Major Depressive DisorderNCT04529694
Patient Characteristics and Cognitive vs. Behavioral Therapies for Depression
A study testing Psychotherapy in people with Major Depressive Disorder, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Psychotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2011to 26 Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of major depressive disorder (MDD) according to DSM-IV criteria (APA, 1994)
- Able and willing to give informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Psychology, The Ohio State University
Columbus, Ohio, 43210
About this study
Official title: 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Psychotherapy
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyOther
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-only Intervention | Active comparator | This condition includes cognitive interventions drawn from cognitive therapy as described in Beck, Rush, Shaw, \& Emery (1979). Receives: Other: Psychotherapy |
| Behavioral-only Intervention | Active comparator | The condition includes behavioral interventions drawn from cognitive therapy as described in Beck, Rush, Shaw, \& Emery (1979). Receives: Other: Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Time Frame: Weeks 0-8 and 0-16, assessments occurred at weeks 0, 4, 8, and 16.
Secondary outcomes (1)
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.
Measured: Time Frame: Weeks 0-8 and 0-16, assessments occurred at every session through week 16.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start20 Oct 2011
- Primary completion26 Jun 2012
- Study completion26 Jun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Social Sciences and Humanities Research Council of Canada
- Responsible party
- Principal investigator, Daniel R. Strunk, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04529694
- Sponsor's protocol ID
- 2011B0342
- Status last verified
- Jun 2024
- First submitted
- 14 Aug 2020
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will consider requests for data sharing, pending approval from our IRB.
Publications
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.
PubMed 34656197
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Characteristics and Cognitive Behavior Therapy for Depression
- ClinicalTrials.gov ID
- NCT04529694
- Acronym / sponsor ID
- 2011B0342
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Social Sciences and Humanities Research Council of Canada
- Study start
- 20 Oct 2011 (actual)
- Primary completion
- 26 Jun 2012 (actual)
- Study completion
- 26 Jun 2012 (actual)
- First posted
- 28 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive-only Intervention | Active comparator | Other: PsychotherapyThis condition includes cognitive interventions drawn from cognitive therapy as described in Beck, Rush, Shaw, \& Emery (1979). |
| Behavioral-only Intervention | Active comparator | Other: PsychotherapyThe condition includes behavioral interventions drawn from cognitive therapy as described in Beck, Rush, Shaw, \& Emery (1979). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of major depressive disorder (MDD) according to DSM-IV criteria (APA, 1994)
- Able and willing to give informed consent
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychotherapy | Other | Behavioral-only Intervention, Cognitive-only Intervention |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Derived from this study: PubMed 34656197Murphy 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.
- Individual participant dataSharing planned: No. We will consider requests for data sharing, pending approval from our IRB.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy in people with Major Depressive Disorder, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04529694, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.