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An Examination of Cognitive Therapy for Depression in Cancer Patients.


Phase 2
18 Years
80 Years
Not Enrolling
Both
Depression

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Trial Information

An Examination of Cognitive Therapy for Depression in Cancer Patients.


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Psychiatric diagnoses, using the Structured Clinical Interview for the DSM-IV (SCID)

Outcome Description:

Only modules for mood disorders, anxiety disorders, and substance use disorders will be used. The Global Assessment of Functioning (GAF) Scale will be included as part of the SCID interview. The Longitudinal Interview Follow-Up Evaluation (LIFE) will be used to assess psychosocial, diagnostic, and treatment information. Alpha level will be set at 0.05, beta at 0.20. 95% confidence intervals will be obtained for all outcome measures.

Outcome Time Frame:

Up to 12 months

Safety Issue:

No

Principal Investigator

Barbara Andersen, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University

Authority:

United States: Institutional Review Board

Study ID:

OSU-07043

NCT ID:

NCT01748734

Start Date:

March 2011

Completion Date:

Related Keywords:

  • Depression
  • Depression
  • Depression
  • Depressive Disorder

Name

Location
Ohio State University Medical Center Columbus, Ohio  43210