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Trial record 47 of 6099 for:    "Depressive Disorder" [DISEASE]

Computerized Cognitive Behavior Therapy in Treating Depression in Patients With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02837887
Recruitment Status : Completed
First Posted : July 20, 2016
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Barbara Andersen, Ohio State University Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: Computerized Cognitive Behavior Therapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Computerized Cognitive Behavioral Therapy for Cancer Patients With Major Depressive Disorder
Study Start Date : July 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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 PHQ-9 and GAD7 at weeks 1, 3, 5, 7 and 8 and complete other questionnaires for 15-30 minutes each that assess psychosocial and physical symptoms.
Behavioral: Computerized Cognitive Behavior Therapy
Undergo computerized cognitive behavior therapy
Other Names:
  • cCBT
  • cognitive behavior therapy
  • Beating the Blues
  • CBT

Experimental: Group II (wait-list)
Patients are placed on an 8-week wait-list and then undergo computerized cognitive behavior therapy and receive questionnaires as in Group I.
Behavioral: Computerized Cognitive Behavior Therapy
Undergo computerized cognitive behavior therapy
Other Names:
  • cCBT
  • cognitive behavior therapy
  • Beating the Blues
  • CBT




Primary Outcome Measures :
  1. Change in Hamilton Rating Scale for Depression (HRSD) [ Time Frame: Week 0 to Week 8 ]
    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.


Secondary Outcome Measures :
  1. Change in the Beck Depression Inventory (BDI-II) [ Time Frame: Week 0 to week 8 ]
    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).

  2. Change in Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Week 0 to week 8 ]
    21 item self report measures of depressive symptoms

  3. Change in Generalized Anxiety Disorder-7 (GAD7) [ Time Frame: Week 0 to week 8 ]
    The GAD7 is a 7-item self-report measure based on the diagnostic criteria for generalized anxiety disorder from the DSM-IV.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837887


Locations
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United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
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Principal Investigator: Barbara Andersen, PhD Ohio State University Comprehensive Cancer Center

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Responsible Party: Barbara Andersen, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02837887     History of Changes
Other Study ID Numbers: OSU-16008
NCI-2016-00954 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018

Keywords provided by Barbara Andersen, Ohio State University Comprehensive Cancer Center:
Cancer
Depression

Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms