A Pre-post Pilot of a Smartphone Intervention
A Pre-post Pilot of Behavioral Interventions Delivered Through Smartphones
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Philip Chow, PhD
- Telefoonnummer: 434-924-8082
- E-mail: pic2u@virginia.edu
Studie Locaties
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Virginia
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Charlottesville, Virginia, Verenigde Staten, 22904
- University of Virginia
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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).
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Digital Intervention
Participants are provided with a suite of digital micro-interventions over an 8 week period
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Digitale micro-interventies zijn korte interventies die zich richten op specifieke gedrags- en cognitieve mechanismen van geestelijke gezondheid, ontworpen voor korte periodes van betrokkenheid.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Anxiety Symptoms
Tijdsspanne: Baseline
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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.
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Baseline
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Anxiety Symptoms
Tijdsspanne: Post 8-week Intervention
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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.
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Post 8-week Intervention
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Depression symptoms
Tijdsspanne: Baseline
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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.
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Baseline
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Depression symptoms
Tijdsspanne: Post 8-week Intervention
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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.
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Post 8-week Intervention
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 8333
- R37CA248434 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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