Cognitive Therapy in Reducing Depression in Patients With Cancer

NCT ID: NCT01748734

Last Updated: 2015-06-04

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

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Brief Summary

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The purpose of this study is to learn about treatment of depression in people who have any type of cancer. Cognitive therapy (CT) helps improve depressive symptoms by targeting patient's thoughts and behaviors. People who are depressed tend to have more negative or pessimistic thoughts. CT helps people evaluate the accuracy of their thoughts. By encouraging patients to develop more balanced views, symptoms of depression begin to improve

Detailed Description

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PRIMARY OBJECTIVES:

I. Determine the efficacy of biobehavioral/cognitive therapy for cancer patients/survivors with major depression.

II. Test for the covariation between reduction in depressive symptoms and improvements in quality of life.

OUTLINE:

Patients undergo cognitive behavioral therapy comprising progressive muscle relaxation training, behavioral activation, seeking information as a coping strategy, enhancing social support, cognitive reappraisal, assertive communication, changing depressive core beliefs, goal setting and planning for maintenance, and maintenance over 1 hour once weekly sessions for 12-20 weeks, biweekly sessions for 4-6 weeks, and monthly sessions for 2-3 months for a total of 16-26 sessions.

After completion of study treatment, patients are followed up at 3, 6, and 12 months.

Conditions

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Depression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Supportive care (cognitive behavioral therapy)

Cognitive behavioral therapy comprising progressive muscle relaxation training, behavioral activation, seeking information as a coping strategy, enhancing social support, cognitive reappraisal, assertive communication, changing depressive core beliefs, goal setting and planning for maintenance, and maintenance over 1 hour once weekly sessions for 12-20 weeks, biweekly sessions for 4-6 weeks, and monthly sessions for 2-3 months for a total of 16-26 sessions.

Group Type EXPERIMENTAL

quality-of-life assessment

Intervention Type PROCEDURE

Ancillary studies

questionnaire administration

Intervention Type OTHER

Ancillary studies

counseling intervention

Intervention Type OTHER

Undergo cognitive behavioral therapy

behavioral intervention

Intervention Type BEHAVIORAL

Undergo cognitive behavioral therapy

Interventions

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quality-of-life assessment

Ancillary studies

Intervention Type PROCEDURE

questionnaire administration

Ancillary studies

Intervention Type OTHER

counseling intervention

Undergo cognitive behavioral therapy

Intervention Type OTHER

behavioral intervention

Undergo cognitive behavioral therapy

Intervention Type BEHAVIORAL

Other Intervention Names

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quality of life assessment counseling and communications studies Behavior Conditioning Therapy Behavior Therapy Behavioral Modification Behavioral Therapy Behavioral Treatment

Eligibility Criteria

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Inclusion Criteria

* Prior diagnosis of invasive cancer, any site, any stage, any time since diagnosis; history of non malignant (basal cell) or low malignant potential (e.g., in situ cervix) cancers do not meet this criterion
* Diagnosis of major depressive disorder (MDD), according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria (American Psychiatric Association, 2000)
* Able and willing to give informed consent

Exclusion Criteria

* History of bipolar affective disorder or psychosis
* Current axis I disorder (e.g. obsessive-compulsive disorder, specific phobia) other than MDD if it constitutes the predominant aspect of the clinical presentation and if it requires treatment other than that being offered
* History of substance dependence in the past six months
* Subnormal intellectual potential (intelligence quotient \[IQ\] below 80)
* Current suicide risk sufficient to preclude treatment on an outpatient basis
* Progressive neurological or related conditions/diagnoses
* Non-ambulatory
* Life expectancy less than 60 days
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 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, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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Ohio State University Medical Center

Columbus, Ohio, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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NCI-2012-00738

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-07043

Identifier Type: -

Identifier Source: org_study_id

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