- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06245096
Evaluating Process of Change in Cognitive Behavioral Therapy and Acceptance and Commitment Therapy for Depression
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 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.
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90007
- University of Southern California
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
|
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
|
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 |
|---|---|---|
|
Chain of Change Treatment Diary (ChaCha-TD)
Time Frame: Three days per week during the eight-week course of treatment at 8 p.m. on preselected days.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Generalized Anxiety Disorder Questionnaire (GAD-7)
Time Frame: Intake, Post-treatment (8 weeks)
|
The GAD-7 (Spitzer et al., 2006) is a seven-item self-report measure of anxiety symptom severity.
|
Intake, Post-treatment (8 weeks)
|
|
WHO Quality of Life-Brief (WHOQOL-BREF)
Time Frame: Intake, 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.
|
Intake, Post-treatment (8-weeks), and follow-up (6-months)
|
|
Positive and Negative Affect Schedule (PANAS)
Time Frame: Intake, 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.
|
Intake, Post-treatment (8-weeks), and follow-up (6-months)
|
|
Patient Health Questionnaire (PHQ-9)
Time Frame: Intake, 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.
|
Intake, Post-treatment (8-weeks), and follow-up (6-months)
|
|
Discrimination-Related Vigilance Scale (DRVS)
Time Frame: Intake, Post-treatment (8-weeks)
|
The DRVS (Williams, unpublished; and first published by Clark et al., 2006) is a 6-item measure of heightened vigilance in response to experiences of racial discrimination.
This scale will be asked as a follow-up to the Brief PEDQ- CV to assess the extent to which the client is vigilant in their surroundings because of previous discrimination they experienced.
|
Intake, Post-treatment (8-weeks)
|
|
Valuing Questionnaire (VQ)
Time Frame: Intake, Post-treatment (8 weeks)
|
The VQ (Smout et al., 2014) is a 10-item self-report measure that assesses the extent of personal values enactment during the past week.
|
Intake, Post-treatment (8 weeks)
|
|
Automatic Thoughts Questionnaire (ATQ)
Time Frame: Intake, Post-treatment (8 weeks)
|
The ATQ (adapted from Hollon & Kendall, 1980) is a 30- item self-report checklist measure of common automatic thoughts participants may or may not have experienced in the past two weeks.
|
Intake, Post-treatment (8 weeks)
|
|
Emotion Regulation Questionnaire (ERQ)
Time Frame: Intake, Post-treatment (8 weeks)
|
The ERQ (Gross & John, 2003) is a 10-item self-report measure of two emotion regulation strategies, cognitive reappraisal and expressive suppression.
|
Intake, Post-treatment (8 weeks)
|
|
Positive Valence Systems Scale (PVSS-21)
Time Frame: Intake, Post-treatment (8 weeks)
|
The PVSS-21 (Khazanov et al,.
2020 ) is a self-report scale assessing the National Institute of Mental Health Research Domain Criteria Positive Valence Systems constructs (e.g., reward anticipation and initial reward responsiveness).
|
Intake, Post-treatment (8 weeks)
|
|
Multidimensional Scale of Perceived Social Support (MSPSS)
Time Frame: Intake, Post-treatment (8 weeks)
|
The MSPSS (Zimet et al., 1988) is a 12-item measure of perceived adequacy of social support from family, friends, and significant others.
|
Intake, Post-treatment (8 weeks)
|
|
Group Session Rating Scale (GSRS)
Time Frame: Once per week for each session.
|
The GSRS (Quirk et al., 2013) is a client-reported measure that assesses alliance, the quality of individual sessions, and helper skills.
|
Once per week for each session.
|
|
Drexel University ACT/CT Adherence and Competence Rating Scale (DUACRS)
Time Frame: Once per week for each session.
|
The DUACRS (McGrath, 2012) is a therapist-reported measure designed to assess adherence to CBT and ACT treatment components.
While the original measure was designed to assess the extent to which each of these components occurred at every 5-minute interval during a session, we slightly adapted the response options to indicate whether the treatment components occurred at all in the relevant session.
|
Once per week for each session.
|
|
California Psychotherapy Alliance Scale-Group- Therapist Version (CALPAS- G-TV)
Time Frame: Once per week for each session.
|
The CALPAS-G-TV (Gaston & Marmar, 1994) is a therapist- report measure of the therapeutic alliance in group psychotherapy settings.
|
Once per week for each session.
|
|
Clinical Global Impressions Scale (CGI)
Time Frame: Once per week for each session.
|
The CGI (Guy, 1976) is a standard therapist-reported measure for making global assessments of clients' illness and improvement.
|
Once per week for each session.
|
|
Chain of Change Ecological Momentary Assessment (ChaCha-EMA)
Time Frame: Three times per day for the seven days pre- and seven days post-treatment.
|
The ChaCha-EMA consists of the same items assessed in the ChaCha-TD with the exception that questions will be phrased to assess clients' experiences at the moment of survey completion.
|
Three times per day for the seven days pre- and seven days post-treatment.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Iony D Ezawa, PhD, University of Southern California
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- UP-23-01077
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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
-
Massachusetts General HospitalRecruitingDepression | Depression - Major Depressive Disorder | Depression Chronic | Depression in Adults | Depression Disorders | Depression DisorderUnited States
-
University of California, San FranciscoNational Center for Complementary and Integrative Health (NCCIH)Active, not recruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
ProgenaBiomeWithdrawnDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Sorlandet Hospital HFUniversity of Oslo; Karolinska Institutet; Australian Catholic University; Helse...RecruitingAnxiety | Anxiety Depression | Depression Anxiety Disorder | Depression - Major Depressive DisorderNorway
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Lipocine Inc.CompletedDepression, Postpartum | Postnatal Depression | Peripartum Depression | Depression, Post-Partum | Postpartum Depression (PPD) | Post-Natal DepressionUnited States
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Kolby Walker, DO; Brittany KimbleRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryActive, not recruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of MinnesotaCompletedDepression SymptomsUnited States
-
University of CincinnatiNational Center for Complementary and Integrative Health (NCCIH)RecruitingMild DepressionUnited States
Clinical Trials on Cognitive Behavioral Therapy
-
Aleksandra StojanovicRecruitingAnxiety Disorders | Depression - Major Depressive DisorderSerbia
-
Eleos HealthMissouri Department of Mental HealthCompletedMood Disorders | Anxiety DisordersUnited States
-
Regionsenter for barn og unges psykiske helseThe Research Council of NorwayCompletedGeneralized Anxiety Disorder | Social Phobia | Separation Anxiety DisorderNorway
-
Claremont McKenna CollegeUniversity of California, Los AngelesCompleted
-
University of RochesterNational Institute of Nursing Research (NINR)CompletedDepression | Sleep | Stress Disorders, Post-TraumaticUnited States
-
University of South FloridaObsessive Compulsive FoundationCompletedObsessive Compulsive Disorder | Stepped Care Cognitive Behavioral TherapyUnited States
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)Completed
-
Vanderbilt UniversityNational Institute of Mental Health (NIMH)RecruitingDepressionUnited States
-
University of PittsburghWithdrawnPsychosis | Prodromal Symptoms | Prodromal Stage | Prodromal StatesUnited States
-
Duke UniversityCompleted