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Clinical Trials/NCT06811454
NCT06811454Not yet recruitingNot Applicable

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

Case Comprehensive Cancer Center1 site in 1 country76 target enrollmentStarted: August 3, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
76
Locations
1
Primary Endpoint
Feasibility as assessed by listening rate

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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).

Exclusion Criteria

  • •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

Arms & Interventions

ARM 1

Experimental

Participants will be randomized to MINDSET

Intervention: MINDSET (Behavioral)

ARM 2

Other

Participants will be randomized to EUC

Intervention: Enhanced Usual Care (EUC) (Behavioral)

Outcomes

Primary Outcomes

Feasibility as assessed by listening rate

Time Frame: 12 weeks

80% listening rate of daily audio content

Feasibility as assessed by sample retention rate

Time Frame: 12 weeks

80% sample retention

Acceptability rate as assessed by satisfaction rating of daily audio content

Time Frame: 12 weeks

(\>8 median satisfaction rating of daily audio content is measured as accepatble

Acceptability rate as assessed by Client Satisfaction Questionnaire (CSQ-8) post-MINDSET

Time Frame: 12 weeks

\>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

Secondary Outcomes

  • Symptoms of depression as measured by PROMIS-D-SF(12 weeks)
  • Symptoms of anxiety as measured by PROMIS-A-SF(12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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