Cognitive Behavioral Therapy for Depression: Helping Clients Learn New Skills

Depression Clinical Trial

Official title:

Cognitive Behavioral Therapy for Depression: Helping Clients Learn New Skills

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04673513
• Other study ID #: 2020B0354
• Status: Completed
• Phase: N/A
• Start date: December 11, 2020
• Est. completion date: April 19, 2023

Study information

• Verified date: April 2024
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 19, 2023
• Est. primary completion date: November 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Department of Psychology, The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to relapse per modified version of the Patient Health Questionnaire	The Patient Health Questionnaire is a self-report measure based on the diagnostic criteria for major depressive disorder. A modified version termed the PHQ-9-H (i.e., we changed the wording in the instructions from "Over the past 2 weeks…" to "During the worst 2 weeks…") will be administered to treatment responders every month during the post-treatment follow-up period. Scores range from 0 to 27, with a higher score indicating greater symptom severity.	Immediately post-treatment to 6 months post treatment. Assessments occurred monthly following the posttreatment evaluation
Primary	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.	Weeks 0-12, assessments occurred at every session through week 12.
Primary	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.	Weeks 0-12, assessments occurred at every session aside from session 1 through week 12.
Primary	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.	Weeks 0-12, assessments occurred at intake, week 4, and week 12.
Primary	Change in CBT Skills - Interview at week 12.	The CBT skills interview is a semi-structured interview based measure of CBT skills. Assessors evaluate the clients CBT skills use over the past two weeks with seven items. This interview assesses client skills in using coping strategies central to CBT. Scores range from 0 to 28, with a higher score indicating greater CBT skills.	Weeks 0-12, assessments occurred at intake, week 4, and week 12.
Secondary	Change in Quick Inventory of Depressive Symptoms-Clinician version at week 12.	The Quick Inventory of Depressive Symptoms-Clinician version is a 16-item measure of depressive symptom severity. Scores range from 0 to 27, with higher scores indicating greater depressive symptoms.	Weeks 0-12, assessments occurred at intake, week 4, and week 12.
Secondary	Change in Cognitive Change Immediate at week 12.	The Cognitive Change Sustained is a 5-item measure of the extent to which the client adopted new perspectives in session. It is completed following each session. Scores range from 0 to 30, with a higher score indicating greater cognitive change.	Weeks 0-12, assessments occurred at every session through week 12.
Secondary	Change in Competencies of Cognitive Therapy Scale - client version at week 12.	The Competencies of Cognitive Therapy Scale - client version is a 29-item self-report scale that measures three areas in which clients are expected to acquire competencies from participating in CBT: behavioral activation, coping with automatic thoughts, and knowledge of schemas or core beliefs. Scores range from 29 to 203, with a higher score indicating greater CBT skills.	Weeks 0-12, assessments occurred at intake, week 4, and week 12.
Secondary	Change in Competencies of Cognitive Therapy Scale - therapist version at week 12.	The Competencies of Cognitive Therapy Scale - therapist version is a 9-item self-report scale measures three areas in which clients are expected to acquire competencies from participating in CBT: behavioral activation, coping with automatic thoughts, and knowledge of schemas or core beliefs. Scores range from 0 to 54, with a higher score indicating greater CBT skills.	Weeks 0-12, assessments occurred at intake, week 4, and week 12.
Secondary	Change in Work Social Adjustment Scale at week 12.	The Work Social Adjustment Scale is a 5-item self-report measure of functioning. Items assess the extent to which the client's functioning is impaired with regard to the client's ability to work, manage problems at home, participate in social and private leisure activities, and form close relationships. Scores range from 0 to 40, with a higher score indicating greater impairment.	Weeks 0-12, assessments occurred at intake, week 4, and week 12.