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CompletedNCT02309060sTVi-OpenUpdated Jun 25, 2019

Storytelling Video Intervention for Depressed Primary Care Patients - Open Trial

An interventional study of Storytelling Video Intervention (sTVi) in Major Depressive Disorder, sponsored by Butler Hospital. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-25.

Sponsored by Butler Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
11
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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).

Read the detailed description

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.

02

Conditions studied

  • Major Depressive Disorder

Keywords

  • narrative communication
  • depression
  • primary care
  • treatment development
03

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 11 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

Butler Hospital is the lead sponsor of 113 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: Storytelling Video Intervention (sTVi)

Interventions

  • BehavioralStorytelling Video Intervention (sTVi)

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

06

What researchers measure

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

07

Study locations

2 sites
  • Family Care Center of Memorial Hospital
    Pawtucket, Rhode Island 02860, United States
  • Butler Hospital
    Providence, Rhode Island 02906, United States
08

References and documents

Publications

  • Gaudiano BA, Davis CH, Miller IW, Uebelacker LA. Development of a Storytelling Video Self-Help Intervention Based on Acceptance and Commitment Therapy for Major Depression: Open Trial Results. Behav Modif. 2019 Jan;43(1):56-81. doi: 10.1177/0145445517738932. Epub 2017 Nov 1. PubMed 29090593 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02309060
Lead sponsor
Butler Hospital
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Lisa Uebelacker (Co-PI, Butler Hospital) — Principal investigator
First posted
Dec 5, 2014
Start date
Sep 2016
Primary completion
Feb 2017
Completion
Mar 1, 2017
Last update
Jun 25, 2019

Study contacts

Lisa Uebelacker, PhD
principal investigator · Butler Hospital/Brown University
Brandon Gaudiano, PhD
principal investigator · Butler Hospital/Brown University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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