Mindfulness-based Intervention for Depressive Symptoms Sent Via Text (MINDSET)
NCT06811454 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76
Last updated 2026-01-23
Summary
The purpose of this study is to develop and test a new intervention to reduce depressive symptoms in post-treatment cancer participants.
Conditions
- Depression
- Cancer
- Stage III Breast Cancer
- Stage II Breast Cancer
- Stage I Breast Cancer
- Stage III Prostate Cancer
- Stage II Prostate Cancer
- Stage I Prostate Cancer
- Stage III Colorectal Cancer
- Stage II Colorectal Cancer
- Stage I Colorectal Cancer
Interventions
- BEHAVIORAL
-
MINDSET
Participants randomized to MINDSET will receive a text message at their preferred time each day for 8 weeks containing a link to the 15-minute audio content. At the end of each week (on day 7), participants will receive a second link to the weekly survey in the text. Participants will be able to play the audio content on their device by clicking the first link and access the weekly survey by clicking the second.
- BEHAVIORAL
-
Enhanced Usual Care (EUC)
Participants will receive a 1-page brochure summarizing publicly available information on depression self-care strategies via text each week for 8 weeks on the same day they receive the text message containing a link to the weekly survey (day 7). This information will come from the Facing Forward: Life After Cancer Treatment booklet from the National Cancer Institute.38 Weekly topics will include: 1) Reducing stress; 2) Coping with stress; 3) Coping with depression; 4) Feeling angry; 5) Feeling alone; 6) Finding meaning after treatment; 7) Social relationships; and 8) Seeking support. These materials do not include any content on mindfulness or cognitive therapy.
Sponsors & Collaborators
-
Case Comprehensive Cancer Center
lead OTHER
Principal Investigators
-
Chelsea Siwik, PhD · Case Comprehensive Cancer Center, Cleveland Clinic
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-03
- Primary Completion
- 2028-03-31
- Completion
- 2029-03-31
Countries
- United States
Study Locations
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