A Pre-post Pilot of a Smartphone Intervention

NCT07665346 — Not applicable, Not yet recruiting, 44 participants, University of Virginia

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A Pre-post Pilot of Behavioral Interventions Delivered Through Smartphones

Registry	NCT07665346
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	44 (Estimated)
Sponsor	University of Virginia (Other); collaborators: National Cancer Institute (NCI)
Conditions	Mental Health Issue, Breast Cancer
Interventions	Digital Micro-Interventions (Behavioral)
Dates	start 2026-07-01 (estimated), primary completion 2026-09-01 (estimated), completion 2026-09-01 (estimated), first posted 2026-06-24, last updated 2026-06-24
Locations	1 site in United States

-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 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.

Digital health interventions delivered through smartphones have strong potential to improve access to care for the large number of breast cancer survivors who need mental and behavioral health support. There is a need to evaluate a range of supportive interventions that target different aspects of mental health, including negative thinking, coping skills, and knowledge. Our research team has previously tested individual digital interventions in relatively small samples, and found that they were effective in reducing mood symptoms among women with breast cancer.

The ultimate goal of this project is to evaluate how integrating these interventions into a single 8-week long app program affects mood and overall mental health in breast cancer survivors. The digital micro-interventions to be tested in this study are brief interventions that target specific behavioral and cognitive mechanisms of mental health. These include skills such as reducing negative thinking patterns, increasing knowledge of mental health factors, fostering a grateful outlook, promoting the practice of relaxation breathing, savoring positive memories, and acceptance-based mindfulness approaches.

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+Arms and interventions

Arm	Type	Interventions	Description
Digital Intervention	Experimental	Behavioral: Digital Micro-Interventions	Participants are provided with a suite of digital micro-interventions over an 8 week period

Digital Micro-Interventions (Behavioral): Digital Micro-Interventions are brief interventions that target specific behavioral and cognitive mechanisms of mental health, designed for brief periods of engagement.

+Outcome measures

Primary outcomes

Anxiety Symptoms [Baseline]: 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.
Anxiety Symptoms [Post 8-week Intervention]: 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.
Depression symptoms [Baseline]: 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.
Depression symptoms [Post 8-week Intervention]: 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.

+Eligibility

Sex: Female, ages: 18 Years to any

Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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
* cannot read and speak English (intervention and measures only available in English).

+Locations (1)

Facility	City	Country	Status
University of Virginia	Charlottesville, Virginia	United States

+Funding

NIH grants: R37CA248434