Randomised controlled trial of interventions for bothersome tinnitus: DesyncraTM versus cognitive behavioural therapy.

OBJECTIVE: Compare the relative efficacy of DesyncraTM and Cognitive Behavioural Therapy (CBT). DESIGN AND STUDY SAMPLE: Sixty-one participants were randomly assigned to receive either DesyncraTM (n = 29) or CBT (n = 32). Randomisation included stratification regarding current hearing aid (HA) use. Depending on group assignment, participants attended approximately 7-12 visits. Tinnitus distress was measured using the Tinnitus Questionnaire (TQ). RESULTS: Mean TQ scores decreased post-baseline from 5-15 points across treatment arms and strata. Model-based findings for the no-HA stratum showed a difference of -2.0 TQ points favouring Desyncra at 24-weeks, with a 90% posterior interval varying from -5.4 points favouring Desyncra to 0.8 TQ points favouring CBT. For the HA stratum, results show a difference of -1.0 TQ points favouring Desyncra, with a 90% posterior interval ranging from -4.7 points favouring Desyncra to 2.9 points favouring CBT. CONCLUSIONS: The difference between Desyncra and CBT on average showed greater improvement with Desyncra in the no-HA stratum by about 2 TQ points. To the extent that the study sample represents a clinical population and recognising the assumptions in the design and analysis, these results suggest Desyncra is just as effective or more so than CBT in reducing tinnitus distress.

Trauma disclosure to health care professionals by veterans: clinical implications.

Trauma disclosure is the initial step toward healing trauma-related distress. This study used qualitative methods to better understand factors facilitating and inhibiting change in the disclosure process. Fifty-six veterans were interviewed about their disclosure experiences between August 2004 and 2005. Emerging themes and barriers to disclosure from 23 of these interviews are reported in this article. Barriers to trauma disclosure included lack of trust in the provider, fears about the potential negative consequences of disclosure, and trauma avoidance. Providers perceived as caring and communicating at the same level as the participants facilitated disclosure, whereas providers perceived as uncaring or disinterested inhibited disclosure. Veterans reported both positive and negative reactions to initial disclosure, but nearly all agreed that disclosure was worthwhile over the long-term. Improving patient-provider communications and creating settings that facilitate trauma disclosure may improve healing after trauma.

Collaborative care for chronic pain in primary care: a cluster randomized trial.

CONTEXT: Chronic pain is common in primary care patients and is associated with distress, disability, and increased health care use. OBJECTIVE: To assess whether a collaborative intervention can improve chronic pain-related outcomes, including comorbid depression severity, in a Department of Veterans Affairs primary care setting. DESIGN, SETTING, AND PARTICIPANTS: Cluster randomized controlled trial of a collaborative care assistance with pain treatment intervention vs treatment as usual at 5 primary care clinics of 1 Department of Veterans Affairs Medical Center. Forty-two primary care clinicians were randomized to the assistance with pain treatment intervention group or the treatment as usual group. The 401 patients had musculoskeletal pain diagnoses, moderate or greater pain intensity, and disability lasting 12 weeks or longer and were assigned to the same treatment groups as their clinicians. Recruitment occurred from January 2006 to January 2007 and follow-up concluded in January 2008. INTERVENTION: Assistance with pain treatment included a 2-session clinician education program, patient assessment, education and activation, symptom monitoring, feedback and recommendations to clinicians, and facilitation of specialty care. MAIN OUTCOME MEASURES: Changes over 12 months in pain-related disability (Roland-Morris Disability Questionnaire, range of 0-24), pain intensity (Chronic Pain Grade [CPG] Pain Intensity subscale, range of 0-100), and depression (Patient Health Questionnaire 9 [PHQ-9], range of 0-27), measured as beta coefficients (difference in slopes in points per month). RESULTS: Intervention patients had a mean (SD) of 10.6 (4.5) contacts with the assistance with pain treatment team. Compared with the patients receiving treatment as usual, intervention patients showed greater improvements in pain-related disability (Roland-Morris Disability Questionnaire beta, -0.101 [95% confidence interval {CI}, -0.163 to -0.040]; P = .004 and CPG Pain Intensity subscale beta, -0.270 [95% CI, -0.480 to -0.061]; P = .01). Among patients with baseline depression (PHQ-9 score > or = 10), there was greater improvement in depression severity in patients receiving the intervention compared with patients receiving treatment as usual (PHQ-9 beta, -0.177 [95% CI, -0.295 to -0.060]; P = .003). The differences in scores between baseline and 12 months for the assistance with pain treatment intervention group and the treatment as usual group, respectively, were -1.4 vs -0.2 for the Roland-Morris Disability Questionnaire, -4.7 vs -0.6 for the CPG Pain Intensity subscale, and -3.7 vs -1.2 for PHQ-9. CONCLUSION: The assistance with pain treatment collaborative intervention resulted in modest but statistically significant improvement in a variety of outcome measures. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00129480.

Rationale, design, and baseline findings from a randomized trial of collaborative care for chronic musculoskeletal pain in primary care.

