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Table 4 Participant recruitment

From: The Appalachia Mind Health Initiative (AMHI): a pragmatic randomized clinical trial of adjunctive internet-based cognitive behavior therapy for treating major depressive disorder among primary care patients

I. Clinic pre-recruitment

 A. The primary care physician will determine patient eligibility during the clinical appointment and provide the potential participant with a study fact brochure that describes the study and provides an 800 number for questions. Physicians will share the name and phone number of eligible patients with study staff based on patient permission.

 B. Participating clinical facilities will look through charts daily to identify those patients that met inclusion criteria but were not informed of the study by their provider. A cover letter about the study will then be mailed to these patients under the signature of the provider along with the study fact brochure.

II. Telephone recruitment

 A. Patients who do not opt out in Phase 1 A will receive a telephone call within 24 h from the study staff.

 B. Patients who are identified in Phase 1 B will be provided in the letter with an opt-out number to call if they do not want to be contacted by study staff. Staff will attempt to contact patients that do not call to opt out within 72 h.

 C. Once study staff make telephone contact with the participant on the phone:

  1. Study staff will assess eligibility, review the content of the study fact brochure, and answer questions.

  2. Study staff will seek verbal informed consent and contact information including email address and preference for email versus text.

  3. If a participant prefers to physically sign the informed consent script, two hard copies will be mailed to the participant with a pre-stamped pre-addressed return envelope with instruction to keep one copy and mail back the second signed copy.