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A Pre-post Pilot of a Smartphone Intervention

A Pre-post Pilot of Behavioral Interventions Delivered Through Smartphones

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07665346
Enrollment
44
Registered
2026-06-24
Start date
2026-07-01
Completion date
2026-09-01
Last updated
2026-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Mental Health Issue

Keywords

depression, anxiety, well-being

Brief 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.

Interventions

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

Sponsors

University of Virginia
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Anxiety SymptomsBaseline7 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 symptomsBaseline8 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.

Countries

United States

Contacts

CONTACTPhilip Chow, PhD
pic2u@virginia.edu434-924-8082

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 25, 2026