Mindfulness-based Intervention for Depressive Symptoms Sent Via Text (MINDSET)
A Daily, Digital Mindfulness-Based Intervention for Depressive Symptoms After Serious Medical Illness
1 other identifier
interventional
76
1 country
1
Brief Summary
The purpose of this study is to develop and test a new intervention to reduce depressive symptoms in post-treatment cancer participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable depression
Started Aug 2026
Typical duration for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2025
CompletedFirst Posted
Study publicly available on registry
February 6, 2025
CompletedStudy Start
First participant enrolled
August 3, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2028
Study Completion
Last participant's last visit for all outcomes
March 31, 2029
January 23, 2026
January 1, 2026
1.7 years
January 31, 2025
January 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Feasibility as assessed by listening rate
80% listening rate of daily audio content
12 weeks
Feasibility as assessed by sample retention rate
80% sample retention
12 weeks
Acceptability rate as assessed by satisfaction rating of daily audio content
(\>8 median satisfaction rating of daily audio content is measured as accepatble
12 weeks
Acceptability rate as assessed by Client Satisfaction Questionnaire (CSQ-8) post-MINDSET
\>24 on the Client Satisfaction Questionnaire (CSQ-8) post-MINDSET will be considered as acceptable. CSQ-8 is a list of questions rating the satisfaction ranging from quite dissatisfied to very satisfied
12 weeks
Secondary Outcomes (2)
Symptoms of depression as measured by PROMIS-D-SF
12 weeks
Symptoms of anxiety as measured by PROMIS-A-SF
12 weeks
Study Arms (2)
ARM 1
EXPERIMENTALParticipants will be randomized to MINDSET
ARM 2
OTHERParticipants will be randomized to EUC
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Self-reported mild to moderately-severe symptoms of depression (score 5-19 on PHQ-9).
- A diagnosis of stage 0-III breast, prostate, or colorectal cancer.
- Completion of primary cancer treatment within 2 years (excludes hormone therapy).
- An ability to provide informed consent.
- An ability to read and speak English.
- Access to a web-enabled device (phone, tablet, computer).
You may not qualify if:
- Self-reported minimal and severe depressive symptoms (\<4 and \> 20 on PHQ-9).
- Self-reported suicidal ideation (\>1 on item 9 PHQ-9).
- Another psychological, medical, or other condition/issue determined that necessitates priority treatment and/or that would interfere with participation (e.g., schizophrenia, borderline personality disorder)
- Current or recent substance abuse/dependence.
- Stage IV cancer diagnosis.
- A cancer recurrence actively requiring treatment.
- Self-reported active mindfulness practice.
- Prior participation in a formal mindfulness program (e.g., MBCT, Mindfulness-Based Stress Reduction Program, Mindfulness-Based Cancer Recovery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Case Comprehensive Cancer Center, Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chelsea Siwik, PhD
Case Comprehensive Cancer Center, Cleveland Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2025
First Posted
February 6, 2025
Study Start (Estimated)
August 3, 2026
Primary Completion (Estimated)
March 31, 2028
Study Completion (Estimated)
March 31, 2029
Last Updated
January 23, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will become available after the completion of the study and the associated publication and will remain available indefinitely.
After the completion of the study and the associated publication, we will deposit de-identified data and metadata (i.e., codebook, focus group interview guides, protocols) that are necessary for or of sufficient quality to validate and replicate the research findings in the Open Science Framework repository (https://osf.io/).