Computerized Cognitive Behavior Therapy in Treating Depression in Patients With Cancer

Major Depressive Disorder Clinical Trial

Official title:

A Computerized Cognitive Behavioral Therapy for Cancer Patients With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02837887
• Other study ID #: OSU-16008
• Secondary ID: NCI-2016-00954
• Status: Completed
• Phase: N/A
• Start date: July 15, 2016
• Est. completion date: March 29, 2018

Study information

• Verified date: June 2020
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 29, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Behavioral:
• Computerized Cognitive Behavior Therapy
Undergo computerized cognitive behavior therapy

Locations

Country	Name	City	State
United States	Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hamilton Rating Scale for Depression (HRSD)	The 17-item HRSD, modified to assess atypical symptoms, is a standard interview-administered measure of depressive symptom severity. The HRSD will be administered by study personnel supervised by the Principal Investigator.	Week 0 to Week 8
Secondary	Change in the Beck Depression Inventory (BDI-II)	The PHQ9 is a 9-item self-report measure based on the diagnostic criteria for major depression from the Diagnostic and Statistical Manual Fourth Edition (DSM-IV).	Week 0 to week 8
Secondary	Change in Patient Health Questionnaire-9 (PHQ-9)	21 item self report measures of depressive symptoms	Week 0 to week 8
Secondary	Change in Generalized Anxiety Disorder-7 (GAD7)	The GAD7 is a 7-item self-report measure based on the diagnostic criteria for generalized anxiety disorder from the DSM-IV.	Week 0 to week 8