Mental Health IssueNCT07160439
Evaluating Digital Micro-Interventions to Reduce Distress and Increase Wellbeing in Breast Cancer Survivors
A study testing Digital Micro-Interventions in people with Mental Health Issue and Breast Cancer, run by University of Virginia at 1 site in United States.
Trial summary
Digital mental and behavioral health interventions have potential to significantly improve accessibility for the large number of breast cancer survivors who need treatments. However, the landscape of digital interventions tested in this population remains limited, with the few that have been tested primarily focused… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mental Health Issue, Breast Cancer
- What is being tested?
- Digital Micro-Interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age = 18 years.
- 0-5 years post-diagnosis of Stage I, II, or III female breast cancer.
- Elevated symptoms of depression and/or anxiety as measured by the PHQ-8 (score > 9) or GAD-7 (score > 7).
Who cannot join
- Receiving individual (1 on 1) treatment for depression and/or anxiety to avoid treatment interference (note, individuals will be permitted to enroll if they are taking antidepressant medication and have not had an appointment to adjust the dosage over the past 2 weeks)
- Active suicidal ideation during the enrollment/screening call based on a trained staff member orally administering the suicidality item from the PHQ-9 to individuals on the phone ("In the last 2 weeks, have you had thoughts that you would be better off dead, or thoughts of hurting yourself in some way?"). If an individual responds in any way other than "not at all" based on the available response options (i.e., either "several days", "more than half the days", or "nearly every day"), or if they mention having suicidal ideation or thoughts of death during the enrollment/screening call, the Pitt-Optimum risk assessment tool will be administered. Only participants deemed low risk may proceed in enrollment; all will be given additional resources.
- Do not have an app-compatible phone (i.e., iOS 10.3 or later or Android 4.0.3 or later).
- Cannot read and speak English (interventions only available in English).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22904
About this study
Digital mental and behavioral health interventions have potential to significantly improve accessibility for the large number of breast cancer survivors who need treatments. However, the landscape of digital interventions tested in this population remains limited, with the few that have been tested primarily focused on reducing symptoms of mental disorders. This is problematic given the range of psychosocial needs among breast cancer survivors, including those who may not have active mental health symptoms, yet could benefit from learning effective coping skills. Moreover, all of these interventions follow a "one size fits all" approach, lacking precision in terms of when, where, and to whom they should be given. The overarching goals of this project are to develop and pilot a variety of digital micro-interventions (DMIs) for breast cancer survivors - highly focused, technology-enabled interventions that can be delivered in the context of a person's daily life with little burden on the individual.
- Conditions
- Mental Health Issue, Breast Cancer
- Being tested
- Digital Micro-Interventions
- Keywords
- Depression, Anxiety, Well-Being
- Medical subject headings
- Breast Neoplasms, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Micro-InterventionsBehavioural
Digital Micro-Interventions are brief interventions that target specific behavioral and cognitive mechanisms of mental health, designed for brief periods of engagement.
| Study group | Role | What they receive |
|---|---|---|
| Savoring | Experimental | Participants are asked to think of a positive and personally meaningful memory to meditate on. They are led through steps to enter their memory, which is then summarized and turned into a meditation practice. Receives: Behavioral: Digital Micro-Interventions |
| Gratitude | Experimental | Participants are asked to generate a list of things they are grateful for. They are led through an automated process of selecting a source of gratitude and reflecting on it. Receives: Behavioral: Digital Micro-Interventions |
| Challenging UnhelpfulThoughts | Experimental | Participants are taught how to identify unhelpful thoughts, challenge them, and generate more balanced, helpful thoughts through an automated process that leads them step-by-step. Receives: Behavioral: Digital Micro-Interventions |
| Psychoeducation | Experimental | Participants receive access to psychoeducation content on mental health, distress, and well-being. They are provided tidbits of information every day to learn from. Receives: Behavioral: Digital Micro-Interventions |
| Behavioral Activation | Experimental | Participants are led through an automated process of identifying tasks they can accomplish in their daily lives. Receives: Behavioral: Digital Micro-Interventions |
| Acceptance | Experimental | Participants are led through an automated process of accepting, rather than actively trying to push away, their distressing emotions or thoughts. Receives: Behavioral: Digital Micro-Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Digital Micro-Intervention
12 item scale measuring satisfaction and acceptability. Each question is scored on a 0-4 scale with a total raw summed score range of 0-48. Higher scores indicate greater satisfaction and acceptability. Note, this measure could only be administered at post because it requires that participants used the intervention they were assigned, which was provided after they completed the baseline questionnaire battery.
