Patient Characteristics and Cognitive vs. Behavioral Therapies for Depression
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of major depressive disorder (MDD) according to DSM-IV criteria (APA, 1994)
- Able and willing to give informed consent
Exclusion Criteria:
- History of bipolar affective disorder or psychosis
- Current Axis I disorder other than MDD if it constitutes the predominant aspect of the clinical presentation and if it requires treatment other than that being offered
- History of substance dependence in the past six months
- Subnormal intellectual potential (IQ below 80, testing to be initiated if clinically indicated)
- Clear indication of secondary gain (e.g., court ordered treatment)
- Current suicide risk or significant intentional self-harm in the last six months sufficient to preclude treatment on an outpatient basis
- If clients currently being treated with a medication for depression: (1) no change in medication and a stable dose for at least 1 month prior to their initial assessment; and (2) agreeing to not make changes to medication or medication dose during the study.
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-only Intervention
Behavioral-only Intervention
Arm Description
This condition includes cognitive interventions drawn from cognitive therapy as described in Beck, Rush, Shaw, & Emery (1979).
The condition includes behavioral interventions drawn from cognitive therapy as described in Beck, Rush, Shaw, & Emery (1979).
Outcomes
Primary Outcome Measures
Change in Hamilton Rating Scale for Depression at week 8 and week 16
The Hamilton Rating Scale for Depression is a 17-item interviewer evaluated assessment of depressive symptoms. Scores range from 0 to 52, with higher scores indicating greater depressive symptoms.
Secondary Outcome Measures
Change in Beck Depression Inventory-II at week 8 and week 16
The Beck Depression Inventory-II is a 21-item self-report measure of depressive symptoms. Scores range from 0 to 63, with higher scores indicating greater depressive symptoms.
Full Information
NCT ID
NCT04529694
First Posted
August 14, 2020
Last Updated
August 24, 2020
Sponsor
Ohio State University
Collaborators
Social Sciences and Humanities Research Council (Canada)
1. Study Identification
Unique Protocol Identification Number
NCT04529694
Brief Title
Patient Characteristics and Cognitive vs. Behavioral Therapies for Depression
Official Title
PATIENT CHARACTERISTICS AND COGNITIVE BEHAVIOR THERAPY FOR DEPRESSION
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
October 20, 2011 (Actual)
Primary Completion Date
June 26, 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
Social Sciences and Humanities Research Council (Canada)
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
This is a retrospective registration. The study was conducted at The Ohio State University from 2011 to 2012. This study was approved by an Institutional Review Board at The Ohio State University. The investigators retroactively registered this trial to facilitate publishing results in journal that now require registration. Any reference to the study's registration will make it clear that the registration was retroactive. Cognitive behavior therapy (CBT) has been shown to be an effective treatment for depression. However, a substantial number of patients do not respond to treatment or continue to be symptomatic at its conclusion. An important goal of ongoing research is to find ways to enhance treatment outcomes. One approach to doing this is to modifying existing treatments to individualize the approach to better meet the needs of individual patients. In this study, the investigators tested two main components of CBT to empirically evaluate patient characteristics that may predict differential response to these components. By using components of CBT, any suggestions about the strategies that are best suited to different patients are likely be easily implemented by therapists providing CBT. The two treatment components the investigators examined were: cognitive interventions (e.g., challenging negative automatic thoughts) and behavioral interventions (e.g., engaging in activities to promote a sense of pleasure or accomplishment). The investigators recruited adults with major depressive disorder and randomized them to a cognitive or behavioral intervention. After 8 weeks of treatment, patients were randomized again to a cognitive or behavioral intervention. Consequently, participants were offered a total of 16 weeks of treatment. Depressive symptoms were assessed with the Beck Depression Inventory-II (BDI-II) and the Hamilton Rating Scale for Depression (HRSD), with the latter being the primary outcome measure. Several variables that might serve to predict differential response to cognitive and behavioral treatments were also assessed. The results of this study may help to elucidate how cognitive or behavioral interventions might be selected so as to enhance overall treatment outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive-only Intervention
Arm Type
Active Comparator
Arm Description
This condition includes cognitive interventions drawn from cognitive therapy as described in Beck, Rush, Shaw, & Emery (1979).
Arm Title
Behavioral-only Intervention
Arm Type
Active Comparator
Arm Description
The condition includes behavioral interventions drawn from cognitive therapy as described in Beck, Rush, Shaw, & Emery (1979).
Intervention Type
Other
Intervention Name(s)
Psychotherapy
Primary Outcome Measure Information:
Title
Change in Hamilton Rating Scale for Depression at week 8 and week 16
Description
The Hamilton Rating Scale for Depression is a 17-item interviewer evaluated assessment of depressive symptoms. Scores range from 0 to 52, with higher scores indicating greater depressive symptoms.
Time Frame
Time Frame: Weeks 0-8 and 0-16, assessments occurred at weeks 0, 4, 8, and 16.
Secondary Outcome Measure Information:
Title
Change in Beck Depression Inventory-II at week 8 and week 16
Description
The Beck Depression Inventory-II is a 21-item self-report measure of depressive symptoms. Scores range from 0 to 63, with higher scores indicating greater depressive symptoms.
Time Frame
Time Frame: Weeks 0-8 and 0-16, assessments occurred at every session through week 16.
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-IV criteria (APA, 1994)
Able and willing to give informed consent
Exclusion Criteria:
History of bipolar affective disorder or psychosis
Current Axis I disorder other than MDD if it constitutes the predominant aspect of the clinical presentation and if it requires treatment other than that being offered
History of substance dependence in the past six months
Subnormal intellectual potential (IQ below 80, testing to be initiated if clinically indicated)
Clear indication of secondary gain (e.g., court ordered treatment)
Current suicide risk or significant intentional self-harm in the last six months sufficient to preclude treatment on an outpatient basis
If clients currently being treated with a medication for depression: (1) no change in medication and a stable dose for at least 1 month prior to their initial assessment; and (2) agreeing to not make changes to medication or medication dose during the study.
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:
PubMed Identifier
34656197
Citation
Murphy ST, Cooper AA, Hollars SN, Strunk DR. Who Benefits From a Cognitive vs. Behavioral Approach to Treating Depression? A Pilot Study of Prescriptive Predictors. Behav Ther. 2021 Nov;52(6):1433-1448. doi: 10.1016/j.beth.2021.03.012. Epub 2021 Apr 9.
Results Reference
derived
Learn more about this trial
Patient Characteristics and Cognitive vs. Behavioral Therapies for Depression
We'll reach out to this number within 24 hrs