Depression / Major Depressive DisorderNCT07733310
Augmented Depression Therapy (ADepT) Case Series
A study testing Augmented Depression Therapy (ADepT) in people with Depression / Major Depressive Disorder, run by Ohio State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression / Major Depressive Disorder
- What is being tested?
- Augmented Depression Therapy (ADepT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43214
Jay Fournier, PhD, 614-814-6485, jay.fournier@osumc.edu
About this study
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.
- Conditions
- Depression / Major Depressive Disorder
- Being tested
- Augmented Depression Therapy (ADepT)
- Keywords
- Depression, Major Depressive Disorder, Major Depressive Episode
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented Depression Therapy (ADepT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 3 week baseline + ADepT | Experimental | Baseline assessments will be made weekly for 3 weeks, followed by a standard course of ADepT. Receives: Behavioral: Augmented Depression Therapy (ADepT) |
| 4 week baseline + ADepT | Experimental | Baseline assessments will be made weekly for 4 weeks, followed by a standard course of ADepT. Receives: Behavioral: Augmented Depression Therapy (ADepT) |
| 5 week baseline + ADepT | Experimental | Baseline assessments will be made weekly for 5 weeks, followed by a standard course of ADepT. Receives: Behavioral: Augmented Depression Therapy (ADepT) |
| 6 week baseline + ADepT | Experimental | Baseline assessments will be made weekly for 6 weeks, followed by a standard course of ADepT. Receives: Behavioral: Augmented Depression Therapy (ADepT) |
| 7 week baseline + ADepT | Experimental | Baseline assessments will be made weekly for 7 weeks, followed by a standard course of ADepT. Receives: Behavioral: Augmented Depression Therapy (ADepT) |
| 8 week baseline + ADepT | Experimental | Baseline assessments will be made weekly for 8 weeks, followed by a standard course of ADepT. Receives: Behavioral: Augmented Depression Therapy (ADepT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
Patient ratings of treatment acceptability
Measured: From enrollment to the end of treatment at 82 weeks
Attrition
Patient attendance records
Measured: From enrollment to the end of treatment at 82 weeks.
Adverse Events
Self-reported adverse events
Measured: From enrollment to the end of treatment at 82 weeks.
Secondary outcomes (3)
Montgomery-Asberg Depression Rating Scale (MADRS)
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.
Measured: From enrollment to the end of treatment at 82 weeks.
Patient Health Questionnaire - 9 Item Version (PHQ-9)
The PHQ-9 is a 9-item self-report measure of depression severity. Min=0, Max=27, higher scores indicate worse depression.
Measured: From enrollment to the end of treatment at 82 weeks.
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
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.
Measured: From enrollment to the end of treatment at 82 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression / Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Single group
- Model description
- Randomized multiple baseline case series design
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jay Fournier, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733310
- Sponsor's protocol ID
- 20251473
- Status last verified
- Oct 2026
- First submitted
- 23 Jul 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IRB approved personnel will have access to identifiable data. De-identified data may be shared with other research groups examining similar questions or as a requirement for publication in certain journals.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmented Depression Therapy (ADepT) Case Series
- ClinicalTrials.gov ID
- NCT07733310
- Acronym / sponsor ID
- 20251473
- Conditions
- Depression / Major Depressive Disorder
- Keywords
- Depression, Major Depressive Disorder, Major Depressive Episode
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 Jul 2026 (actual)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Randomized multiple baseline case series design
| Arm | Type | Receives |
|---|---|---|
| 3 week baseline + ADepT | Experimental | Behavioral: Augmented Depression Therapy (ADepT)Baseline assessments will be made weekly for 3 weeks, followed by a standard course of ADepT. |
| 4 week baseline + ADepT | Experimental | Behavioral: Augmented Depression Therapy (ADepT)Baseline assessments will be made weekly for 4 weeks, followed by a standard course of ADepT. |
| 5 week baseline + ADepT | Experimental | Behavioral: Augmented Depression Therapy (ADepT)Baseline assessments will be made weekly for 5 weeks, followed by a standard course of ADepT. |
| 6 week baseline + ADepT | Experimental | Behavioral: Augmented Depression Therapy (ADepT)Baseline assessments will be made weekly for 6 weeks, followed by a standard course of ADepT. |
| 7 week baseline + ADepT | Experimental | Behavioral: Augmented Depression Therapy (ADepT)Baseline assessments will be made weekly for 7 weeks, followed by a standard course of ADepT. |
| 8 week baseline + ADepT | Experimental | Behavioral: Augmented Depression Therapy (ADepT)Baseline assessments will be made weekly for 8 weeks, followed by a standard course of ADepT. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Augmented Depression Therapy (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. | Behavioural | 3 week baseline + ADepT, 4 week baseline + ADepT, 5 week baseline + ADepT, 6 week baseline + ADepT, 7 week baseline + ADepT, 8 week baseline + ADepT |
Primary outcome
Acceptability
Time frame: From enrollment to the end of treatment at 82 weeks
Patient ratings of treatment acceptability
Attrition
Time frame: From enrollment to the end of treatment at 82 weeks.
Patient attendance records
Adverse Events
Time frame: From enrollment to the end of treatment at 82 weeks.
Self-reported adverse events
3 secondary outcomes
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: 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.
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
Time frame: From enrollment to the end of treatment at 82 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Yes. Only IRB approved personnel will have access to identifiable data. De-identified data may be shared with other research groups examining similar questions or as a requirement for publication in certain journals.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented Depression Therapy (ADepT) in people with Depression / Major Depressive Disorder, run by Ohio State University at 1 site 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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jay Fournier, Ph.D. (614-814-6485, Jay.Fournier@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: From enrollment to the end of treatment at 82 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2026.