Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2026-01-08 @ 3:02 AM
Study NCT ID:
NCT01748734
Status:
COMPLETED
Last Update Posted:
2015-06-04
First Post:
2012-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Therapy in Reducing Depression in Patients With Cancer
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
An Examination of Cognitive Therapy for Depression in Cancer Patients.
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to learn about treatment of depression in people who have any type of cancer. Cognitive therapy (CT) helps improve depressive symptoms by targeting patient's thoughts and behaviors. People who are depressed tend to have more negative or pessimistic thoughts. CT helps people evaluate the accuracy of their thoughts. By encouraging patients to develop more balanced views, symptoms of depression begin to improve
Detailed Description:
PRIMARY OBJECTIVES:
I. Determine the efficacy of biobehavioral/cognitive therapy for cancer patients/survivors with major depression.
II. Test for the covariation between reduction in depressive symptoms and improvements in quality of life.
OUTLINE:
Patients undergo cognitive behavioral therapy comprising progressive muscle relaxation training, behavioral activation, seeking information as a coping strategy, enhancing social support, cognitive reappraisal, assertive communication, changing depressive core beliefs, goal setting and planning for maintenance, and maintenance over 1 hour once weekly sessions for 12-20 weeks, biweekly sessions for 4-6 weeks, and monthly sessions for 2-3 months for a total of 16-26 sessions.
After completion of study treatment, patients are followed up at 3, 6, and 12 months.
I. Determine the efficacy of biobehavioral/cognitive therapy for cancer patients/survivors with major depression.
II. Test for the covariation between reduction in depressive symptoms and improvements in quality of life.
OUTLINE:
Patients undergo cognitive behavioral therapy comprising progressive muscle relaxation training, behavioral activation, seeking information as a coping strategy, enhancing social support, cognitive reappraisal, assertive communication, changing depressive core beliefs, goal setting and planning for maintenance, and maintenance over 1 hour once weekly sessions for 12-20 weeks, biweekly sessions for 4-6 weeks, and monthly sessions for 2-3 months for a total of 16-26 sessions.
After completion of study treatment, patients are followed up at 3, 6, and 12 months.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2012-00738 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |