Computerized Cognitive Behavior Therapy in Treating Depression in Patients With Cancer
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized Cognitive Behavior Therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Major Depressive Disorder focused on measuring Cancer, Depression
Eligibility Criteria
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
Sites / Locations
- Ohio State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group I (immediate treatment)
Group II (wait-list)
Arm Description
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.
Patients are placed on an 8-week wait-list and then undergo computerized cognitive behavior therapy and receive questionnaires as in Group I.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Change in Patient Health Questionnaire-9 (PHQ-9)
21 item self report measures of depressive symptoms
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.
Full Information
NCT ID
NCT02837887
First Posted
July 13, 2016
Last Updated
June 18, 2020
Sponsor
Ohio State University Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT02837887
Brief Title
Computerized Cognitive Behavior Therapy in Treating Depression in Patients With Cancer
Official Title
A Computerized Cognitive Behavioral Therapy for Cancer Patients With Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
July 15, 2016 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
March 29, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
PRIMARY OBJECTIVES:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Cancer, Depression
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I (immediate treatment)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group II (wait-list)
Arm Type
Experimental
Arm Description
Patients are placed on an 8-week wait-list and then undergo computerized cognitive behavior therapy and receive questionnaires as in Group I.
Intervention Type
Behavioral
Intervention Name(s)
Computerized Cognitive Behavior Therapy
Other Intervention Name(s)
cCBT, cognitive behavior therapy, Beating the Blues, CBT
Intervention Description
Undergo computerized cognitive behavior therapy
Primary Outcome Measure Information:
Title
Change in Hamilton Rating Scale for Depression (HRSD)
Description
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.
Time Frame
Week 0 to Week 8
Secondary Outcome Measure Information:
Title
Change in the Beck Depression Inventory (BDI-II)
Description
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).
Time Frame
Week 0 to week 8
Title
Change in Patient Health Questionnaire-9 (PHQ-9)
Description
21 item self report measures of depressive symptoms
Time Frame
Week 0 to week 8
Title
Change in Generalized Anxiety Disorder-7 (GAD7)
Description
The GAD7 is a 7-item self-report measure based on the diagnostic criteria for generalized anxiety disorder from the DSM-IV.
Time Frame
Week 0 to week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Andersen, PhD
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Computerized Cognitive Behavior Therapy in Treating Depression in Patients With Cancer
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