Computerized Cognitive Behavior Therapy in Treating Depression in Patients With Cancer

The Ohio State University

Status: Completed

Conditions: Major Depressive Disorder

Treatments: Behavioral: Computerized Cognitive Behavior Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02837887

NCI-2016-00954 (Registry Identifier)

OSU-16008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Group I (immediate treatment)

Experimental group

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.

Treatment:

Behavioral: Computerized Cognitive Behavior Therapy

Group II (wait-list)

Experimental group

Description:

Patients are placed on an 8-week wait-list and then undergo computerized cognitive behavior therapy and receive questionnaires as in Group I.

Treatment:

Behavioral: Computerized Cognitive Behavior Therapy