Computerized Cognitive Behavior Therapy in Treating Depression in Patients With Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Computerized Cognitive Behavioral Therapy for Cancer Patients With Major Depressive Disorder

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Behavioral: Computerized Cognitive Behavior Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (immediate treatment)<br>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. | Behavioral: Computerized Cognitive Behavior Therapy<br>* Undergo computerized cognitive behavior therapy<br>* Other names: CBT;|
| Experimental: Group II (wait-list)<br>Patients are placed on an 8-week wait-list and then undergo computerized cognitive behavior therapy and receive questionnaires as in Group I. | Behavioral: Computerized Cognitive Behavior Therapy<br>* Undergo computerized cognitive behavior therapy<br>* Other names: CBT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change in Patient Health Questionnaire-9 (PHQ-9) | 21 item self report measures of depressive symptoms | Week 0 to week 8 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Depression