, Mountlake Terrace, WA, USA) assessed daily step count, a direct measure of PA. Regression models assessed daily step count by response categories, adjusting for age and FEV1 % predicted. RESULTS: Subjects had mean age 72 ± 8 years and mean FEV1 1.48 ± 0.55 L (52 ± 19% predicted). COPD-related worries of becoming short of breath (SOB), needing to use inhalers, or oxygen level becoming low were endorsed by 31, 14, and 12 subjects, respectively. Controlling for age and FEV1% predicted, those who worried about becoming SOB walked an average of 1,329 fewer steps per day than those who did not worry (p = 0.020). Those who worried about needing to use inhalers walked an average of 1,806 fewer steps per day than those who did not worry (p = 0.016). Subjects who were the most motivated and confident walked significantly more than those who were the least motivated and confident. CONCLUSIONS: Presence of COPD-related reasons and lower motivation and confidence are associated with lower daily step count. Management of dyspnea and education about medication use during exercise, and strategies to increase motivation and confidence could facilitate walking in COPD.

Sleep quality as a potential mediator between psychological distress and diabetes quality of life in veterans with type 2 diabetes.

OBJECTIVE: The goal of this study was to explore sleep quality as a potential mediator between depression symptoms and diabetes quality of life (DQOL), and anxiety symptoms and DQOL. METHOD: Participants were 83 male and 3 female veterans with type 2 diabetes (Mage = 62.4). Self-report measures were completed during the baseline assessment of a larger intervention study conducted at the VA Boston Healthcare System. RESULTS: Depression symptoms, anxiety symptoms, and sleep quality were all associated with DQOL. Additionally, sleep quality had a partial indirect effect on the relationships between depression symptoms and DQOL, and between anxiety symptoms and DQOL. CONCLUSIONS: These findings suggest that sleep quality may have an important role in the way that psychological distress affects diabetes quality of life.

A telehealth intervention for veterans on antiviral treatment for the hepatitis C virus.

The standard treatment for chronic hepatitis C (pegylated interferon and ribavirin) causes challenging physical and psychological side effects. The current pilot study evaluated the efficacy of a brief, telephone-based, cognitive-behavioral self-management intervention designed to address mood and quality of life within a sample of veterans on antiviral treatment for hepatitis C. Results from this pilot study support the feasibility of this telehealth intervention, showing that veterans were highly satisfied with the content of the intervention and compliant with the telephone calls. Findings further indicate that symptoms of depression and anxiety and mental health quality of life either remained stable or improved in those participants who received the brief telephone intervention, while those receiving usual care showed significant declines in mood and mental health quality of life. The findings from this study provide evidence that a brief, clinician-administered phone intervention may help individuals on antiviral therapy for hepatitis C to cope more effectively with the negative treatment side effects.

Avoidant coping as a predictor of mortality in veterans with end-stage renal disease.

OBJECTIVE: The aim of this study was to examine the role of active and avoidant coping strategies in predicting mortality in 61 veterans with end-stage renal disease. DESIGN: Participants completed a self-report measure of coping strategies (The COPE; Carver, Scheier, & Weintraub, 1989) and were interviewed as part of a structured assessment to determine their appropriateness for renal transplant. On average, participants were then followed for 9 years via medical record review to determine mortality status. MAIN OUTCOME MEASURES: Mortality, as predicted by factor scores on active and avoidant coping factors estimated via confirmatory factor analysis of select COPE subscales. RESULTS: A Cox regression revealed that a unit change in avoidant coping was associated with a 114% increase in odds of mortality, even after controlling for variance attributable to demographic variables. There was also a statistical trend indicating that this association might be mediated by poor attendance at medical appointments. Active coping did not predict mortality. CONCLUSION: Results demonstrate the importance of assessing coping style in this population; clinical implications of these findings and possible mechanisms of this effect are discussed.

Psychosocial issues and mental health treatment recommendations for patients with hepatitis C.

