NCT02700009

Brief Summary

Computer-assisted cognitive-behavior therapy, a treatment that has been shown to be effective in previous studies in psychiatric settings, will be disseminated into primary care - a health care setting where there are significant problems in receiving adequate treatment for depression. Computer-assisted cognitive-behavior therapy will feature a low-cost method of delivering therapy designed to be replicated and sustained in other primary care settings. Feasibility and effectiveness will be tested by randomly assigning 320 primary care patients with depression to receive either computer-assisted cognitive-behavior therapy or treatment as usual.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 7, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

4.6 years

First QC Date

February 25, 2016

Last Update Submit

March 12, 2025

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

  • Patient Health Questionnaire - 9

    Self-report scale for depression

    Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment period ends

Secondary Outcomes (6)

  • Automatic Thoughts Questionnaire

    Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment period ends

  • Quality of Life Enjoyment and Satisfaction Questionnaire

    Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment period ends

  • Client Service Receipt Inventory

    Change from baseline after 12 weeks of treatment and 3 and 6 months after 12-week treatment ends

  • Quality of Well Being Scale

    Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment periods ends

  • Patient Attitudes and Expectations Scale

    Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment periods ends

  • +1 more secondary outcomes

Study Arms (2)

Computer-assisted CBT (CCBT)

EXPERIMENTAL

12 weeks of CCBT for depression

Behavioral: Computer-assisted CBT (CCBT)

Treatment as Usual (TAU)

ACTIVE COMPARATOR

Treatment as usual by primary care physicians

Other: Treatment as Usual (TAU)

Interventions

Computer-assisted CBT (CCBT)BEHAVIORAL

Computer-assisted psychotherapy for depression using a computer program plus clinician support

Computer-assisted CBT (CCBT)
Treatment as Usual (TAU)OTHER

Ordinary treatment for depression in primary care setting

Treatment as Usual (TAU)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient Health Questionnaire score of 10 or above
  • Age 18 or above

You may not qualify if:

  • Refusal to provide informed consent
  • Inability to read English text on computer screen
  • Significant suicidal thoughts, intent, plan, or behavior reported on Columbia Suicide Severity Rating Scale
  • Severe or poorly controlled medical disorders that would interfere with participation in CCBT (e.g., liver failure, terminal cancer)
  • Dementia or other organic brain disorders that would prevent participation in CCBT
  • Diagnosis of any psychotic disorder or bipolar disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Louisville, School of Medicine

Louisville, Kentucky, 40202, United States

Location

Related Publications (1)

  • Wright JH, Owen J, Eells TD, Antle B, Bishop LB, Girdler R, Harris LM, Wright RB, Wells MJ, Gopalraj R, Pendleton ME, Ali S. Effect of Computer-Assisted Cognitive Behavior Therapy vs Usual Care on Depression Among Adults in Primary Care: A Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e2146716. doi: 10.1001/jamanetworkopen.2021.46716.

    PMID: 35142833DERIVED

MeSH Terms

Conditions

Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Jesse Wright, M.D., Ph.D.

    University of Louisville

    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
Professor

Study Record Dates

First Submitted

February 25, 2016

First Posted

March 7, 2016

Study Start

May 1, 2016

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

March 17, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)