Measured: Post 1 week
Secondary outcomes (12)
PROMIS-29 Profile
24 items that measure various physical and mental health subdomains. Each question is scored on a 1-5 scale. The total raw score for Mental Health is composed of the 2 subdomains of Anxiety and Depression range from 8-40, where higher scores indicate worse overall mental health. The total raw score for Physical Health is composed of the 4 subdomains of Physical Function, Fatigue, Sleep Disturbance, and Ability to Participate in Social Activities, range from 16-80, where higher scores indicate worse overall physical health. The 4-item Pain Interference subscale and an item that assesses pain from 1-10 were omitted from the original PROMIS-29 Profile to limit redundancy with another pain measure.
Measured: Baseline
PROMIS-29 Profile
24 items that measure various physical and mental health subdomains. Each question is scored on a 1-5 scale. The total raw score for Mental Health is composed of the 2 subdomains of Anxiety and Depression range from 8-40, where higher scores indicate worse overall mental health. The total raw score for Physical Health is composed of the 4 subdomains of Physical Function, Fatigue, Sleep Disturbance, and Ability to Participate in Social Activities, range from 16-80, where higher scores indicate worse overall physical health. The 4-item Pain Interference subscale and an item that assesses pain from 1-10 were omitted from the original PROMIS-29 Profile to limit redundancy with another pain measure.
Measured: Post 1 week
Pain, Enjoyment of Life and General Activity (PEG) Scale
Assesses chronic pain based on 3 items, each one ranging from 0-10. Scores range from 0-30, with higher scores indicating more pain severity and interference.
Measured: Baseline
Pain, Enjoyment of Life and General Activity (PEG) Scale
Assesses chronic pain based on 3 items, each one ranging from 0-10. Scores range from 0-30, with higher scores indicating more pain severity and interference.
Measured: Post 1 week
Emotion Regulation Questionnaire
A 10 item scale to reassess for two emotion regulation strategies: cognitive reappraisal and expressive suppression. Participants rate each item on a 7-point Likert scale, ranging from 1 (strongly disagree) to 7 (strongly agree). Scores for each subscale range from 1-7 (after dividing by the number of items), with higher scores indicating a greater tendency to use that particular emotion regulation strategy.
Measured: Baseline
Emotion Regulation Questionnaire
A 10 item scale to reassess for two emotion regulation strategies: cognitive reappraisal and expressive suppression. Participants rate each item on a 7-point Likert scale, ranging from 1 (strongly disagree) to 7 (strongly agree). Scores for each subscale range from 1-7 (after dividing by the number of items), with higher scores indicating a greater tendency to use that particular emotion regulation strategy.
Measured: Post 1 week
Insomnia Severity Index
A 7-item measure to evaluate severity of insomnia symptoms. Each item is evaluated on a scale from 0-4. Scores range from 0-28, with higher scores indicating greater severity of insomnia symptoms.
Measured: Baseline
Insomnia Severity Index
A 7-item measure to evaluate severity of insomnia symptoms. Each item is evaluated on a scale from 0-4. Scores range from 0-28, with higher scores indicating greater severity of insomnia symptoms.
Measured: Post 1 week
Patient Health Questionnaire-8
8 item scale that measures depression symptoms on a continuous scale. Scores range from 0-24, with a higher score indicating greater severity of symptoms of depression.
Measured: Baseline
Patient Health Questionnaire-8
8 item scale that measures depression symptoms on a continuous scale. Scores range from 0-24, with a higher score indicating greater severity of symptoms of depression.
Measured: Post 1 week
Generalized Anxiety Disorder-7
7 item scale that measures anxiety symptoms on a continuous scale. Scores range from 0-21, with a higher score indicating greater severity of symptoms of anxiety.
Measured: Baseline
Generalized Anxiety Disorder-7
7 item scale that measures anxiety symptoms on a continuous scale. Scores range from 0-21, with a higher score indicating greater severity of symptoms of anxiety.
Measured: Post 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start12 Aug 2025
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mental Health IssueStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot study to test early stage digital micro-interventions (n=20 per micro-intervention)
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Philip Chow, Ph.D., University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160439
- Sponsor's protocol ID
- 6002
- Other IDs
- 4R37CA248434-05
- Status last verified
- Aug 2026
- First submitted
- 29 Aug 2025
- Last updated
- 13 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Digital Micro-Interventions to Reduce Distress and Increase Wellbeing in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT07160439
- Acronym / sponsor ID
- 6002
- Conditions
- Mental Health Issue, Breast Cancer
- Keywords
- Depression, Anxiety, Well-Being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 8 Sep 2025 (actual)
- Results
- Posted 13 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Digital mental and behavioral health interventions have potential to significantly improve accessibility for the large number of breast cancer survivors who need treatments. However, the landscape of digital interventions tested in this population remains limited, with the few that have been tested primarily focused on reducing symptoms of mental disorders. This is problematic given the range of psychosocial needs among breast cancer survivors, including those who may not have active mental health symptoms, yet could benefit from learning effective coping skills. Moreover, all of these interventions follow a "one size fits all" approach, lacking precision in terms of when, where, and to whom they should be given. The overarching goals of this project are to develop and pilot a variety of digital micro-interventions (DMIs) for breast cancer survivors - highly focused, technology-enabled interventions that can be delivered in the context of a person's daily life with little burden on the individual.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Pilot study to test early stage digital micro-interventions (n=20 per micro-intervention)
| Arm | Type | Receives |
|---|---|---|
| Savoring | Experimental | Behavioral: Digital Micro-InterventionsParticipants are asked to think of a positive and personally meaningful memory to meditate on. They are led through steps to enter their memory, which is then summarized and turned into a meditation practice. |
| Gratitude | Experimental | Behavioral: Digital Micro-InterventionsParticipants are asked to generate a list of things they are grateful for. They are led through an automated process of selecting a source of gratitude and reflecting on it. |
| Challenging UnhelpfulThoughts | Experimental | Behavioral: Digital Micro-InterventionsParticipants are taught how to identify unhelpful thoughts, challenge them, and generate more balanced, helpful thoughts through an automated process that leads them step-by-step. |
| Psychoeducation | Experimental | Behavioral: Digital Micro-InterventionsParticipants receive access to psychoeducation content on mental health, distress, and well-being. They are provided tidbits of information every day to learn from. |
| Behavioral Activation | Experimental | Behavioral: Digital Micro-InterventionsParticipants are led through an automated process of identifying tasks they can accomplish in their daily lives. |
| Acceptance | Experimental | Behavioral: Digital Micro-InterventionsParticipants are led through an automated process of accepting, rather than actively trying to push away, their distressing emotions or thoughts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age = 18 years.
- 0-5 years post-diagnosis of Stage I, II, or III female breast cancer.
- Elevated symptoms of depression and/or anxiety as measured by the PHQ-8 (score > 9) or GAD-7 (score > 7).
Key exclusion criteria (4 listed)
- Receiving individual (1 on 1) treatment for depression and/or anxiety to avoid treatment interference (note, individuals will be permitted to enroll if they are taking antidepressant medication and have not had an appointment to adjust the dosage over the past 2 weeks)
- Active suicidal ideation during the enrollment/screening call based on a trained staff member orally administering the suicidality item from the PHQ-9 to individuals on the phone ("In the last 2 weeks, have you had thoughts that you would be better off dead, or thoughts of hurting yourself in some way?"). If an individual responds in any way other than "not at all" based on the available response options (i.e., either "several days", "more than half the days", or "nearly every day"), or if they mention having suicidal ideation or thoughts of death during the enrollment/screening call, the Pitt-Optimum risk assessment tool will be administered. Only participants deemed low risk may proceed in enrollment; all will be given additional resources.
- Do not have an app-compatible phone (i.e., iOS 10.3 or later or Android 4.0.3 or later).
- Cannot read and speak English (interventions only available in English).
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 |
|---|---|---|
| Digital Micro-InterventionsDigital Micro-Interventions are brief interventions that target specific behavioral and cognitive mechanisms of mental health, designed for brief periods of engagement. | Behavioural | Acceptance, Behavioral Activation, Challenging UnhelpfulThoughts, Gratitude, Psychoeducation, Savoring |
Primary outcome
Evaluation of Digital Micro-Intervention
Time frame: Post 1 week
12 item scale measuring satisfaction and acceptability. Each question is scored on a 0-4 scale with a total raw summed score range of 0-48. Higher scores indicate greater satisfaction and acceptability. Note, this measure could only be administered at post because it requires that participants used the intervention they were assigned, which was provided after they completed the baseline questionnaire battery.
12 secondary outcomes
PROMIS-29 Profile
Time frame: Baseline
PROMIS-29 Profile
Time frame: Post 1 week
Pain, Enjoyment of Life and General Activity (PEG) Scale
Time frame: Baseline
Pain, Enjoyment of Life and General Activity (PEG) Scale
Time frame: Post 1 week
Emotion Regulation Questionnaire
Time frame: Baseline
Emotion Regulation Questionnaire
Time frame: Post 1 week
Insomnia Severity Index
Time frame: Baseline
Insomnia Severity Index
Time frame: Post 1 week
Patient Health Questionnaire-8
Time frame: Baseline
Patient Health Questionnaire-8
Time frame: Post 1 week
Generalized Anxiety Disorder-7
Time frame: Baseline
Generalized Anxiety Disorder-7
Time frame: Post 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Micro-Interventions in people with Mental Health Issue and Breast Cancer, run by University of Virginia 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 13 Aug 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?
Yes. Results are posted in the registry (first posted 13 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Digital Micro-Intervention (time frame: Post 1 week). 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 13 Aug 2026.