An interventional study of Psychotherapy in Major Depressive Disorder, sponsored by Ohio State University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-12.
Sponsored by Ohio State University · Not applicable, Interventional, and Treatment
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.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 42 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →Ohio State University is the lead sponsor of 640 studies on the registry; 144 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 45 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This condition includes cognitive interventions drawn from cognitive therapy as described in Beck, Rush, Shaw, \& Emery (1979).
Other: Psychotherapy
The condition includes behavioral interventions drawn from cognitive therapy as described in Beck, Rush, Shaw, \& Emery (1979).
Other: Psychotherapy
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.
Time frame: Time Frame: Weeks 0-8 and 0-16, assessments occurred at weeks 0, 4, 8, and 16.
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.
Time frame: Time Frame: Weeks 0-8 and 0-16, assessments occurred at every session through week 16.
Plan to share: No — We will consider requests for data sharing, pending approval from our IRB.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Ohio State University