BACKGROUND: Mental health needs of patients with HCV are increasingly being addressed in medical contexts. OBJECTIVE: The authors review the psychosocial issues relevant to patients with hepatitis C and provide mental health treatment recommendations. FINDINGS: Patients with HCV are faced with a number of challenges, including adjustment to a chronic medical illness, management of symptoms and treatment side effects, and making and maintaining lifestyle changes. Given these issues, mental health clinicians have the opportunity to make a significant contribution to patient care. CONCLUSION: After reviewing the relevant research on these psychosocial issues, the authors have identified areas in which clinicians can intervene; these include adjustment to having a chronic medical illness, coping with stigma and relationship changes, management of side effects, and implementing healthy lifestyle changes.

Psychosocial evaluation for bariatric surgery: the Boston interview and opportunities for intervention.

The process of psychosocial evaluation for weight loss surgery (WLS) is one that goes beyond serving the function of information-gathering (Bauchowitz et al. in Surg Obes Relat Dis 3:554-558, 2007; Friedman et al. in Surg Obes Relat Dis 3:376-382, 2007; Lanyon and Maxwell in Obes Surg 17:321-328, 2007; Sogg and Mori in Obes Surg 14:370-380, 2004; Sogg and Mori in Surg Obes Relat Dis 4:455-463, 2008). This process offers myriad opportunities for delivering significant and powerful interventions that can enhance the patient's success in the WLS process. A discussion of the unique opportunities for psychosocial intervention afforded by the pre-surgical evaluation process is presented, using The Boston Interview for Bariatric Surgery (Sogg and Mori in Surg Obes Relat Dis 4:455-463, 2008) as the organizing framework.

Predictors of exercise compliance in individuals with Gulf War veterans illnesses: Department of Veterans Affairs Cooperative Study 470.

Although the health benefits of exercise for individuals with Persian Gulf War veterans illnesses (GWVI) are documented, many of these individuals do not exercise regularly enough to obtain benefits. The purpose of this study was to investigate factors predicting exercise compliance among individuals with GWVI in a multicenter, randomized, clinical trial. Participants were 1,092 veterans who reported at least two of the following cardinal symptoms of GWVI: (1) fatigue, (2) musculoskeletal pain, and (3) cognitive problems. Participants received exercise alone or exercise and cognitive-behavioral therapy. The overall level of compliance was relatively low during the exercise treatment phase (46.2%) and decreased by one-half during the follow-up period (23.0%). Predictors of compliance during treatment included less pain and greater age, motivation, and body mass index. Predictors of compliance during the follow-up period included less pain and greater age. The results highlight factors that affect adoption and maintenance of physical activity in a population with GWVI.

The Boston interview for gastric bypass: determining the psychological suitability of surgical candidates.

Morbid obesity is a rapidly escalating problem in the United States, one with serious health ramifications. Due to the lack of empirical support for the long-term efficacy of non-surgical interventions for obesity, gastric bypass surgery has been pursued with increasing frequency as a treatment for morbid obesity. Because surgery is a high-risk, invasive treatment option, medical, psychological and behavioral factors must be carefully considered in pre-surgical evaluations. Although psychological evaluations are requested by surgical teams, there is currently no commonly used, standardized protocol for this type of assessment. Further, there is little empirical data specifying which factors predict successful surgical outcomes. A general overview of a semi-structured interview for pre-surgical gastric bypass evaluation, developed by the Medical Psychology Service at the VA Boston Healthcare System, is provided in this paper. This standardized approach has many advantages: it ensures comprehensive assessment of relevant factors; it facilitates both research and training; and it facilitates patient education about the procedure.

Guidelines for conducting a psychiatric evaluation of the unrelated kidney donor.

Living unrelated kidney donors have been increasingly sought out as potential resources for patients with end-stage renal disease. Several psychiatric issues must be factored into the presurgical evaluation of prospective donors. This paper describes a proposed guideline intended to assist clinicians in the psychiatric evaluation of prospective kidney donors. Topics covered in the interview include the prospective donor's stability and ability to make an informed decision, the donor's understanding of the recipient's illness and of the transplant surgery, and extenuating factors that may influence the decision to donate. While efficient and thorough, the guideline is intended to be flexible enough to address the variety of issues that can affect the prospective donor's decision to pursue surgery.