Cognitive Therapy in Reducing Depression in Patients With Cancer

The Ohio State University

Status and phase: Completed; Phase 2

Conditions: Depression

Treatments: Other: questionnaire administration; Procedure: quality-of-life assessment; Behavioral: behavioral intervention; Other: counseling intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01748734

NCI-2012-00738 (Registry Identifier)

OSU-07043

Details and patient eligibility

About

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

Full description

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Supportive care (cognitive behavioral therapy)

Experimental group

Description:

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.

Treatment:

Behavioral: behavioral intervention

Other: counseling intervention

Procedure: quality-of-life assessment

Other: questionnaire administration