Clinical trial · Interventional
Mindfulness-based Intervention for Depressive Symptoms Sent Via Text (MINDSET)
A Daily, Digital Mindfulness-Based Intervention for Depressive Symptoms After Serious Medical Illness
NCT06811454CI-TRIAL-00101474not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to develop and test a new intervention to reduce depressive symptoms in post-treatment cancer participants.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Depression | — | UNRESOLVED | — |
| Stage I Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Stage II Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Stage III Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Stage III Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enhanced Usual Care (EUC) | Behavioral | — | UNRESOLVED |
| MINDSET | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ARM 1
- description
- Participants will be randomized to MINDSET
- interventionNames
- Behavioral: MINDSET
- type
- OTHER
- label
- ARM 2
- description
- Participants will be randomized to EUC
- interventionNames
- Behavioral: Enhanced Usual Care (EUC)
Primary outcomes (4)
- measure
- Feasibility as assessed by listening rate
- timeFrame
- 12 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.