OBJECTIVE: This article describes the rationale, design, and baseline findings from an ongoing study of collaborative care for chronic musculoskeletal pain and comorbid depression. DESIGN: Cluster randomized clinical trial. PARTICIPANTS AND SETTING: Forty-two clinicians and 401 patients from five Veterans Affairs primary care clinics. INTERVENTION: The intervention was based on the chronic care model, and included patient and provider activation and education, patient assessment, outcomes monitoring, and feedback to providers over 12 months. The intervention team consisted of a full-time psychologist care manager and a part-time physician internist. Approaches included goal setting emphasizing function, patient activation and educating about fear avoidance, and care management. OUTCOME MEASURES: Main outcomes are Roland-Morris Disability Questionnaire (RMDQ) score, depression severity (Patient Health Questionnaire-9), and pain severity (Chronic Pain Grade Severity subscale) at 6 and 12 months. BASELINE RESULTS: Fifteen percent of primary care patients mailed a study advertisement letter requested screening for the study. The mean age of enrolled patients was 62. Back and neck or joint pain diagnoses were present in 67% and 65% of patients, respectively. Mean pain duration was 15 years, and mean RMDQ score (range 0-24) was 14.7 (standard deviation = 4.4). Sixty-five percent of patients were receiving disability. Eighteen percent of patients met criteria for major depression, 17% for posttraumatic stress disorder, and 9% for alcohol misuse. Thirty-nine percent of patients felt strongly that experiencing pain was a sign of damage, and 60% reported strong avoidance of painful activities. CONCLUSIONS: These baseline data support the rationale to develop a multifaceted approach to treat chronic pain in primary care that includes detection and treatment of psychiatric comorbidity.

Veterans' disclosure of trauma to healthcare providers.

OBJECTIVE: The purpose of this study is to gain a better understanding of patients' trauma disclosure to health professionals. METHOD: A convenience sample of 173 veterans in outpatient treatment for posttraumatic stress disorder (PTSD) in the Veterans Health Administration completed surveys querying trauma history, reasons for trauma disclosure and perceived provider responses. RESULTS: For half of the participants, a healthcare provider was the first person to whom they disclosed. Reasons were primarily external, such as pressure from others. Although 72% were glad to disclose, 45% perceived at least one negative provider response. CONCLUSION: Patients disclose to a wide range of provider types and perceive varied responses. Providers' awareness of the need to be sensitive to trauma disclosure could facilitate treatment for PTSD.

Primary care provider preferences for working with a collaborative support team.

BACKGROUND: Clinical interventions based on collaborative models require effective communication between primary care providers (PCPs) and collaborative support teams. Despite growing interest in collaborative care, we have identified no published studies describing how PCPs prefer to communicate and interact with collaborative support teams. This manuscript examines the communication and interaction preferences of PCPs participating in an ongoing randomized clinical trial of a collaborative intervention for chronic pain and depression. METHODS: The trial is being conducted in five primary care clinics of a Veterans Affairs Medical Center. Twenty-one PCPs randomized to the study intervention completed a survey regarding preferences for interacting with the collaborative support team. RESULTS: A majority of PCPs identified email (95%) and telephone calls (68%) as preferred modes for communicating with members of the support team. In contrast, only 29% identified in-person communications as preferred. Most PCPs preferred that the care manager and physician pain specialist assess patients (76%) and make initial treatment changes (71%) without first conferring with the PCP. One-half wanted to be designated cosigners of all support team notes in the electronic medical record, one-half wanted to receive brief and focused information rather than in-depth information about their patients, and one-half wanted their practice nurses automatically included in communications. Panel size was strongly associated (p < 0.001) with preference for brief, to-the-point discussions about patients. CONCLUSION: The substantial variation in PCP communication preferences suggests the need for knowledge of these preferences when designing and implementing collaborative interventions. Additional research is needed to understand relationships between clinician and practice characteristics and interaction preferences.

How does coping help people resist lapses during smoking cessation?

OBJECTIVES: To determine whether types of coping strategies have differential effects on preventing lapses and lowering urge levels and to investigate mechanisms by which coping strategies prevent lapses during smoking cessation. DESIGN: Sixty-one respondents performed ecological momentary assessment using palm-top computers and tape recorders to report their coping strategies and urge levels before and after temptations to smoke. Multilevel linear regression models were used to compare the effects of individual strategy types with the average strategy. MAIN OUTCOME MEASURES: Lapses versus resisted temptations and changes in urge levels. RESULTS: Number of strategies significantly predicted resisting smoking and change in urge levels. Compared with the effect of the average strategy, movement/exercise was marginally worse at preventing lapses, and food/drink was marginally related to higher postcoping urge levels. CONCLUSION: Although using multiple coping strategies helps people resist the urge to smoke, no particular coping strategy works better than any other. Coping strategies prevent lapses by reducing high urge levels during temptations.

Clinical Global Impression of Change in Physical Frailty: development of a measure based on clinical judgment.

OBJECTIVES: To expand the ability to assess physical frailty by developing a Clinical Global Impression of Change in Physical Frailty (CGIC-PF) instrument. DESIGN: Qualitative and quantitative instrument development. SETTING: Academic centers. PARTICIPANT: s Six expert panel members, 46 clinicians, 24 patients, and 12 caregivers. MEASUREMENTS: Literature review and structured group processes with experts, clinicians, and consumers were used to generate an initial list of domains and indicators. Structured interviews with clinical experts in the area of frailty were used to establish relevance and feasibility of measurement of domains. Interrater reliability was assessed through a Web-based study. Geriatricians pilot tested the feasibility of the baseline CGIC-PF with 10 patients. RESULTS: The CGIC-PF includes six intrinsic domains (mobility, balance, strength, endurance, nutrition, and neuromotor performance) and seven consequences domains (medical complexity, healthcare utilization, appearance, self-perceived health, activities of daily living, emotional status, and social status). Each domain has two to four clinical indicators. Change is scored on a 7-point scale from markedly worse to markedly improved. Average interrater reliability of the CGIC-PF for the Web-based cases was 0.97. Geriatricians completed a baseline CGIC-PF on their own patients in 10 minutes or less. CONCLUSION: The CGIC-PF is a structured assessment of change in physical frailty with defined content and process. It has strong face validity, reliability, and feasibility for use in clinical research. It may be useful as one criterion of change and as an anchor for change in other measures.