NCT07733310

Brief 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. 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.

Trial Health

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Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
29mo left

Started Aug 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 29, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

July 29, 2026

Status Verified

July 1, 2026

Enrollment Period

2.1 years

First QC Date

July 23, 2026

Last Update Submit

July 28, 2026

Conditions

Keywords

DepressionMajor Depressive DisorderMajor Depressive Episode

Outcome Measures

Primary Outcomes (3)

  • Acceptability

    Patient ratings of treatment acceptability

    From enrollment to the end of treatment at 82 weeks

  • Attrition

    Patient attendance records

    From enrollment to the end of treatment at 82 weeks.

  • Adverse Events

    Self-reported adverse events

    From enrollment to the end of treatment at 82 weeks.

Secondary Outcomes (3)

  • Montgomery-Asberg Depression Rating Scale (MADRS)

    From enrollment to the end of treatment at 82 weeks.

  • Patient Health Questionnaire - 9 Item Version (PHQ-9)

    From enrollment to the end of treatment at 82 weeks.

  • Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)

    From enrollment to the end of treatment at 82 weeks.

Study Arms (6)

3 week baseline + ADepT

EXPERIMENTAL

Baseline assessments will be made weekly for 3 weeks, followed by a standard course of ADepT.

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.

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.

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.

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.

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.

Behavioral: Augmented Depression Therapy (ADepT)

Interventions

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.

3 week baseline + ADepT4 week baseline + ADepT5 week baseline + ADepT6 week baseline + ADepT7 week baseline + ADepT8 week baseline + ADepT

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43214, United States

Location

MeSH Terms

Conditions

DepressionDepressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDepressive DisorderMood DisordersMental Disorders

Central Study Contacts

Jay Fournier, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Randomized multiple baseline case series design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 23, 2026

First Posted

July 29, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

July 29, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

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.

Locations