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. 2020 Jul 23;21:670. doi: 10.1186/s13063-020-04530-9

Table 2.

Incorporation of TRTT counseling protocol into the NIH Behavior Change Consortium model [1] of treatment fidelity

Goal TRTT strategies
Design
 Ensure same treatment dose within different settings Development of a standard protocol for counseling to administer at military hospitals across the country by audiologists with differences in previous experience in treating patients with tinnitus.
 Ensure equivalent dose across conditions Counseling conducted at treatment visits conducted within 2 months following randomization and a follow-up treatment visit 1 month later.
 Plan for implementation setbacks Standard certification requirements for replacement of study audiologists during the trial.
Training providers
 Standardize training Completion of training by reading relevant sections of the TRTT Manual of Procedures and (1) attendance at a two-day regional training session, (2) attendance at a webinar, or (3) viewing a videotape of a counseling session.
 Ensure provider skill acquisition Competency assessed through submission of a “dummy” audiotape of each type of counseling session for review by the protocol monitors
 Minimize “drift” in provider skills Submission of randomly selected audiotapes during the trial for review by protocol monitors.
 Accommodate provider differences Scripts with suggested wording for both types of counseling, but with allowances for individual styles.
Monitoring and improving delivery of treatment
 Control for provider differences Checklists used to ensure adherence to critical components.
 Reduce difference within treatment Separate scripts and visual aids to be used during counseling sessions including an instructive flip chart and 3-D ear models.
 Ensure adherence to treatment protocol Submission of audiotapes and checklists of first two of each type of counseling session for review by protocol monitors; submission of randomly selected audiotapes and checklists after sessions initially reviewed.
 Minimize contamination between conditions Separate checklists and scripts for each type of counseling session.
Improving receipt of treatment
 Ensure participant comprehension Interactive sessions with opportunity for questioning both by participant and family.
 Ensure participant ability to use cognitive skills Handouts that summarized concepts covered during counseling that participants could take home.
 Ensure participant ability to perform behavioral skills Practice during the counseling session and handouts that included symptom management strategies to be practiced following the session.
Enactment of treatment skills
 Ensure participant use of cognitive and behavioral skills Assessment of impact of tinnitus through administration of tinnitus-specific health-related quality of life instruments