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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
25
Ancillary studies
Ancillary studies
Undergo cognitive behavioral therapy
Ohio State University Medical Center
Columbus, Ohio, United States
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.
Time frame: Up to 12 months
Hamilton Rating Scale for Depression (HRSC) as a measure of depressive symptom severity
The modified 17-item HRSD interview codes both responses and behavior. Complete remission of depressive symptoms is indicated by scores of 7 or less, partial remission by scores 8-12, and no remission by scores of 13 or greater. Alpha level will be set at 0.05, beta at 0.20. 95% confidence intervals will be obtained for all outcome measures.
Time frame: Up to 12 months
Beck Depression Inventory - 2nd Edition (BDI-II) used to assess the severity of symptoms of depression
The BDI-II is a 21-item self-report instrument. Respondents describe their feelings during the past week by rating each item on a scale from 0-3. Thus, possible scores are 0 (minimal depression) to 63 (high depression). Complete remission is indicated by scores of 9 or less, partial remission by scores of 10-16, and no remission by scores of 17 or greater. Alpha level will be set at 0.05, beta at 0.20. 95% confidence intervals will be obtained for all outcome measures.
Time frame: Up to 12 months
Stress, as measured by the life events scale and the cancer-related Impact of Events Scale (IES)
Life events scale, patients indicate experience of any of 5 stressful life events during the previous year and rate how emotionally upsetting the event was. Scores calculated for presence of each event (0-1), total number of events (0-5), and sum of the distress ratings (0-15). The IES is a 22-item self report questionnaire to assess reactions to cancer diagnosis and treatment. It measures frequency of intrusive thoughts, avoidant thoughts/behaviors, and hyperarousal during the previous week using a 4-point Likert scale. Items summed for total scores ranging from 0-75.
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Undergo cognitive behavioral therapy
Time frame: Up to 12 months
Distress, as measured by the Profile of Mood States (POMS), Center for Epidemiological Studies Depression Scale (CES-D) Iowa short form, and the Beck Hopelessness Scale (HS)
POMS is a 65-item self report inventory yielding a total mood disturbance scale and 6 mood subscales on a 5-point Likert scale. Total score is sum of subscale scores and ranges from -32 to 200. CES-D is an 11-item form rated on a 3-point Likert scale. All items are summed with total scores ranging from 0 to 22. HS is a 20-item true-false form with scores ranging from 0 to 20. Alpha level will be set at 0.05, beta at 0.20. 95% confidence intervals will be obtained for all outcome measures.
Time frame: Up to 12 months
Quality of life, as measured by Medical Outcomes Study Short Form, Meaning in Life Scale (MiL), Satisfaction with Life Scale (SWLS), Fatigue Symptom Inventory-Revised (FSI), Brief Pain Questionnaire (BPQ), and Charlson Comorbidity Index (CCI)
Medical Outcomes Study Short Form is 36-item scale with 8 subscales with scores ranging 0-100. MiL is 21-item scale with 4 dimensions; subscale scores range from 1 to 6 and summary scores range from 3 to 17. SWLS is a 5-item scale measured on a 7-point scale for total scores ranging from 5 to 35. FSI is a 14-item measure with scores ranging from 0 to 70. BPI has scales with ratings from 0 to 10. CCI has total scores ranging from 0 to 37 (age unadjusted) or 0 to 43 (age adjusted). Alpha level will be set at 0.05, beta at 0.20. 95% confidence intervals will be obtained for all outcome measures.
Time frame: Up to 12 months
Social relationships, as measured by a single item from the Dyadic Adjustment Scale (DAS), a short form of the Sexual Experience Scale, and the Perceived Social Support From Friends (PSS-Fr) and Family (PSS-Fa)
DAS subscale for Affectional Expression used, rates overall relationship happiness from 0-6. Short form of the Sexual Experience Scale includes 3 items rated on a 9-point frequency scale. PSS-Fr and PSS-Fa are two 20-item instruments with total scores ranging from 0 to 20 for both scales. Alpha level will be set at 0.05, beta at 0.20. 95% confidence intervals will be obtained for all outcome measures.
Time frame: Up to 12 months
Therapy process & therapy mediators measured by Working Alliance Inventory (WAI), Expectations for Therapy, Attributional Style, COPE, Implicit Self-Relevant Beliefs Assessment (ISRBA), Ways of Responding (WOR), & Evaluation of Topics of the Intervention
WAI short assesses trust, confidence, and understanding and commitment to completing homework. Expectations for Therapy assesses expectations with regards to efficacy, type, and response. Attributional Style measures optimism. Brief COPE is a 28-item scale with 14 subscales; score ranges are 0 to 6. ISRBA is a computer-based assessment measuring valence of implicit self-relevant beliefs. WOR scale measures compensatory skills thought to be acquired in cognitive therapy for depression. Evaluation of Topics of the Intervention is an 11-item scale rating each component on a 4-point Likert scale.
Time frame: Up to 12 months