Major Depressive DisordersTVi-OpenNCT02309060
Storytelling Video Intervention for Depressed Primary Care Patients - Open Trial
A study testing Storytelling Video Intervention (sTVi) in people with Major Depressive Disorder, run by Butler Hospital at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Storytelling Video Intervention (sTVi)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2016to 1 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Family Care Center of Memorial Hospital
Pawtucket, Rhode Island, 02860
Butler Hospital
Providence, Rhode Island, 02906
About this study
Official title: 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).
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.
- Conditions
- Major Depressive Disorder
- Being tested
- Storytelling Video Intervention (sTVi)
- Keywords
- narrative communication, depression, primary care, treatment development
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Storytelling Video Intervention (sTVi)Behavioural
Narrative communication, video-based intervention for depressed primary care patients.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Storytelling Video Intervention (sTVi) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Client Satisfaction Questionnaire-8 (CSQ-8)
Measured: 4 weeks
Secondary outcomes (2)
Quick Inventory of Depressive Symptomatology-Clinician Rating (QIDS-C)
Measured: 4 weeks
Acceptance and Action Questionnaire-II (AAQ-II)
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startSep 2016
- Primary completionFeb 2017
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Lisa Uebelacker, Butler Hospital
- Investigators
- Lisa Uebelacker, PhD, Principal investigator, Butler Hospital/Brown UniversityBrandon Gaudiano, PhD, Principal investigator, Butler Hospital/Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309060
- Sponsor's protocol ID
- sTVi-1
- Other IDs
- R34MH103568
- Acronym
- sTVi-Open
- Status last verified
- Jun 2019
- First submitted
- 3 Dec 2014
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Narrative Intervention to Disseminate ACT for Depression in Primary Care
- ClinicalTrials.gov ID
- NCT02309060
- Acronym / sponsor ID
- sTVi-Open / sTVi-1
- Conditions
- Major Depressive Disorder
- Keywords
- narrative communication, depression, primary care, treatment development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 5 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Storytelling Video Intervention (sTVi) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Storytelling Video Intervention (sTVi)Narrative communication, video-based intervention for depressed primary care patients. | Behavioural | Storytelling Video Intervention (sTVi) |
Primary outcome
Client Satisfaction Questionnaire-8 (CSQ-8)
Time frame: 4 weeks
2 secondary outcomes
Quick Inventory of Depressive Symptomatology-Clinician Rating (QIDS-C)
Time frame: 4 weeks
Acceptance and Action Questionnaire-II (AAQ-II)
Time frame: 4 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Results publication: PubMed 29090593Gaudiano 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.
Related trials for Major Depressive Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Uebelacker, PhD principal investigator
Butler Hospital/Brown University
Brandon Gaudiano, PhD principal investigator
Butler Hospital/Brown University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Storytelling Video Intervention (sTVi) in people with Major Depressive Disorder, run by Butler Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Client Satisfaction Questionnaire-8 (CSQ-8) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02309060, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2019.