Cognitive Behavioral Therapy for Depression: Helping Clients Learn New Skills

Ohio State University150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Depression

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in Quick Inventory of Depressive Symptoms-Self-Report at week 12.

The Quick Inventory of Depressive Symptoms-Self-Report is a 16-item self-report measure of depressive symptoms. Scores range from 0 to 27, with higher scores indicating greater depressive symptoms.

Time frame: Weeks 0-12, assessments occurred at every session through week 12.

Change in Cognitive Change Sustained at week 12.

The Cognitive Change Sustained is a 9-item measure designed to assess the degree to which experienced cognitive change and used cognitive and behavioral strategies in the days leading up to their session. Scores range from 0 to 54, with a higher score indicating greater cognitive change.

Time frame: Weeks 0-12, assessments occurred at every session aside from session 1 through week 12.

Change in Ways of Responding Scale at week 12.

The Ways of Responding Scale is a measure of the skills taught in CBT for depression. Participants respond to 6 hypothetical stressful situations in which their initial thoughts regarding the event are given. Quality scores range from 0 to 6, with a higher score indicating greater CBT skills.