NCT02309060

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable major-depressive-disorder

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable major-depressive-disorder

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2014

Completed
1.7 years until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

June 25, 2019

Status Verified

June 1, 2019

Enrollment Period

5 months

First QC Date

December 3, 2014

Last Update Submit

June 24, 2019

Conditions

Major Depressive Disorder

Keywords

narrative communicationdepressionprimary caretreatment development

Outcome Measures

Primary Outcomes (1)

  • Client Satisfaction Questionnaire-8 (CSQ-8)

    4 weeks

Secondary Outcomes (2)

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

    4 weeks

  • Acceptance and Action Questionnaire-II (AAQ-II)

    4 week

Study Arms (1)

Storytelling Video Intervention (sTVi)

EXPERIMENTAL

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

Storytelling Video Intervention (sTVi)BEHAVIORAL

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

Storytelling Video Intervention (sTVi)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Family Care Center of Memorial Hospital

Pawtucket, Rhode Island, 02860, United States

Location

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (1)

  • 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.

    PMID: 29090593RESULT

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Lisa Uebelacker, PhD

    Butler Hospital/Brown University

    PRINCIPAL INVESTIGATOR

  • Brandon Gaudiano, PhD

    Butler Hospital/Brown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-PI

Study Record Dates

First Submitted

December 3, 2014

First Posted

December 5, 2014

Study Start

September 1, 2016

Primary Completion

February 1, 2017

Study Completion

March 1, 2017

Last Updated

June 25, 2019

Record last verified: 2019-06

Locations

US(2)