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

NCT ID: NCT06811454

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-08-03
• Study Completion Date: 2029-03-31

Brief Summary

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

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

ARM 1

Participants will be randomized to MINDSET

Group Type: EXPERIMENTAL

MINDSET

Intervention Type: 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.

ARM 2

Participants will be randomized to EUC

Group Type: OTHER

Enhanced Usual Care (EUC)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chelsea Siwik, PhD

Role: PRINCIPAL_INVESTIGATOR

Case Comprehensive Cancer Center, Cleveland Clinic

Locations

Case Comprehensive Cancer Center, Cleveland Clinic Foundation

Cleveland, Ohio, United States

Countries

United States

Central Contacts

Narissa McCarty, MS

Role: CONTACT

mccartn3@ccf.org

(216) 780-1931

Facility Contacts

Chelsea Siwik, PhD

Role: primary

Other Identifiers

CASE1Y24

Identifier Type: -

Identifier Source: org_study_id