DepressionNCT02700009
Computer-assisted Cognitive-Behavior Therapy for Depression in Primary Care
A study testing Computer-assisted CBT (CCBT) and Treatment as Usual (TAU) in people with Depression, run by University of Louisville at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Computer-assisted CBT (CCBT) and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient Health Questionnaire score of 10 or above
- Age 18 or above
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville, School of Medicine
Louisville, Kentucky, 40202
About this study
Official title: Dissemination of Computer-assisted Cognitive-behavior Therapy for Depression in Primary Care
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.
Read the detailed description
Computer-assisted cognitive-behavior therapy (CCBT) for depression in primary care will be evaluated in a trial with 320 patients randomly assigned to CCBT or treatment as usual (TAU). The study will disseminate a therapy method found to be effective in psychiatric settings into primary care - a setting where there have been significant problems in delivery of adequate, evidence-based treatment for depression. The study will include a high percentage of disadvantaged patients - a population that has been largely ignored in previous research in CCBT. There have been no previous studies of CCBT for depression in primary care that have enrolled large numbers of disadvantaged patients. The form of CCBT used in this study is designed to increase access to effective therapy, provide a cost-effective method, and be a sustainable model for wide-spread use in primary care.
In order to deliver therapy in a practical manner that can be replicated in other primary care practices, patients with significant symptoms of depression will receive treatment with an empirically supported computer program that builds cognitive-behavior therapy skills. Support for CCBT will be provided by telephone and/or e-mail contact with a care coordinator instead of the face-to-face treatment with a cognitive-behavior therapist that has been a part of CCBT delivery in mental health settings. Novel features of this treatment program include: 1) fully detailed and replicable method for integrating clinician support with CCBT in primary care; 2) delivery of CCBT to a population with high percentage of disadvantaged patients; 3) integration of CCBT into the primary care delivery model; 4) highly interactive, multimedia computer program with adaptations for persons who may have lower levels of education or computer experience; 5) advanced cost-benefit analysis including data on actual health care utilization and costs; 6) exploration of moderators and predictors of treatment outcome.
Outcome will be assessed by measuring CCBT completion rate, comprehension of CBT concepts, and satisfaction with treatment; in addition to ratings of depressive symptoms, negative thoughts, and quality of life. The cost-effectiveness analysis and exploration of possible predictors of outcome should help clinicians, health care organizations, and others plan further dissemination of CCBT in primary care.
- Conditions
- Depression
- Being tested
- Computer-assisted CBT (CCBT), Treatment as Usual (TAU)
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-assisted CBT (CCBT)Behavioural
Computer-assisted psychotherapy for depression using a computer program plus clinician support
Ordinary treatment for depression in primary care setting
| Study group | Role | What they receive |
|---|---|---|
| Computer-assisted CBT (CCBT) | Experimental | 12 weeks of CCBT for depression Receives: Behavioral: Computer-assisted CBT (CCBT) |
| Treatment as Usual (TAU) | Active comparator | Treatment as usual by primary care physicians Receives: Other: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire - 9
Self-report scale for depression
Measured: 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
Self-report measure of negative cognitions
Measured: 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
Self-report measure of quality of life
Measured: Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment period ends
Client Service Receipt Inventory
Record of medical and related services
Measured: Change from baseline after 12 weeks of treatment and 3 and 6 months after 12-week treatment ends
Quality of Well Being Scale
Self-report measure of well-being
Measured: 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
Assessment of patient attitudes toward treatment
Measured: Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment periods ends
Generalized Anxiety Disorder - 7
Self-report measure of anxiety
Measured: Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment period ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- University of Denver, University of York
- Responsible party
- Principal investigator, Jesse H Wright, University of Louisville
- Investigators
- Jesse Wright, M.D., Ph.D., Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700009
- Sponsor's protocol ID
- 15.0640
- Other IDs
- R18HS024047
- Status last verified
- Mar 2025
- First submitted
- 25 Feb 2016
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 35142833
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissemination of Computer-assisted Cognitive-behavior Therapy for Depression in Primary Care
- ClinicalTrials.gov ID
- NCT02700009
- Acronym / sponsor ID
- 15.0640
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- University of Denver, University of York
- Study start
- May 2016
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 7 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Computer-assisted cognitive-behavior therapy (CCBT) for depression in primary care will be evaluated in a trial with 320 patients randomly assigned to CCBT or treatment as usual (TAU). The study will disseminate a therapy method found to be effective in psychiatric settings into primary care - a setting where there have been significant problems in delivery of adequate, evidence-based treatment for depression. The study will include a high percentage of disadvantaged patients - a population that has been largely ignored in previous research in CCBT. There have been no previous studies of CCBT for depression in primary care that have enrolled large numbers of disadvantaged patients. The form of CCBT used in this study is designed to increase access to effective therapy, provide a cost-effective method, and be a sustainable model for wide-spread use in primary care.
In order to deliver therapy in a practical manner that can be replicated in other primary care practices, patients with significant symptoms of depression will receive treatment with an empirically supported computer program that builds cognitive-behavior therapy skills. Support for CCBT will be provided by telephone and/or e-mail contact with a care coordinator instead of the face-to-face treatment with a cognitive-behavior therapist that has been a part of CCBT delivery in mental health settings. Novel features of this treatment program include: 1) fully detailed and replicable method for integrating clinician support with CCBT in primary care; 2) delivery of CCBT to a population with high percentage of disadvantaged patients; 3) integration of CCBT into the primary care delivery model; 4) highly interactive, multimedia computer program with adaptations for persons who may have lower levels of education or computer experience; 5) advanced cost-benefit analysis including data on actual health care utilization and costs; 6) exploration of moderators and predictors of treatment outcome.
Outcome will be assessed by measuring CCBT completion rate, comprehension of CBT concepts, and satisfaction with treatment; in addition to ratings of depressive symptoms, negative thoughts, and quality of life. The cost-effectiveness analysis and exploration of possible predictors of outcome should help clinicians, health care organizations, and others plan further dissemination of CCBT in primary care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer-assisted CBT (CCBT) | Experimental | Behavioral: Computer-assisted CBT (CCBT)12 weeks of CCBT for depression |
| Treatment as Usual (TAU) | Active comparator | Other: Treatment as Usual (TAU)Treatment as usual by primary care physicians |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient Health Questionnaire score of 10 or above
- Age 18 or above
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer-assisted CBT (CCBT)Computer-assisted psychotherapy for depression using a computer program plus clinician support | Behavioural | Computer-assisted CBT (CCBT) |
| Treatment as Usual (TAU)Ordinary treatment for depression in primary care setting | Other | Treatment as Usual (TAU) |
Primary outcome
Patient Health Questionnaire - 9
Time frame: Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment period ends
Self-report scale for depression
6 secondary outcomes
Automatic Thoughts Questionnaire
Time frame: 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
Time frame: Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment period ends
Client Service Receipt Inventory
Time frame: Change from baseline after 12 weeks of treatment and 3 and 6 months after 12-week treatment ends
Quality of Well Being Scale
Time frame: 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
Time frame: Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment periods ends
Generalized Anxiety Disorder - 7
Time frame: Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment period ends
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Derived from this study: PubMed 35142833Wright 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesse Wright, M.D., Ph.D. principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-assisted CBT (CCBT) and Treatment as Usual (TAU) in people with Depression, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire - 9 (time frame: Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment period ends). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02700009, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025; AzTrials last refreshed its copy on 2 Nov 2026.