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Behavioral Intervention
Partially Supported for Depression
N/A
Waitlist Available
Led By Gary G Bennett, PhD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 12 weeks
Awards & highlights
Study Summary
This study is evaluating whether an online treatment for depression and anxiety symptoms is feasible for individuals with limited educational attainment.
Eligible Conditions
- Depression
- Anxiety
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change Between Baseline and Post-Treatment System Usability Scale Score
Change in COPE Inventory - Avoidance Factor Score
Change in Cognitive Flexibility Inventory Score
+3 moreSecondary outcome measures
Change in Overall Anxiety Severity and Impairment Scale Score
Change in Overall Depression Severity and Impairment Scale Score
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Partially SupportedExperimental Treatment2 Interventions
Participants in the partially supported arm will receive all aspects of the intervention described above, with no differences between arms for the first seven weeks of the intervention (Modules 1-6). Participants will be introduced to their study therapist in week 8, at the start of Module 7 via email. During Module 7 (exposure; weeks 8-11), participants will receive four video therapy sessions. Session content will be based on principles of exposure therapy (developing a personalized exposure hierarchy, live demonstrations of exposure exercises, in-session exposure practices, post-exposure processing, home practice assignments, and therapist feedback).
Group II: UnsupportedActive Control1 Intervention
Participants in this arm will receive a 12-week Unified Protocol intervention delivered via the same web platform. Each week, participants will complete the following content:
depression survey,
anxiety survey,
information about their symptom change over time,
psychoeducational text
practice exercises,
home practice instructions,
writing exercise,
home practice worksheets.
In the first week, participants will receive an emailed welcome message followed by a link to the first week's content. For every following week, participants will receive an email at the start of the week with automatically generated feedback on intervention usage, behavior change, and symptom change, as well as the link to the new week's intervention content.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Unified Protocol
2020
N/A
~390
Therapist Support
2021
N/A
~30
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Who is running the clinical trial?
Charles Lafitte FoundationUNKNOWN
Duke UniversityLead Sponsor
2,363 Previous Clinical Trials
3,420,480 Total Patients Enrolled
74 Trials studying Depression
34,330 Patients Enrolled for Depression
Jack Brooks, MAStudy Director - Duke University
Duke University
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