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Completed

NCT Number: NCT02837887

Computerized Cognitive Behavior Therapy in Treating Depression in Patients With Cancer

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.

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computerized Cognitive Behavior Therapy

Behavioral

Undergo computerized cognitive behavior therapy

Other names: cCBT, cognitive behavior therapy, Beating the Blues, CBT

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jul 20, 2016
Registry last updated
Jun 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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