Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-24 @ 10:31 PM
Ignite Modification Date: 2025-12-24 @ 10:31 PM
NCT ID: NCT03555435
Brief Summary: Many Veterans with mental health care needs go without care due to stigma, practical problems with getting services, and a high value on self-sufficiency. VHA has developed online programs aimed at fostering MH that are easy to access and may be more acceptable than psychotherapy. The purpose of this study is to learn whether peer-supported use of an online problem-solving course is acceptable and helpful and whether the study data can be collected online. Results of this pilot study would inform a larger study of the impact on problem-solving and mental health of a non-stigmatizing, online program - with and without peer support. If effective, peer supported online programs would improve the quality of care to Veterans with unmet mental health needs.
Detailed Description: Approval will be obtained from VA primary care staff leaders at Palo Alto Division and VA Palo Alto Community Based Outpatient Clinics (CBOCs) to mail notes and a study information card to patients who do not have stop codes for mental health or integrated care in their EMR records for the past six months. The study information cards will describe the study, how to enroll, and will direct the Veteran to REDCap eligibility screening questions. When eligibility is confirmed, REDCap will automatically alert research assistant to enroll participant and randomize. Primary Care Mental Health Integration staff at each clinic may also refer patients to the study by entering referral information directly into secure, encrypted REDCap files or by handing the patient a study information card. Community veterans will be invited via social media marketing. Ads will link to a study web site. Study web site will link potential participants to REDCap eligibility screening questions. When eligibility is confirmed, REDCap will automatically alert research assistant to enroll participant and randomize. Veterans who decide to be in the study will be assigned by chance to one of three groups: An On Your Own group, a Peer Support group, or a Wait group. Veterans assigned to take the Moving Forward course with peer support or on their own will complete the course online and practice the problem-solving skills they learned for six weeks. Finishing the Moving Forward course takes a total of about four hours. Veterans in the peer support group will speak with a Veteran who is experienced with the course on the phone for 15 to 20 minutes once a week during the study about using the ideas and exercises in the course to solve problems. Veterans assigned to the wait group will answer questions online about problem-solving skills and their well-being at the start and after six weeks). They will be able to take the course if they would like to after the six weeks have passed. Veterans in the On Your Own and Peer Support groups will answer questions online at the beginning, middle, and end of the study about problem-solving skills, their opinions about the course and about peer support (if they got it), and their well-being. This will take 10 to 15 minutes each time.
Study: NCT03555435
Study Brief:
Protocol Section: NCT03555435