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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Philip Chow, PhD
- Telefonnummer: 434-924-8082
- E-post: pic2u@virginia.edu
Studiesteder
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Virginia
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Charlottesville, Virginia, Forente stater, 22904
- University of Virginia
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Digital Intervention
Participants are provided with a suite of digital micro-interventions over an 8 week period
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Digitale mikrointervensjoner er korte inngrep som retter seg mot spesifikke atferdsmessige og kognitive mekanismer for mental helse, designet for korte perioder med engasjement.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Anxiety Symptoms
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
Baseline
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Depression symptoms
Tidsramme: 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.
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Post 8-week Intervention
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 8333
- R37CA248434 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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