Objectives Following the British Medical Research Council recommendations for pilot trials, this study aims to increase experience with a complex integrative medicine (IM) intervention in a randomized controlled design to assess the feasibility for studying this intervention in a larger trial. Specific objectives are to: 1) assess the feasibility of implementing this IM approach to improve dysfunction from tinnitus in a large clinical trial; 2) evaluate patient satisfaction with this complex intervention; and 3) obtain preliminary clinical efficacy data using the planned procedures and measures. Design & methods This NIDCD-funded pilot study targets retention of 40 participants with significant tinnitus-related dysfunction, recruited from a conventional otolaryngology clinic. To maximize experience with the intervention, enrolled participants are randomized in a 3:1 ratio to IM + a commonly applied sound-based and educational therapy (SBE) or to SBE alone. The 6-month IM treatment includes the same SBE, modeled after the Veteran’s Affairs Progressive Tinnitus Management approach, as well as 3 cognitive behavioral psychotherapy sessions, an 8-week Mindfulness Based Stress Reduction course, 5 acupuncture sessions, and 9 telephonic health coaching sessions. Enrollment, retention, patient satisfaction and lessons learned by the trial team will determine the feasibility of using this complex IM intervention in a large trial. Baseline, post-treatment, and 3-months follow-up measures and trial procedures planned for the larger trial are also piloted, with change in tinnitus-dysfunction over the intervention slated to provide preliminary clinical efficacy data. Discussion This pilot protocol will inform decisions regarding the feasibility of using this complex IM intervention in a large clinical trial. The larger trial would potentially offer patients an IM treatment to amplify conventional SBE for those who are unable to habituate to tinnitus.
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