An Examination of Cognitive Therapy for Depression in Cancer Patients.
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.
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Psychiatric diagnoses, using the Structured Clinical Interview for the DSM-IV (SCID)
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.
Up to 12 months
Barbara Andersen, Ph.D.
Ohio State University
United States: Institutional Review Board
|Ohio State University Medical Center||Columbus, Ohio 43210|