Major Depressive Disorder Clinical Trial
Official title:
A Computerized Cognitive Behavioral Therapy for Cancer Patients With Major Depressive Disorder
Verified date | June 2020 |
Source | Ohio State University Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This randomized clinical trial studies how well a computerized cognitive behavior therapy program works in treating depression in patients with cancer. The cognitive behavior therapy program uses a series of internet-delivered sessions intended to help patients identify and change problematic patterns of thinking and behavior that maintain depression.
Status | Completed |
Enrollment | 31 |
Est. completion date | March 29, 2018 |
Est. primary completion date | December 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - A current/prior cancer diagnosis - A principal diagnosis of major depressive disorder (MDD) - Able and willing to give informed consent - Have access to a computer with an internet connection at home Exclusion Criteria: - History of bipolar affective disorder or psychosis - History of substance dependence in the past six months - Subnormal intellectual potential (intelligence quotient [IQ] below 80) - Current suicide risk or significant intentional self-harm in the last six months sufficient to preclude treatment on an outpatient basis - Inability to read and write English |
Country | Name | City | State |
---|---|---|---|
United States | Ohio State University | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Ohio State University Comprehensive Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Hamilton Rating Scale for Depression (HRSD) | The 17-item HRSD, modified to assess atypical symptoms, is a standard interview-administered measure of depressive symptom severity. The HRSD will be administered by study personnel supervised by the Principal Investigator. | Week 0 to Week 8 | |
Secondary | Change in the Beck Depression Inventory (BDI-II) | The PHQ9 is a 9-item self-report measure based on the diagnostic criteria for major depression from the Diagnostic and Statistical Manual Fourth Edition (DSM-IV). | Week 0 to week 8 | |
Secondary | Change in Patient Health Questionnaire-9 (PHQ-9) | 21 item self report measures of depressive symptoms | Week 0 to week 8 | |
Secondary | Change in Generalized Anxiety Disorder-7 (GAD7) | The GAD7 is a 7-item self-report measure based on the diagnostic criteria for generalized anxiety disorder from the DSM-IV. | Week 0 to week 8 |
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