Pilot Study Assessing Computerized Cognitive Behavioral Therapy for Depression

NCT01990053 | Completed

• 1 other identifier: 2013B0307
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

Standard treatments for depression in specialty care settings are effective but resources for delivering empirically supported psychotherapies are often limited. Computerized cognitive behavioral therapy (cCBT) is an effective and highly scalable treatment for depression that might help expand services in psychiatric settings, however, little is known about its efficacy in this population. The present study aims to establish the efficacy of a internet-delivered cCBT program ("Beating the Blues") plus email and telephone support for depression in a psychiatric outpatient clinic setting. The secondary aim is to pilot an assessment procedure designed to identify moderators of treatment effectiveness.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Hamilton Rating Scale for Depression (HRSD) from 0 to 8 weeks

  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, week 8

Secondary Outcomes (1)

• Change in Patient Health Questionnaire-9 (PHQ9) over 8 weeks

  weeks 0-8

Other Outcomes (2)

• Change in Generalized Anxiety Disorder-7 (GAD7) over 8 weeks

  weeks 0-8

• Change in Depression Anxiety and Stress Scale-21 (DASS21) over 8 weeks

  week 0, week 8

Study Arms (2)

Beating the Blues

EXPERIMENTAL

Beating the Blues plus helper support.

Behavioral: Beating the Blues

Waitlist Condition

NO INTERVENTION

Eight week waitlist condition group parallel to the immediate treatment condition with optional entrance into the Beating the Blues after the first eight weeks

Interventions

Beating the Blues BEHAVIORAL

The BtB program guides patients through a series of 8 fully automated online lessons intended to help them identify and change problematic patterns of thinking and behavior that maintain depression. Support will be provided by licensed professional therapists over the phone or via email.

Also known as: Beating the Blues (BtB)

Beating the Blues

Eligibility Criteria

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

You may qualify if:

• Diagnosis of Major Depressive Disorder (MDD) according to Diagnostic and Statistical Manual Fourth Edition criteria
• 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
• Current Axis I disorder other than MDD if it constitutes the predominate aspect of the clinical presentation and if it requires treatment other than that being offered
• History of substance dependence in the past six months
• Subnormal intellectual potential (IQ below 80)
• Clear indication of secondary gain (e.g., court ordered treatment or compensation issues)
• Current suicide risk or significant intentional self-harm in the last six months sufficient to preclude treatment on an outpatient basis
• Discharge within six moths from a higher level of care (inpatient, partial hospital, or intensive outpatient treatment)
• Currently undergoing outpatient psychotherapy
• Current antidepressant medication treatment if the individual has had a change in medication over the past month or is planning a change in medication during the duration of the study
• Inability to read and write English

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Daniel R Strunk, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: November 21, 2013
• Study Start: April 14, 2014
• Primary Completion: May 3, 2016
• Study Completion: May 1, 2017
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

US (1)