Post-9/11 Veterans and Their Partners Improve Mental Health Outcomes with a Self-directed Mobile and Web-based Wellness Training Program: A Randomized Controlled Trial.

BACKGROUND: Veterans with history of deployment in the Global War on Terror face significant and ongoing challenges with high prevalences of adverse psychological, physical, spiritual, and family impacts. Together, these challenges contribute to an emerging public health crisis likely to extend well into the future. Innovative approaches are needed that reach veterans and their family members with strategies they can employ over time in their daily lives to promote improved adjustment and well-being. OBJECTIVE: The objective of this study was to evaluate effects of use of a Web-based, self-directed program of instruction in mind- and body-based wellness skills to be employed by Global War on Terror veterans and their significant relationship partners on mental health and wellness outcomes associated with postdeployment readjustment. METHODS: We recruited 160 veteran-partner dyads in 4 regions of the United States (San Diego, CA; Dallas, TX; Fayetteville, NC; and New York, NY) through publicity by the Iraq and Afghanistan Veterans of America to its membership. Dyads were randomly allocated to 1 of 4 study arms: Mission Reconnect (MR) program alone, MR plus the Prevention and Relationship Enhancement Program (PREP) for Strong Bonds weekend program for military couples, PREP alone, and waitlist control. We administered a battery of standardized and investigator-generated instruments assessing mental health outcomes at baseline, 8 weeks, and 16 weeks. Dyads in the MR arms were provided Web-based and mobile app video and audio instruction in a set of mindfulness-related stress reduction and contemplative practices, as well as partner massage for reciprocal use. All participants provided weekly reports on frequency and duration of self-care practices for the first 8 weeks, and at 16 weeks. RESULTS: During the first 8-week reporting period, veterans and partners assigned to MR arms used some aspect of the program a mean of 20 times per week, totaling nearly 2.5 hours per week, with only modest declines in use at 16 weeks. Significant improvements were seen at 8 and 16 weeks in measures of posttraumatic stress disorder, depression, sleep quality, perceived stress, resilience, self-compassion, and pain for participants assigned to MR arms. In addition, significant reductions in self-reported levels of pain, tension, irritability, anxiety, and depression were associated with use of partner massage. CONCLUSIONS: Both veterans and partners were able to learn and make sustained use of a range of wellness practices taught in the MR program. Home-based, self-directed interventions may be of particular service to veterans who are distant from, averse to, or prohibited by schedule from using professional services. Leveraging the partner relationship may enhance sustained use of self-directed interventions for this population. Use of the MR program appears to be an accessible, low-cost approach that supports well-being and reduces multiple symptoms among post-9/11 veterans and their partners. TRIAL REGISTRATION: Clinicaltrials.gov NCT01680419; https://clinicaltrials.gov/ct2/show/NCT01680419 (Archived by WebCite at http://www.webcitation.org/6jJuadfzj).

Five-week outcomes from a dosing trial of therapeutic massage for chronic neck pain.

PURPOSE: This trial was designed to evaluate the optimal dose of massage for individuals with chronic neck pain. METHODS: We recruited 228 individuals with chronic nonspecific neck pain from an integrated health care system and the general population, and randomized them to 5 groups receiving various doses of massage (a 4-week course consisting of 30-minute visits 2 or 3 times weekly or 60-minute visits 1, 2, or 3 times weekly) or to a single control group (a 4-week period on a wait list). We assessed neck-related dysfunction with the Neck Disability Index (range, 0-50 points) and pain intensity with a numerical rating scale (range, 0-10 points) at baseline and 5 weeks. We used log-linear regression to assess the likelihood of clinically meaningful improvement in neck-related dysfunction (≥5 points on Neck Disability Index) or pain intensity (≥30% improvement) by treatment group. RESULTS: After adjustment for baseline age, outcome measures, and imbalanced covariates, 30-minute treatments were not significantly better than the wait list control condition in terms of achieving a clinically meaningful improvement in neck dysfunction or pain, regardless of the frequency of treatments. In contrast, 60-minute treatments 2 and 3 times weekly significantly increased the likelihood of such improvement compared with the control condition in terms of both neck dysfunction (relative risk = 3.41 and 4.98, P = .04 and .005, respectively) and pain intensity (relative risk = 2.30 and 2.73; P = .007 and .001, respectively). CONCLUSIONS: After 4 weeks of treatment, we found multiple 60-minute massages per week more effective than fewer or shorter sessions for individuals with chronic neck pain. Clinicians recommending massage and researchers studying this therapy should ensure that patients receive a likely effective dose of treatment.

Dosing study of massage for chronic neck pain: protocol for the dose response evaluation and analysis of massage [DREAM] trial.

