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Completed

NCT Number: NCT02309060

Storytelling Video Intervention for Depressed Primary Care Patients - Open Trial

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Family Care Center of Memorial Hospital, Pawtucket, Rhode Island, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Storytelling Video Intervention (sTVi)

Behavioral

Narrative communication, video-based intervention for depressed primary care patients.

Primary outcomes

  1. Client Satisfaction Questionnaire-8 (CSQ-8)

    Time frame: 4 weeks

Secondary outcomes

  1. Quick Inventory of Depressive Symptomatology-Clinician Rating (QIDS-C)

    Time frame: 4 weeks

  2. Acceptance and Action Questionnaire-II (AAQ-II)

    Time frame: 4 week

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Narrative Intervention to Disseminate ACT for Depression in Primary Care

Acronym: sTVi-Open

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 5, 2014
Registry last updated
Jun 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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