Cognitive Behavioral Therapy for Depression: Helping Clients Learn New Skills

The Ohio State University

Status: Completed

Conditions: Depression

Treatments: Other: Psychotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04673513

2020B0354

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Cognitive Behavioral Therapy (CBT)

Active Comparator group

Description:

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).

Treatment:

Other: Psychotherapy

Cognitive Behavioral Therapy - Skill enhanced (CBT-SE)

Active Comparator group

Description:

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.

Treatment:

Other: Psychotherapy