BACKGROUND: Despite the growing popularity of massage, its effectiveness for treating neck pain remains unclear, largely because of the poor quality of research. A major deficiency of previous studies has been their use of low "doses" of massage that massage therapists consider inadequate. Unfortunately, the number of minutes per massage session, sessions per week, or weeks of treatment necessary for massage to have beneficial or optimal effects are not known. This study is designed to address these gaps in our knowledge by determining, for persons with chronic neck pain: 1) the optimal combination of number of treatments per week and length of individual treatment session, and 2) the optimal number of weeks of treatment. METHODS/DESIGN: In this study, 228 persons with chronic non-specific neck pain will be recruited from primary health care clinics in a large health care system in the Seattle area. Participants will be randomized to a wait list control group or 4 weeks of treatment with one of 5 different dosing combinations (2 or 3 30-min treatments per week or 1, 2, or 3 60-min treatments per week). At the end of this 4-week primary treatment period, participants initially receiving each of the 5 dosing combinations will be randomized to a secondary treatment period of either no additional treatment or 6 weekly 60-min massages. The primary outcomes, neck-related dysfunction and pain, will be assessed by blinded telephone interviewers 5, 12, and 26 weeks post-randomization. To better characterize the trajectory of treatment effects, these interview data will be supplemented with outcomes data collected by internet questionnaire at 10, 16, 20 and 39 weeks. Comparisons of outcomes for the 6 groups during the primary treatment period will identify the optimal weekly dose, while comparisons of outcomes during the secondary treatment period will determine if 10 weeks of treatment is superior to 4 weeks. DISCUSSION: A broad dosing schedule was included in this trial. If adherence to any of these doses is poor, those doses will be discontinued. TRIAL REGISTRATION: This trial is registered in ClinicalTrials.gov, with the ID number of NCT01122836

Randomized clinical trial assessing whether additional massage treatments for chronic neck pain improve 12- and 26-week outcomes.

BACKGROUND CONTEXT: This is the first study to systematically evaluate the value of a longer treatment period for massage. We provide a framework of how to conceptualize an optimal dose in this challenging setting of nonpharmacologic treatments. PURPOSE: The aim was to determine the optimal dose of massage for neck pain. STUDY DESIGN/SETTING: Two-phase randomized trial for persons with chronic nonspecific neck pain. Primary randomization to one of five groups receiving 4 weeks of massage (30 minutes 2x/or 3x/wk or 60 minutes 1x, 2x, or 3x/wk). Booster randomization of participants to receive an additional six massages, 60 minutes 1x/wk, or no additional massage. PATIENT SAMPLE: A total of 179 participants from Group Health and the general population of Seattle, WA, USA recruited between June 2010 and August 2011 were included. OUTCOME MEASURES: Primary outcomes self-reported neck-related dysfunction (Neck Disability Index) and pain (0-10 scale) were assessed at baseline, 12, and 26 weeks. Clinically meaningful improvement was defined as greater than or equal to 5-point decrease in dysfunction and greater than or equal to 30% decrease in pain from baseline. METHODS: Clinically meaningful improvement for each primary outcome with both follow-up times was analyzed using adjusted modified Poisson generalized estimating equations (GEEs). Secondary analyses for the continuous outcomes used linear GEEs. RESULTS: There were no observed differences by primary treatment group at 12 or 26 weeks. Those receiving booster dose had improvements in both dysfunction and pain at 12 weeks (dysfunction: relative risk [RR]=1.56 [1.08-2.25], p=.018; pain: RR=1.25 [0.98-1.61], p=.077), but those were nonsignificant at 26 weeks (dysfunction: RR=1.22 [0.85-1.74]; pain: RR=1.09 [0.82-1.43]). Subgroup analysis by primary and booster treatments found the booster dose only effective among those initially randomized to one of the 60-minute massage groups. CONCLUSIONS: "Booster" doses for those initially receiving 60 minutes of massage should be incorporated into future trials of massage for chronic neck pain.

Yin scores and yang scores: A new method for quantitative diagnostic evaluation in traditional Chinese medicine research.

OBJECTIVE: To develop and evaluate a method for quantitative evaluation of yin and yang (yin and yang scores) in human subjects for the purposes of research. This method aims to classify subjects into groups allowing future quantitative testing of key research questions such as: do different groups of patients respond differently to acupuncture treatments or Chinese herb formulas? METHODS: In a pilot study of inter-rater reliability, 12 volunteers were each successively interviewed and examined by 6 acupuncturists on the same day. Each acupuncturist gave each volunteer a score for yin and a score for yang on a scale of -10 to +10, zero representing a "balanced" score. Acupuncturists were blinded to each other's scores. RESULTS: Overall mean (+/-standard deviation [SD]) yin and yang scores were -1.86 +/- 0.90 and -0.68 +/- 1.23 respectively. Intraclass correlations (ICCs) associated with a single acupuncturist's ratings were 0.35 (yin) and 0.36 (yang). ICC's for subject's mean scores based on the six acupuncturists were 0.77 (yin) and 0.78 (yang). Significant differences in mean scores across subjects were detected for yin (p < 0.001) and yang (p < 0.001) (repeated-measures analysis of variance [ANOVA]) based on the multiple acupuncturists' ratings. CONCLUSION: These results indicate that (1) yin and yang can be quantified in a reliable manner, but evaluation by multiple acupuncturists is necessary to obtain a reliable score; (2) yin and yang scores can be used to group individuals for the purposes of statistical analysis. Further evaluation of yin and yang scores in a greater number and wider variety of patients will be needed to evaluate the potential usefulness of this measurement tool in acupuncture clinical trials and basic physiologic research.

