Mindfulness-based Intervention for Depressive Symptoms Sent Via Text (MINDSET)

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT06811454
Status
Not Yet Recruiting

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Conditions

  • Cancer
  • Depression
  • Stage I Breast Cancer
  • Stage I Colorectal Cancer
  • Stage I Prostate Cancer
  • Stage II Breast Cancer
  • Stage II Colorectal Cancer
  • Stage II Prostate Cancer
  • Stage III Breast Cancer
  • Stage III Colorectal Cancer
  • Stage III Prostate Cancer

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • MINDSET — BEHAVIORAL
    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.
  • Enhanced Usual Care (EUC) — BEHAVIORAL
    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.

Study Details

The purpose of this study is to develop and test a new intervention to reduce depressive symptoms in post-treatment cancer participants.

Key Dates

Start date
Aug 3, 2026
Status verified
Jan 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
76 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: ARM 1
    Participants will be randomized to MINDSET
  • Other: ARM 2
    Participants will be randomized to EUC

Primary Outcome Measure

Feasibility as assessed by listening rate [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Case Comprehensive Cancer Center, Cleveland Clinic FoundationClevelandOhio44195
Chelsea Siwik, PhD
Chelsea Siwik, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Cleveland, OH

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Case Comprehensive Cancer Center, Cleveland Clinic Foundation· Cleveland, OH

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