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

A Daily, Digital Mindfulness-Based Intervention for Depressive Symptoms After Serious Medical Illness

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

Study Overview

• Status: Not yet recruiting
• Conditions: Depression; Cancer; Stage I Breast Cancer; Stage II Breast Cancer; Stage I Prostate Cancer; Stage II Prostate Cancer; Stage III Prostate Cancer; Stage III Breast Cancer; Stage III Colorectal Cancer; Stage I Colorectal Cancer; Stage II Colorectal Cancer
• Intervention / Treatment: Behavioral: MINDSET; Behavioral: Enhanced Usual Care (EUC)

Detailed Description

Mindfulness-based interventions (MBIs), including Mindfulness-based Cognitive Therapy (MBCT), reduce depressive symptoms in medically ill populations, including cancer survivors. However, MBIs have limitations, and if improved, could dramatically increase their clinical reach and impact. Most standardized MBIs are group-based, time intensive, difficult to scale, and can be costly. Thus, only a small portion of patients ever engage with MBIs. Digital approaches to delivering mindfulness content (apps and brief MBIs) have shown promise for addressing these barriers to accessibility and scalability. However, these digital approaches are not typically tailored for people with medical illness, like cancer, and/or have poor adherence. Mindfulness app user engagement decreases by 90% within 7 days of download, and the average total use of the app is only 16-21 minutes. Moreover, a recent review of MBIs that included standardized group-based MBIs (e.g., Mindfulness-Based Stress Reduction [MBSR]) and three mindfulness-based apps (e.g., Calm) estimated a 40-60% adherence rate of assigned at-home practice (30-45 minutes/day) in cancer survivors during the MBI, which further declines post-intervention. This suggests that the currently prescribed daily practice dosages are not feasible or accepted by this population. Thus, a brief MBI that optimizes the accessibility and scalability and other benefits of digital and asynchronous delivery, in a feasible and acceptable format, is critically needed for people with depressive symptoms and medical illness.

MBCT, adapted into a brief, daily and digitally delivered format, could increase access, scalability, acceptability, and adherence. While consistent practice for longer sessions yields the most benefit,21 studies have shown improved mood following 5 and 13 minutes of daily meditation for 2 and 8 weeks, respectively. Further, because creating and sustaining a new behavior, like daily meditation, requires consistent repetition, it is plausible that delivering content in short, digestible segments each day, as opposed to longer, weekly sessions, could improve adherence and sustain engagement. The full-length, 8-week MBCT protocol delivered digitally reduces depressive symptoms in cancer survivors, and the standardized 8-week MBCT protocol has already been abbreviated from 2- to 1-hour weekly groups (MBCT-Brief). When tested via remote delivery (telephone), MBCT-Brief showed a decrease in depressive symptoms in participants with medical illness (i.e., hypertension). Because of its abbreviated format and evidence for reducing depressive symptoms in people with medical illness, MBCT-Brief is a logical and feasible intervention to adapt into a daily text-delivered format for depressive symptoms in post-treatment cancer survivors.

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Narissa McCarty, MS; Phone Number: (216) 780-1931; Email: mccartn3@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Case Comprehensive Cancer Center, Cleveland Clinic Foundation
      • Contact: Chelsea Siwik, PhD
      • Principal Investigator: Chelsea Siwik, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Self-reported mild to moderately-severe symptoms of depression (score 5-19 on PHQ-9).
2. A diagnosis of stage 0-III breast, prostate, or colorectal cancer.
3. Completion of primary cancer treatment within 2 years (excludes hormone therapy).
4. An ability to provide informed consent.
5. An ability to read and speak English.
6. Access to a web-enabled device (phone, tablet, computer).

Exclusion Criteria:

1. Self-reported minimal and severe depressive symptoms (<4 and > 20 on PHQ-9).
2. Self-reported suicidal ideation (>1 on item 9 PHQ-9).
3. 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)
4. Current or recent substance abuse/dependence.
5. Stage IV cancer diagnosis.
6. A cancer recurrence actively requiring treatment.
7. Self-reported active mindfulness practice.
8. Prior participation in a formal mindfulness program (e.g., MBCT, Mindfulness-Based Stress Reduction Program, Mindfulness-Based Cancer Recovery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARM 1; Participants will be randomized to MINDSET	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.
Other: ARM 2; Participants will be randomized to EUC	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms of depression as measured by PROMIS-D-SF	The PROMIS-D-SF is an 8-question survey that measures depression on a scale from 1 (never) to 5 (always).	12 weeks
Symptoms of anxiety as measured by PROMIS-A-SF	The PROMIS-A-SF is an 8-question survey that measures anxiety on a scale from 1 (never) to 5 (always).	12 weeks

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Chelsea Siwik, PhD, Case Comprehensive Cancer Center, Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): August 3, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2029

Study Registration Dates

• First Submitted: January 31, 2025
• First Submitted That Met QC Criteria: January 31, 2025
• First Posted (Actual): February 6, 2025

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Post treatment Depression
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Intestinal Diseases; Behavioral Symptoms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Skin Diseases; Breast Diseases; Behavior; Skin and Connective Tissue Diseases; Neoplasms; Prostatic Neoplasms; Colorectal Neoplasms; Depression; Breast Neoplasms; Stress Mindset Measure
• Other Study ID Numbers: CASE1Y24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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/).
• IPD Sharing Time Frame: Data will become available after the completion of the study and the associated publication and will remain available indefinitely.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No