Massage therapy for patients with metastatic cancer: a pilot randomized controlled trial.

OBJECTIVES: The study objectives were to determine the feasibility and effects of providing therapeutic massage at home for patients with metastatic cancer. DESIGN: This was a randomized controlled trial. SETTINGS/LOCATION: Patients were enrolled at Oncology Clinics at a large urban academic medical center; massage therapy was provided in patients' homes. SUBJECTS: Subjects were patients with metastatic cancer. INTERVENTIONS: There were three interventions: massage therapy, no-touch intervention, and usual care. OUTCOME MEASURES: Primary outcomes were pain, anxiety, and alertness; secondary outcomes were quality of life and sleep. RESULTS: In this study, it was possible to provide interventions for all patients at home by professional massage therapists. The mean number of massage therapy sessions per patient was 2.8. A significant improvement was found in the quality of life of the patients who received massage therapy after 1-week follow-up, which was not observed in either the No Touch control or the Usual Care control groups, but the difference was not sustained at 1 month. There were trends toward improvement in pain and sleep of the patients after therapeutic massage but not in patients in the control groups. There were no serious adverse events related to the interventions. CONCLUSIONS: The study results showed that it is feasible to provide therapeutic massage at home for patients with advanced cancer, and to randomize patients to a no-touch intervention. Providing therapeutic massage improves the quality of life at the end of life for patients and may be associated with further beneficial effects, such as improvement in pain and sleep quality. Larger randomized controlled trials are needed to substantiate these findings.

Characteristics of licensed acupuncturists, chiropractors, massage therapists, and naturopathic physicians.

BACKGROUND: Despite the growing popularity of complementary and alternative medical (CAM) therapies, little is known about the professionals who provide them. Our objective was to describe the characteristics of the four largest groups of licensed CAM providers in the United States and to compare them with the characteristics of conventional physicians. METHODS: Random statewide samples of licensed acupuncturists, chiropractors, massage therapists, and naturopathic physicians living in Arizona, Connecticut, Massachusetts and Washington were interviewed by telephone. Sociodemographic, training, and practice characteristics of CAM providers were elicited and compared with data on conventional physicians published by the American Medical Association. RESULTS: More than 160 providers in each profession were interviewed. Participation rates ranged between 78% and 94% except for Arizona chiropractors (61%). The proportion of female respondents was highest for massage therapy (85%) and acupuncture and naturopathy (almost 60%) and was lowest for chiropractic (about 25%) and conventional medicine (23%). Except for acupuncturists, only 5% of CAM providers were nonwhite. CAM providers were more likely than conventional physicians to practice solo (51%-74% vs 26%, respectively), and less than 10% practiced with medical physicians. Massage therapists saw the fewest patients per week (about 14), and chiropractors and conventional physicians the most (about 100). Chiropractors and conventional physicians saw about 3 patients per hour compared with roughly 1 patient per hour for the other CAM professions. Interstate differences were small. CONCLUSIONS: This characterization of CAM providers will help inform decisions about the future role of CAM providers in the health care system.

Characteristics of visits to licensed acupuncturists, chiropractors, massage therapists, and naturopathic physicians.

BACKGROUND: Despite growing popularity of complementary and alternative medical (CAM) therapies, little is known about the patients seen by CAM practitioners. Our objective was to describe the patients and problems seen by CAM practitioners. METHODS: We collected data on 20 consecutive visits to randomly sampled licensed acupuncturists, chiropractors, massage therapists, and naturopathic physicians practicing in Arizona, Connecticut, Massachusetts, and Washington. Data were collected on patient demographics, smoking status, referral source, reasons for visit, concurrent medical care, payment source, and visit duration. Comparative data for conventional physicians were drawn from the National Ambulatory Medical Care Survey. RESULTS: In each profession, at least 99 practitioners collected data on more than 1,800 visits. More than 80% of visits to CAM providers were by young and middle-aged adults, and roughly two thirds were by women. Children comprised 10% of visits to naturopathic physicians but only 1% to 4% of all visits to other CAM providers. At least two thirds of visits resulted from self-referrals, and only 4% to 12% of visits were from conventional physician referrals. Chiropractors and massage therapists primarily saw musculoskeletal problems, while acupuncturists and naturopathic physicians saw a broader range of conditions. Visits to acupuncturists and massage therapists lasted about 60 minutes compared with 40 minutes for naturopathic physicians and less than 20 minutes for chiropractors. Most visits to chiropractors and naturopathic physicians, but less than one third of visits to acupuncturists and massage therapists, were covered by insurance. CONCLUSIONS: This information will help inform discussions of the roles CAM practitioners will play in the health care system of the future.