Computerized Cognitive Behavior Therapy in Treating Depression in Patients With Cancer

NCT ID: NCT02837887

Last Updated: 2020-06-22

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-15

Study Completion Date

2018-03-29

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.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

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.

Group Type EXPERIMENTAL

Computerized Cognitive Behavior Therapy

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

Computerized Cognitive Behavior Therapy

Intervention Type BEHAVIORAL

Undergo computerized cognitive behavior therapy

Interventions

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Computerized Cognitive Behavior Therapy

Undergo computerized cognitive behavior therapy

Intervention Type BEHAVIORAL

Other Intervention Names

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cCBT cognitive behavior therapy Beating the Blues CBT

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Barbara Andersen

Principal Investigator

Responsibility Role 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

Site Status

Countries

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United States

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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