A Preliminary Evaluation of Digital Behavioral Interventions

Not Applicable

Recruiting

• Conditions: Mental Health Issue; Breast Cancer

• Registration Number: NCT07160439
• Lead Sponsor: University of Virginia

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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-08-12
• Study First Submitted: 2025-08-29
• Study First Submitted QC: 2025-08-29
• Status Verified: 2025-09
• Study First Posted: 2025-09-08
• Last Update Submitted: 2025-09-08
• Last Update Posted: 2025-09-09
• Primary Completion: 2026-06-12
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

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 (i.e., iOS 10.3 or later or Android 4.0.3 or later).
• Cannot read and speak English (interventions only available in English).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evaluation of Digital Micro-Intervention	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.

Secondary Outcome Measures

Name	Time	Method
Insomnia Severity Index	Post 1 week	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.
PROMIS-29 Profile	Post 1 week	28 items that measure aspects of physical and mental health. Each question is scored on a 1-5 scale with a total raw score range of 28-140. Higher scores indicate worse overall health. A 29th item that assesses pain from 1-10 was omitted to limit redundancy with another pain measure.
Patient Health Questionnaire-8	Post 1 week	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.
Pain, Enjoyment of Life and General Activity (PEG) Scale	Post 1 week	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.
Emotion Regulation Questionnaire	Post 1 week	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.
Generalized Anxiety Disorder-7	Post 1 week	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.

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States