- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04529694
Patient Characteristics and Cognitive vs. Behavioral Therapies for Depression
August 24, 2020 updated by: Daniel R. Strunk, Ohio State University
PATIENT CHARACTERISTICS AND COGNITIVE BEHAVIOR THERAPY FOR DEPRESSION
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Department of Psychology, The Ohio State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Cognitive-only Intervention
This condition includes cognitive interventions drawn from cognitive therapy as described in Beck, Rush, Shaw, & Emery (1979).
|
|
Active Comparator: Behavioral-only Intervention
The condition includes behavioral interventions drawn from cognitive therapy as described in Beck, Rush, Shaw, & Emery (1979).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Hamilton Rating Scale for Depression at week 8 and week 16
Time Frame: Time Frame: Weeks 0-8 and 0-16, assessments occurred at weeks 0, 4, 8, and 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.
|
Time Frame: Weeks 0-8 and 0-16, assessments occurred at weeks 0, 4, 8, and 16.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Beck Depression Inventory-II at week 8 and week 16
Time Frame: Time Frame: Weeks 0-8 and 0-16, assessments occurred at every session through 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.
|
Time Frame: Weeks 0-8 and 0-16, assessments occurred at every session through week 16.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 20, 2011
Primary Completion (Actual)
June 26, 2012
Study Registration Dates
First Submitted
August 14, 2020
First Submitted That Met QC Criteria
August 24, 2020
First Posted (Actual)
August 28, 2020
Study Record Updates
Last Update Posted (Actual)
August 28, 2020
Last Update Submitted That Met QC Criteria
August 24, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011B0342
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
We will consider requests for data sharing, pending approval from our IRB.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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