Computerized Cognitive Behavior Therapy in Treating Depression in Patients With Cancer
NCT ID: NCT02837887
Last Updated: 2020-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
31 participants
INTERVENTIONAL
2016-07-15
2018-03-29
Brief Summary
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Detailed Description
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I. Establish the efficacy of computerized cognitive behavior therapy ("Beating the Blues") in reducing symptoms of depression and remission of major depressive disorder (MDD) in cancer patients.
II. Test the feasibility of implementation and patient acceptability of online computerized cognitive behavior therapy for cancer patients with major depressive disorder (MDD).
III. Test moderators (cancer specific stress, MDD history, anxiety disorder comorbidity, and homework compliance) of treatment outcome.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I (IMMEDIATE TREATMENT): Patients undergo computerized cognitive behavior therapy consisting of 45-60 minute sessions once per week for 8 weeks. Patients also complete the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD7) at weeks 1, 3, 5, 7 and 8 and complete other questionnaires for 15-30 minutes each that assess psychosocial and physical symptoms.
GROUP II (WAIT-LIST): Patients are placed on an 8-week wait-list and then undergo computerized behavior therapy and receive questionnaires as in Group I.
After completion of study intervention, patients are followed up at 2, 4, and 6 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Group I (immediate treatment)
Patients undergo computerized cognitive behavior therapy consisting of 45-60 minute sessions once per week for 8 weeks. Patients also complete the PHQ-9 and GAD7 at weeks 1, 3, 5, 7 and 8 and complete other questionnaires for 15-30 minutes each that assess psychosocial and physical symptoms.
Computerized Cognitive Behavior Therapy
Undergo computerized cognitive behavior therapy
Group II (wait-list)
Patients are placed on an 8-week wait-list and then undergo computerized cognitive behavior therapy and receive questionnaires as in Group I.
Computerized Cognitive Behavior Therapy
Undergo computerized cognitive behavior therapy
Interventions
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Computerized Cognitive Behavior Therapy
Undergo computerized cognitive behavior therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Barbara Andersen
Principal Investigator
Principal Investigators
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Barbara Andersen, PhD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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Ohio State University
Columbus, Ohio, United States
Countries
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Other Identifiers
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NCI-2016-00954
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-16008
Identifier Type: -
Identifier Source: org_study_id
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