- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07733310
Augmented Depression Therapy (ADepT) Case Series
This research study plans to examine the use of Augmented Depression Therapy (ADepT) in order to evaluate what patients think about ADepT and how well it works. ADepT is a type of therapy that builds wellbeing and is being provided to you as standard of care.
ADepT treatment consists of 15 therapy sessions (typically provided weekly) with each session lasting around 60 minutes. Following these sessions, you can receive five optional booster sessions over the next 12 months with each of these lasting around 60 minutes. Ultimately, the timing and duration of these sessions will be determined between you and your provider and scheduled accordingly.
As part of this study you will be randomized (randomly assigned) to different research assessment lengths before the start of treatment and then will complete assessments for the 12 months following the end of the weekly portion of ADepT treatment. The length of your participation will be between 70 weeks to 82 weeks.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jay Fournier, Ph.D.
- Phone Number: 614-814-6485
- Email: Jay.Fournier@osumc.edu
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43214
- The Ohio State University Wexner Medical Center
-
Contact:
- Jay Fournier, PhD
- Phone Number: 614-814-6485
- Email: jay.fournier@osumc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 18 -65
- Currently experiencing a major depressive episode based on the Quick Structured Clinical Interview for DSM-5 Disorders (QuickSCID-5; First & Williams, 2021)
- Scoring > 10 on the PHQ-9
- Have sufficient knowledge of written and spoken English to provide consent and utilize therapy resources and take assessment measures throughout the protocol without the assistance of a translator.
Exclusion Criteria:
- Diagnosis of a psychotic or bipolar disorder
- History of learning disabilities or organic brain change (e.g., from injury or from neurological disorders)
- Active alcohol or substance use disorder or level of use that would interfere with ability to engage in ADepT treatment
- Current marked risk to self (self-harm or suicidal ideation) that cannot be managed safely within the ADepT treatment frame
- Patients cannot be enrolled while they are currently receiving psychotherapy from a different provider in line with current clinic policy and APA ethical guidelines. The possibility of switching providers/treatments will be addressed following established departmental policies and procedures, transcranial magnetic stimulation, ketamine, esketamine, or electroconvulsive therapy. Patients receiving a stable dose of an antidepressant agent will be considered eligible.
- Presence of another psychiatric disorder judged to be primary
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 3 week baseline + ADepT
Baseline assessments will be made weekly for 3 weeks, followed by a standard course of ADepT.
|
ADepT is a solution-focused behavioral health intervention that blends techniques from cognitive, behavioral, and acceptance-based treatments to help patients manage symptoms of depression and increase wellbeing.
It consists of 15 acute treatment sessions and up to 5 booster sessions.
|
|
Experimental: 4 week baseline + ADepT
Baseline assessments will be made weekly for 4 weeks, followed by a standard course of ADepT.
|
ADepT is a solution-focused behavioral health intervention that blends techniques from cognitive, behavioral, and acceptance-based treatments to help patients manage symptoms of depression and increase wellbeing.
It consists of 15 acute treatment sessions and up to 5 booster sessions.
|
|
Experimental: 5 week baseline + ADepT
Baseline assessments will be made weekly for 5 weeks, followed by a standard course of ADepT.
|
ADepT is a solution-focused behavioral health intervention that blends techniques from cognitive, behavioral, and acceptance-based treatments to help patients manage symptoms of depression and increase wellbeing.
It consists of 15 acute treatment sessions and up to 5 booster sessions.
|
|
Experimental: 6 week baseline + ADepT
Baseline assessments will be made weekly for 6 weeks, followed by a standard course of ADepT.
|
ADepT is a solution-focused behavioral health intervention that blends techniques from cognitive, behavioral, and acceptance-based treatments to help patients manage symptoms of depression and increase wellbeing.
It consists of 15 acute treatment sessions and up to 5 booster sessions.
|
|
Experimental: 7 week baseline + ADepT
Baseline assessments will be made weekly for 7 weeks, followed by a standard course of ADepT.
|
ADepT is a solution-focused behavioral health intervention that blends techniques from cognitive, behavioral, and acceptance-based treatments to help patients manage symptoms of depression and increase wellbeing.
It consists of 15 acute treatment sessions and up to 5 booster sessions.
|
|
Experimental: 8 week baseline + ADepT
Baseline assessments will be made weekly for 8 weeks, followed by a standard course of ADepT.
|
ADepT is a solution-focused behavioral health intervention that blends techniques from cognitive, behavioral, and acceptance-based treatments to help patients manage symptoms of depression and increase wellbeing.
It consists of 15 acute treatment sessions and up to 5 booster sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability
Time Frame: From enrollment to the end of treatment at 82 weeks
|
Patient ratings of treatment acceptability
|
From enrollment to the end of treatment at 82 weeks
|
|
Attrition
Time Frame: From enrollment to the end of treatment at 82 weeks.
|
Patient attendance records
|
From enrollment to the end of treatment at 82 weeks.
|
|
Adverse Events
Time Frame: From enrollment to the end of treatment at 82 weeks.
|
Self-reported adverse events
|
From enrollment to the end of treatment at 82 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: From enrollment to the end of treatment at 82 weeks.
|
The MADRS is a clinician-administered, 10-item assessment tool used to measure the severity of depressive symptoms and monitor changes in depression over time.
Min=0, Max=60, higher scores indicate worse depression.
|
From enrollment to the end of treatment at 82 weeks.
|
|
Patient Health Questionnaire - 9 Item Version (PHQ-9)
Time Frame: From enrollment to the end of treatment at 82 weeks.
|
The PHQ-9 is a 9-item self-report measure of depression severity.
Min=0, Max=27, higher scores indicate worse depression.
|
From enrollment to the end of treatment at 82 weeks.
|
|
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
Time Frame: From enrollment to the end of treatment at 82 weeks.
|
The WEMWBS is a 14-item self-report questionnaire designed to measure positive mental wellbeing, including emotional, psychological, and social functioning.
Min=14, Max=70, higher scores indicate higher levels of wellbeing.
|
From enrollment to the end of treatment at 82 weeks.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20251473
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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