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Cognitive Behavioral Therapy for Depression: Helping Clients Learn New Skills

Primary Purpose

Depression

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychotherapy
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Cognitive Behavioral Therapy, Depression, Randomized Clinical Trial, Cognitive Behavioral Skills

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Department of Psychology, The Ohio State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cognitive Behavioral Therapy (CBT)

Cognitive Behavioral Therapy - Skill enhanced (CBT-SE)

Arm 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).

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
December 12, 2020
Last Updated
March 22, 2023
Sponsor
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT04673513
Brief Title
Cognitive Behavioral Therapy for Depression: Helping Clients Learn New Skills
Official Title
Cognitive Behavioral Therapy for Depression: Helping Clients Learn New Skills
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 11, 2020 (Actual)
Primary Completion Date
November 2, 2022 (Actual)
Study Completion Date
May 6, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Cognitive Behavioral Therapy, Depression, Randomized Clinical Trial, Cognitive Behavioral Skills

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy (CBT)
Arm Type
Active Comparator
Arm 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).
Arm Title
Cognitive Behavioral Therapy - Skill enhanced (CBT-SE)
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Psychotherapy
Intervention Description
In light of COVID-19 considerations, interventions are currently being provided via telehealth technology.
Primary Outcome Measure Information:
Title
Change in Quick Inventory of Depressive Symptoms-Self-Report at week 12.
Description
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.
Title
Change in Cognitive Change Sustained at week 12.
Description
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.
Title
Change in Ways of Responding Scale at week 12.
Description
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.
Time Frame
Weeks 0-12, assessments occurred at intake, week 4, and week 12.
Title
Change in CBT Skills - Interview at week 12.
Description
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.
Time Frame
Weeks 0-12, assessments occurred at intake, week 4, and week 12.
Secondary Outcome Measure Information:
Title
Change in Quick Inventory of Depressive Symptoms-Clinician version at week 12.
Description
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.
Time Frame
Weeks 0-12, assessments occurred at intake, week 4, and week 12.
Title
Change in Cognitive Change Immediate at week 12.
Description
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.
Time Frame
Weeks 0-12, assessments occurred at every session through week 12.
Title
Change in Competencies of Cognitive Therapy Scale - client version at week 12.
Description
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.
Time Frame
Weeks 0-12, assessments occurred at intake, week 4, and week 12.
Title
Change in Competencies of Cognitive Therapy Scale - therapist version at week 12.
Description
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.
Time Frame
Weeks 0-12, assessments occurred at intake, week 4, and week 12.
Title
Change in Work Social Adjustment Scale at week 12.
Description
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.
Time Frame
Weeks 0-12, assessments occurred at intake, week 4, and week 12.
Other Pre-specified Outcome Measures:
Title
Time to relapse per modified version of the Patient Health Questionnaire
Description
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.
Time Frame
Immediately post-treatment to 6 months post treatment. Assessments occurred monthly following the posttreatment evaluation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of major depressive disorder (MDD) according to DSM-5 criteria; 18 years old or older; residence in the state of Ohio; access to a reliable internet connection (to participate in virtual sessions); and being able and willing to give informed consent. Exclusion Criteria: current or past diagnosis of bipolar disorder or a psychotic disorder; 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); 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; currently participating in a treatment for an emotional disorder, including any individual psychotherapy or psychiatric medications used to treat a mood or anxiety disorders; clear indication of secondary gain (e.g., court-ordered treatment); and current suicide risk or significant intentional self-harm in the last six months sufficient to preclude treatment on an outpatient basis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel R Strunk, PhD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychology, The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We will consider requests for data sharing, pending approval from our IRB.
Citations:
Citation
Beck AT, Rush AJ, Shaw BF, Emery G. (1979). Cognitive Therapy of Depression. Guilford.
Results Reference
background

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Cognitive Behavioral Therapy for Depression: Helping Clients Learn New Skills

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