A Pre-post Pilot of a Smartphone Intervention
A Pre-post Pilot of Behavioral Interventions Delivered Through Smartphones
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests an 8-week smartphone app to see how it affects mood and mental health in breast cancer survivors. The app teaches skills like handling negative thoughts, slow breathing, and focusing on positive memories. It is for women diagnosed with stage I, II, or III breast cancer within the past 5 years who have symptoms of depression or anxiety.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 18 years, as listed in the study criteria.
- Diagnosed with stage I, II, or III female breast cancer within the past 5 years.
- Have raised levels of depression or anxiety symptoms: a score above 9 on the PHQ-8 depression survey or above 7 on the GAD-7 anxiety survey.
Who can't join
- Getting one-on-one treatment for depression or anxiety. People taking antidepressant medicine may join if they have not had a visit to adjust their dose in the past 2 weeks.
- Thoughts of death, suicide, or self-harm reported during the screening call require a safety check. Only people found to be at low risk may continue joining the study. Everyone checked will get extra support resources.
- Do not have a phone that can run the app.
- Cannot read and speak English.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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).
Study sites (1)
VA
- University of Virginia · Charlottesville, VA 22904More trials in Charlottesville