Evaluating Process of Change in Cognitive Behavioral Therapy and Acceptance and Commitment Therapy for Depression

February 5, 2024 updated by: Iony Ezawa, University of Southern California

Researching and Improving Psychotherapy Techniques in Interventions for DEpression (RIPTIDE)

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 150 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Some of the most powerful tools to combat depression come in the form of psychotherapies, including Cognitive Behavioral Therapy (CBT) and Acceptance and Commitment Therapy (ACT). While both treatments have been found to be generally effective in treating depression, they take fundamentally different treatment approaches. In CBT, clients learn techniques to challenge and change maladaptive thought and behavioral patterns. In ACT, clients learn techniques to accept their negative internal experiences and commit to action in line with their values. Despite being among the most effective treatments for depression, both CBT and ACT have a response rate of about only 50%. It is believe there are two key reasons investigators have not been able to improve these response rates. First, very little is known about which specific therapeutic skills are effective in these treatment packages. For example, do cognitive or behavioral change skills lead to therapeutic change in CBT? In ACT, do acceptance or change skills lead to therapeutic change? Second, it is not known which specific treatments or therapeutic skills work better for different individuals. Every individual has diverse needs, and therefore individuals may benefit differently from different treatment packages or from specific skills within each package.

Therefore, investigators plan to run a randomized controlled trial comparing CBT and ACT for depression in order to investigate which specific therapeutic skills are effective in these treatment packages. This approach will also allow investigators to identify predictors of differential response to treatment packages and specific treatment skills.

Upon joining the study, participants are asked to complete surveys for one week prior to starting treatment and again for one week once treatment is completed. During treatment, they are asked to complete surveys throughout the 8 weeks of therapy. Following the 8-week treatment, participants are asked to complete monthly follow-up surveys for 6 months.

There are three main objectives in this study. The first is to compare processes of change across the two treatments (i.e., what works in specific treatments?). The second is to determine client variables that predict differential treatment response (i.e., which treatment works best for a given client?). The third is to evaluate potential moderators of differential response to any specific skills across the treatments (i.e., which specific therapy skill works best for a given client?)

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Iony D Ezawa, PhD
  • Phone Number: (213) 262-9992
  • Email: ezawa@usc.edu

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90007
        • Recruiting
        • University of Southern California
        • Contact:
          • Iony D Ezawa, PhD
          • Phone Number: 213-262-9992
          • Email: ezawa@usc.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • diagnosis of major depressive disorder (MDD) according to DSM-V criteria (APA, 2013)
  • 18 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cognitive Behavioral Therapy
Over 8 sessions, clients learn techniques to challenge and change maladaptive thought and behavioral patterns
Behavioral: Cognitive Behavioral Therapy
Sessions will focus on skills such as behavioral activation, mood tracking, identifying and reframing automatic thoughts, assertion training and smart goals.
Active Comparator: Acceptance and Commitment Therapy
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
Sessions will focus on skills such as mindfulness, acceptance and willingness training, values clarification, committed action, defusion, and self-as-context.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire (PHQ-9)
Time Frame: Post-treatment (8-weeks) and follow-up (6-months)
The PHQ-9 (Kroenke et al., 2001) is a 9-item self-report scale that measures depressive symptom severity. Each item ranges from 0-3 and items are summed upon completing the measures. Higher scores indicate greater depression symptom severity.
Post-treatment (8-weeks) and follow-up (6-months)
Positive and Negative Affect Schedule (PANAS)
Time Frame: Post-treatment (8-weeks) and follow-up (6-months)
The PANAS (Watson et al., 1988) is a 20-item scale that assesses the extent to which participants are experiencing different positive and negative emotions in the present moment. 10-items assess positive emotions and 10-items assess negative emotions. Items range from 1-5 and are summed based on the valence of the emotion. Higher scores indicate more salient experiences of affect.
Post-treatment (8-weeks) and follow-up (6-months)
WHO Quality of Life-Brief (WHOQOL-BREF)
Time Frame: Post-treatment (8-weeks) and follow-up (6-months)
The WHOQOL-BREF (WHOQOL Group; 1998) is a 26-item self-report measure that evaluates four dimensions of quality of life (physical health, psychological health, social relationships, environment. Each item ranges from 1-5 and items are summed upon completing the measure. Higher scores indicate greater satisfaction with quality of life.
Post-treatment (8-weeks) and follow-up (6-months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Investigators

  • Principal Investigator: Iony D Ezawa, PhD, University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2024

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

January 24, 2024

First Submitted That Met QC Criteria

February 5, 2024

First Posted (Actual)

February 7, 2024

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UP-23-01077

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Clinical Trials on Cognitive Behavioral Therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe