Cognitive Behavioral Therapy for Depression: Helping Clients Learn New Skills

NCT ID: NCT04673513

Last Updated: 2024-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-11
• Study Completion Date: 2023-04-19

Brief Summary

The purpose of this study is to compare two psychological treatments for major depressive disorder (MDD): cognitive-behavioral therapy (CBT) and CBT-Skill Enhanced (CBT-SE). CBT is well-studied, research-supported treatment for depression. CBT-SE is a variant of CBT that places greater focus on helping clients to developing the skills of CBT.

The study will enroll 150 participants with MDD. Participants will be randomized to CBT or CBT-SE, with 75 participants being assigned to each condition. For both conditions, treatment will be provided over 12 weeks, with a 6 month follow-up period.

Potential participants are asked to complete an initial screening and an intake evaluation to determine eligibility. After entering the study, participants are asked to complete evaluations at 4 weeks and at 12 weeks. They are also asked to respond to self-report instruments before and after each session. Following the 12 week treatment, participants are asked to complete monthly follow-up surveys for 6 months.

The primary objectives of this study are three-fold. The first is to compare the outcomes of the two treatments. The second is to evaluate potential mediators of any treatment differences. The third is to evaluate the process of change in these two versions of CBT.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cognitive Behavioral Therapy (CBT)

Cognitive behavioral therapy will be provided as described in Beck et al. (1979) and Beck (2011), with adaptations for the treatment of comorbid personality disorders as described in Beck et al. (2015).

Group Type: ACTIVE_COMPARATOR

Psychotherapy

Intervention Type: OTHER

In light of COVID-19 considerations, interventions are currently being provided via telehealth technology.

Cognitive Behavioral Therapy - Skill enhanced (CBT-SE)

This condition includes a variation of CBT (as provided in the other condition) with special emphasis on helping clients to develop the skills of CBT.

Group Type: ACTIVE_COMPARATOR

Psychotherapy

Intervention Type: OTHER

In light of COVID-19 considerations, interventions are currently being provided via telehealth technology.

Interventions

Psychotherapy

In light of COVID-19 considerations, interventions are currently being provided via telehealth technology.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. diagnosis of major depressive disorder (MDD) according to DSM-5 criteria;

2. 18 years old or older;

3. residence in the state of Ohio;

4. access to a reliable internet connection (to participate in virtual sessions); and

5. being able and willing to give informed consent.

Exclusion Criteria

1. current or past diagnosis of bipolar disorder or a psychotic disorder;

2. moderate or severe substance use in the past 6 months (where "moderate" is defined as 4-5 symptoms and "severe" is defined as 6 + symptoms of those listed in DSM-5 for each of the substance-related disorders);

3. current disorder other than MDD if it constitutes the predominant aspect of the clinical presentation and if it requires treatment other than that being offered;

4. currently participating in a treatment for an emotional disorder, including any individual psychotherapy or psychiatric medications used to treat a mood or anxiety disorders;

5. clear indication of secondary gain (e.g., court-ordered treatment); and

6. current suicide risk or significant intentional self-harm in the last six months sufficient to preclude treatment on an outpatient basis.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Daniel R. Strunk

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel R Strunk, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

Department of Psychology, The Ohio State University

Columbus, Ohio, United States

Countries

United States

References

Beck AT, Rush AJ, Shaw BF, Emery G. (1979). Cognitive Therapy of Depression. Guilford.

Reference Type: BACKGROUND

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

2020B0354

Identifier Type: -

Identifier Source: org_study_id