Computerized Cognitive Behavior Therapy in Treating Depression in Patients With Cancer

NCT02837887 | Completed

• 2 other identifiers: OSU-16008NCI-2016-00954
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Cancer; Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in the Beck Depression Inventory (BDI-II)

  Week 0 to week 8

• Change in Patient Health Questionnaire-9 (PHQ-9)

  Week 0 to week 8

• Change in Generalized Anxiety Disorder-7 (GAD7)

  Week 0 to week 8

Study Arms (2)

Group I (immediate treatment)

EXPERIMENTAL

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

Group II (wait-list)

EXPERIMENTAL

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

Interventions

Computerized Cognitive Behavior Therapy BEHAVIORAL

Undergo computerized cognitive behavior therapy

Also known as: cCBT, cognitive behavior therapy, Beating the Blues, CBT

Group I (immediate treatment); Group II (wait-list)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Neoplasms; Depression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Barbara Andersen, PhD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 13, 2016
• First Posted: July 20, 2016
• Study Start: July 15, 2016
• Primary Completion: December 31, 2017
• Study Completion: March 29, 2018
• Last Updated: June 22, 2020

Record last verified: 2020-06

Locations

US (1)