Clinical trial NCT02837887: Computerized Cognitive Behavior Therapy in Treating Depression in Patients With Cancer
Official title: A Computerized Cognitive Behavioral Therapy for Cancer Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Cancer
Depression
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2016-07-20
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized clinical trial studies how well a computerized cognitive behavior therapy program works in treating depression in patients with cancer. The cognitive behavior therapy program uses a series of internet-delivered sessions intended to help patients identify and change problematic patterns of thinking and behavior that maintain depression.

Detailed description: PRIMARY OBJECTIVES:

I. Establish the efficacy of computerized cognitive behavior therapy ("Beating the Blues") in reducing symptoms of depression and remission of major depressive disorder (MDD) in cancer patients.

II. Test the feasibility of implementation and patient acceptability of online computerized cognitive behavior therapy for cancer patients with major depressive disorder (MDD).

III. Test moderators (cancer specific stress, MDD history, anxiety disorder comorbidity, and homework compliance) of treatment outcome.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I (IMMEDIATE TREATMENT): Patients undergo computerized cognitive behavior therapy consisting of 45-60 minute sessions once per week for 8 weeks. Patients also complete the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD7) at weeks 1, 3, 5, 7 and 8 and complete other questionnaires for 15-30 minutes each that assess psychosocial and physical symptoms.

GROUP II (WAIT-LIST): Patients are placed on an 8-week wait-list and then undergo computerized behavior therapy and receive questionnaires as in Group I.

After completion of study intervention, patients are followed up at 2, 4, and 6 months.

Eligibility criteria: Inclusion Criteria:

* A current/prior cancer diagnosis
* A principal diagnosis of major depressive disorder (MDD)
* Able and willing to give informed consent
* Have access to a computer with an internet connection at home

Exclusion Criteria:

* History of bipolar affective disorder or psychosis
* History of substance dependence in the past six months
* Subnormal intellectual potential (intelligence quotient \[IQ\] below 80)
* Current suicide risk or significant intentional self-harm in the last six months sufficient to preclude treatment on an outpatient basis
* Inability to read and write English

Primary outcomes:
measure: Change in Hamilton Rating Scale for Depression (HRSD)
timeFrame: Week 0 to Week 8
Secondary outcomes:
measure: Change in the Beck Depression Inventory (BDI-II)
timeFrame: Week 0 to week 8
measure: Change in Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Week 0 to week 8
measure: Change in Generalized Anxiety Disorder-7 (GAD7)
timeFrame: Week 0 to week 8
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Barbara Andersen, PhD
role: PRINCIPAL_INVESTIGATOR
References: