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Storytelling Video Intervention for Depressed Primary Care Patients - Open Trial (sTVi-Open)

24. juni 2019 opdateret af: Lisa Uebelacker, Butler Hospital

Narrative Intervention to Disseminate ACT for Depression in Primary Care

The overall aim of this program of research is to develop a collaborative narrative intervention for patients with depression being treated in primary care.

The purpose of the proposed project is to establish the feasibility, acceptability, and preliminary effects of our newly developed narrative intervention on depression.

To achieve the specific aims, the investigators will conduct an open trial to further develop and refine the intervention (n = 10).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The public health impact of existing treatments for major depression is limited by our ability to disseminate those treatments. There is a particular need to find innovative ways to disseminate key principles of empirically supported psychotherapy in primary care settings. Narrative communication is an alternative way to disseminate psychotherapy behavior change principles. Narrative communication refers to "storytelling" -real people talking about their struggles and successful ways of coping. An advantage of narrative communication is that it can be easily distributed (by video) and may reach people who do not have access to other technologies or who experience barriers to traditional psychotherapy. We propose that key principles of a type of cognitive-behavioral therapy (Acceptance and Commitment Therapy, or ACT) can be readily disseminated through a video storytelling intervention. ACT is an empirically supported therapy for depression. Together with a video production firm with a record of working in healthcare and developing documentary-style videos, we will produce a storytelling video intervention (sTVi).

Our aim is to conduct a small open trial (n = 10) of antidepressant medication treatment as usual + sTVi. Assessments will occur at baseline and 4 weeks (post-treatment). We will examine the feasibility and acceptability of sTVi (e.g., uptake and completion of sTVi, engagement with videos, and understanding of key ACT principles) and of this research design. We will examine treatment effects (within relevant confidence intervals) on outcomes (e.g., depression severity). We will examine change in potential mechanisms, i.e., ACT-consistent coping strategies derived from key ACT principles.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

11

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Rhode Island
      • Pawtucket, Rhode Island, Forenede Stater, 02860
        • Family Care Center of Memorial Hospital
      • Providence, Rhode Island, Forenede Stater, 02906
        • Butler Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Meets DSM-5 criteria for current or lifetime major depressive disorder.
  2. No Lifetime diagnosis of bipolar disorder, schizophrenia, or chronic psychotic condition.
  3. No current hazardous illicit drug or alcohol use.
  4. No suicidal ideation or behavior requiring immediate attention.
  5. Depression symptom severity: a Quick Inventory of Depressive Symptoms (QIDS) score >11.
  6. Taking an antidepressant medication for at least 6 weeks; prescribed by their primary care provider.
  7. Not in psychotherapy during the study period.
  8. Have a PCP at our enrollment site.
  9. If pregnant, less than 24 weeks gestation.
  10. English speaking.
  11. Aged 18 or older.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Storytelling Video Intervention (sTVi)

We will develop a series of 4 videos, each episode approximately 30 minutes long, which will illustrate the key principles of Acceptance and Commitment Therapy.

We will add a short, non-narrative, epilogue at the end of each of the 4 episodes that summarizes key messages and provides information on identifying signs of depression and suggestions for efficacious treatments.

In addition, we will develop an accompanying "personal journal" for participants that includes a brief self-help guide which encourages participants to write about what they learned in the videos and how they will take similar steps in their own lives to cope with depression.
Adfærdsmæssigt: Storytelling Video Intervention (sTVi)
Narrative communication, video-based intervention for depressed primary care patients.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Kundetilfredshedsspørgeskema-8 (CSQ-8)
Tidsramme: 4 uger
4 uger

Sekundære resultatmål

Resultatmål
Tidsramme
Quick Inventory of Depressive Symptomatology-Clinician Rating (QIDS-C)
Tidsramme: 4 weeks
4 weeks
Acceptance and Action Questionnaire-II (AAQ-II)
Tidsramme: 4 week
4 week

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Butler Hospital

Samarbejdspartnere

National Institute of Mental Health (NIMH)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2016

Primær færdiggørelse (Faktiske)

1. februar 2017

Studieafslutning (Faktiske)

1. marts 2017

Datoer for studieregistrering

Først indsendt

3. december 2014

Først indsendt, der opfyldte QC-kriterier

3. december 2014

Først opslået (Skøn)

5. december 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. juni 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. juni 2019

Sidst verificeret

1. juni 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • sTVi-1
  • R34MH103568 (U.S. NIH-bevilling/kontrakt)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Større depressiv lidelse

Kliniske forsøg med Storytelling Video Intervention (sTVi)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Germany

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner