DepressionNCT06811454
Mindfulness-based Intervention for Depressive Symptoms Sent Via Text (MINDSET)
A study testing MINDSET in people with Depression and Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to develop and test a new intervention to reduce depressive symptoms in post-treatment cancer participants. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Depression, Cancer, Stage III Breast Cancer
- What is being tested?
- MINDSET
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2026to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Case Comprehensive Cancer Center, Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Chelsea Siwik, PhD
Chelsea Siwik, PhD
About this study
Official title: 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.
Read the 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
- Being tested
- MINDSET, Enhanced Usual Care (EUC)
- Keywords
- Post treatment Depression
- Medical subject headings
- Depression, Neoplasms, Breast Neoplasms, Prostatic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MINDSETBehavioural
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.
Enhanced Usual Care (EUC)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ARM 1 | Experimental | Participants will be randomized to MINDSET Receives: Behavioral: MINDSET |
| ARM 2 | Other | Participants will be randomized to EUC Receives: Behavioral: Enhanced Usual Care (EUC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as assessed by listening rate
80% listening rate of daily audio content
Measured: 12 weeks
Feasibility as assessed by sample retention rate
80% sample retention
Measured: 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
Measured: 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
Measured: 12 weeks
Secondary outcomes (2)
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).
Measured: 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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start3 Aug 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chelsea Siwik, PhD, Principal investigator, Case Comprehensive Cancer Center, Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811454
- Sponsor's protocol ID
- CASE1Y24
- Status last verified
- Jan 2026
- First submitted
- 31 Jan 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/).
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Daily, Digital Mindfulness-Based Intervention for Depressive Symptoms After Serious Medical Illness
- ClinicalTrials.gov ID
- NCT06811454
- Acronym / sponsor ID
- CASE1Y24
- Conditions
- Depression, Cancer, Stage III Breast Cancer, Stage II Breast Cancer, Stage I Breast Cancer, Stage III Prostate Cancer
- Keywords
- Post treatment Depression
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 3 Aug 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM 1 | Experimental | Behavioral: MINDSETParticipants will be randomized to MINDSET |
| ARM 2 | Other | Behavioral: Enhanced Usual Care (EUC)Participants will be randomized to EUC |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MINDSETParticipants 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. | Behavioural | ARM 1 |
| 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. | Behavioural | ARM 2 |
Primary outcome
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
2 secondary outcomes
Symptoms of depression as measured by PROMIS-D-SF
Time frame: 12 weeks
Symptoms of anxiety as measured by PROMIS-A-SF
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: Yes. 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/).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chelsea Siwik, PhD principal investigator
Case Comprehensive Cancer Center, Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MINDSET in people with Depression and Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Narissa McCarty, MS ((216) 780-1931, mccartn3@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as assessed by listening rate (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.