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Table 2 Incorporation of TRTT counseling protocol into the NIH Behavior Change Consortium model [1] of treatment fidelity

From: Treatment fidelity in the Tinnitus Retraining Therapy Trial

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