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

Case Comprehensive Cancer Center (Case CCC)

Status: Begins enrollment in 5 months

Conditions: Stage II Colorectal Cancer; Stage III Colorectal Cancer; Stage II Prostate Cancer; Stage I Colorectal Cancer; Stage II Breast Cancer; Stage I Breast Cancer; Stage I Prostate Cancer; Stage III Breast Cancer; Cancer; Depression; Stage III Prostate Cancer

Treatments: Behavioral: Enhanced Usual Care (EUC); Behavioral: MINDSET

Study type: Interventional

Funder types: Other

Identifiers

NCT06811454

CASE1Y24

Details and patient eligibility

About

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

Full 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.

Enrollment: 76 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

ARM 1

Experimental group

Description:

Participants will be randomized to MINDSET

Treatment:

Behavioral: MINDSET

ARM 2

Other group

Description:

Participants will be randomized to EUC

Treatment:

Behavioral: Enhanced Usual Care (EUC)