Clinical trial NCT01748734: Cognitive Therapy in Reducing Depression in Patients With Cancer
Official title: An Examination of Cognitive Therapy for Depression in Cancer Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depression
Keywords: Depression
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2012-12-12
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Psychiatric diagnoses, using the Structured Clinical Interview for the DSM-IV (SCID)
timeFrame: Up to 12 months
measure: Hamilton Rating Scale for Depression (HRSC) as a measure of depressive symptom severity
timeFrame: Up to 12 months
measure: Beck Depression Inventory - 2nd Edition (BDI-II) used to assess the severity of symptoms of depression
timeFrame: Up to 12 months
Secondary outcomes:
measure: Stress, as measured by the life events scale and the cancer-related Impact of Events Scale (IES)
timeFrame: Up to 12 months
measure: 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)
timeFrame: Up to 12 months
measure: 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)
timeFrame: Up to 12 months
measure: 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)
timeFrame: Up to 12 months
measure: 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
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Barbara Andersen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: