A Computerized Cognitive Behavioral Therapy for Cancer Patients With Major Depressive Disorder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Change in Hamilton Rating Scale for Depression (HRSD)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Computerized Cognitive Behavior Therapy (Behavioral)
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.
Intervention: Computerized Cognitive Behavior Therapy (Behavioral)
Outcomes
Primary Outcomes
Change in Hamilton Rating Scale for Depression (HRSD)
Time Frame: Week 0 to Week 8
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 Outcomes
- Change in the Beck Depression Inventory (BDI-II)(Week 0 to week 8)
- Change in Patient Health Questionnaire-9 (PHQ-9)(Week 0 to week 8)
- Change in Generalized Anxiety Disorder-7 (GAD7)(Week 0 to week 8)
Investigators
Barbara Andersen
Principal Investigator
Ohio State University Comprehensive Cancer Center