NCT06245096

Brief Summary

This study will compare two psychological treatments for major depressive disorder (MDD): cognitive-behavioral therapy (CBT) and acceptance and commitment therapy (ACT). Both treatments are well-studied and supported by evidence as effective options for people experiencing depression. These treatments will be delivered in an online group format via Zoom. The study will enroll up to 100 participants with depression. Half of the participants will receive online group CBT and half will receive online group ACT. There will be up to 10 members in each group. For both conditions, treatment will be provided over 8 weeks, with a 6-month follow-up period. Enrollment will be ongoing and groups will occur simultaneously. Potential participants are asked to complete an initial screening and an intake evaluation to determine eligibility. They will then receive 8-weeks of treatment. Participants will complete self-report questionnaires throughout their time in the study.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2024

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 7, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2026

Completed
Last Updated

December 18, 2025

Status Verified

March 1, 2025

Enrollment Period

1.8 years

First QC Date

January 24, 2024

Last Update Submit

December 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Chain of Change Treatment Diary (ChaCha-TD)

    The ChaCha-TD designed by our research group assesses participants' affect, symptoms, quality of life, significant life events, skills use, and mechanisms of treatment change in daily life.

    Three days per week during the eight-week course of treatment at 8 p.m. on preselected days.

Secondary Outcomes (15)

  • Generalized Anxiety Disorder Questionnaire (GAD-7)

    Intake, Post-treatment (8 weeks)

  • WHO Quality of Life-Brief (WHOQOL-BREF)

    Intake, Post-treatment (8-weeks), and follow-up (6-months)

  • Positive and Negative Affect Schedule (PANAS)

    Intake, Post-treatment (8-weeks), and follow-up (6-months)

  • Patient Health Questionnaire (PHQ-9)

    Intake, Post-treatment (8-weeks), and follow-up (6-months)

  • Discrimination-Related Vigilance Scale (DRVS)

    Intake, Post-treatment (8-weeks)

  • +10 more secondary outcomes

Study Arms (2)

Cognitive Behavioral Therapy

ACTIVE COMPARATOR

Over 8 sessions, clients learn techniques to challenge and change maladaptive thought and behavioral patterns

Behavioral: Cognitive Behavioral Therapy

Acceptance and Commitment Therapy

ACTIVE COMPARATOR

Over 8 sessions, clients learn techniques to accept their negative internal experiences and commit to action in line with their values

Behavioral: Acceptance and Commitment Therapy

Interventions

Sessions will focus on skills such as behavioral activation, mood tracking, identifying and reframing automatic thoughts, assertion training and smart goals.

Cognitive Behavioral Therapy

Sessions will focus on skills such as mindfulness, acceptance and willingness training, values clarification, committed action, defusion, and self-as-context.

Acceptance and Commitment Therapy

Eligibility Criteria

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

You may qualify if:

  • diagnosis of major depressive disorder (MDD) according to DSM-V criteria (APA, 2013)
  • years of age or older
  • access to a private location with a stable internet connection and a working video camera
  • lives in California
  • able to understand and speak English
  • able and willing to give informed consent

You may not qualify if:

  • current diagnosis other than MDD if it constitutes the predominant aspect of the clinical presentation and if it requires treatment other than that being offered
  • clear indication of secondary gain (e.g., court ordered treatment)
  • current suicide risk or significant intentional self-harm in the last six months sufficient to preclude treatment on an outpatient basis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California

Los Angeles, California, 90007, United States

Location

Related Publications (1)

  • Dao A, Bernstein RA, Ramos FN, Beasley B, Ezawa ID. Unpacking the chain of change in group CBT and ACT for depression: A protocol for a randomized clinical trial. Contemp Clin Trials. 2025 Jun;153:107907. doi: 10.1016/j.cct.2025.107907. Epub 2025 Apr 2.

MeSH Terms

Conditions

Depression

Interventions

Cognitive Behavioral TherapyAcceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Iony D Ezawa, PhD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 24, 2024

First Posted

February 7, 2024

Study Start

January 15, 2024

Primary Completion

November 3, 2025

Study Completion

April 27, 2026

Last Updated

December 18, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations