DepressionMyBriefCBTNCT02466126
Effectiveness and Implementation of Brief Cognitive Behavioral Therapy in CBOCs
A study testing bCBT in people with Depression, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
The purpose of this study is to determine the effectiveness of a brief cognitive behavioral therapy (bCBT) intervention for Veterans with depression delivered by mental health providers located at VA Community Based Outpatient Clinics (CBOC's) associated with the Houston and Oklahoma City VAMCs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- bCBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2015to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- must have clinically significant symptoms of depression;
- must be current recipients of services at CBOCs associated with the Houston and Oklahoma City VAMCs.
Who cannot join
- cognitive impairment;
- presence of bipolar, psychotic or substance-abuse disorders.
- Veterans currently receiving psychotherapy WILL be excluded.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030-4211
Oklahoma City VA Medical Center, Oklahoma City, OK
Oklahoma City, Oklahoma, 73104-5007
About this study
The purpose of this study is to determine the effectiveness of a brief cognitive behavioral therapy (bCBT) intervention for Veterans with depression delivered by mental health providers located at VA Community Based Outpatient Clinics (CBOC's) associated with the Houston and Oklahoma City VAMCs.
Read the detailed description
Depression is a serious health condition that places tremendous burden on patients and healthcare systems and is especially prevalent in Veterans. In 2008, the VHA released the Uniform Mental Health Services Handbook (Handbook 1160.01) in an effort to expand services for Veterans with depression, including those in primary care and CBOC settings.
The VA remains a national leader in mental health services, but the provision of psychotherapy within VA is limited, especially for rural Veterans and those cared for in CBOCs. The VA has invested significant resources to improve access to high-quality mental health care, including a rapid expansion into CBOCs. Currently, there is a need to work with clinicians and stakeholders to address practice barriers related to mental health practices in CBOCs. A recent survey of 4,200 mental health providers in VA found that, although robust expansion and improved quality of mental health care services has occurred, access to proven effective psychotherapies in CBOCs remains a focused area for improvement. The study will examine whether existing VA CBOC mental health clinicians, with training and support, can effectively administer a structured brief cognitive behavioral therapy (bCBT) intervention for Veterans with clinically elevated symptoms of depression.
- Conditions
- Depression
- Being tested
- bCBT
- Keywords
- Depression, brief Cognitive Behavioral Therapy (bCBT), Randomized Controlled Trial
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bCBTBehavioural
The bCBT intervention uses 6 active-treatment sessions, each lasting 30 to 40 minutes, and telephone booster sessions to solidify changes. All participants receive an initial (core) session. In this session, participants work with their study clinician to set goals that are not restricted to "emotional health" (e.g., depression) but may also address "physical health" concerns (e.g., diet, exercise, managing a chronic condition). Following the core session, clinicians provide participants with a series of module choices, from which they select skills that match their most pressing needs. Each module focuses on a CBT technique (e.g., behavioral activation, changing thoughts), introduced and customized to the patient's immediate goals, regardless of the focus (physical or mental health).
| Study group | Role | What they receive |
|---|---|---|
| bCBT/Direct Referral | Experimental | A brief cognitive behavioral therapy intervention that offers 6 active- treatment sessions, each lasting 30 to 40 minutes, and telephone booster sessions to maintain changes. Receives: Behavioral: bCBT |
| Enhanced Usual Care (EUC) | No intervention | Participants are provided with educational information on depression and will be encouraged to seek additional depression care options through their primary care providers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire (PHQ-9); Change in Depression Scores Taken at 4-, 8-, and 12-month Follow Ups as Compared to Baseline.
The PHQ-9 is used to measure a person's level of depression. Scores on the measure can range from 0 to 27. The higher the score the higher level of depression someone is experiencing.
Measured: Baseline, 4-month (immediate post treatment), and 8- and 12-month follow up.
Secondary outcomes (2)
Beck Depression Inventory (BDI) - Change is Being Assessed Using a 4 Timepoint Process
The measure will be used a s a second assessment to measure depression. Scores on the measure can range from 0 to 63. The higher the score the higher level of depression someone is experiencing.
Measured: Baseline, 4-month (immediate post treatment), and 8- and 12-month follow up.
Health Survey for Veterans (SF-12) - Change is Being Assessed Using a 4 Timepoint Process
SF-12 will be used to measure a participant's functional status. The SF-12V measures 8 concepts of health and can be summarized into summary component scores for physical (PCS) and mental (MCS) functioning. Scores can range from 0 - 100 and higher scores mean better functioning and quality of life.
Measured: Baseline, 4-month (immediate post treatment), and 8- and 12-month follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study start1 Dec 2015
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jeffrey Cully, PhD MEd, Principal investigator, Michael E. DeBakey VA Medical Center, Houston, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02466126
- Sponsor's protocol ID
- IIR 13-315
- Acronym
- MyBriefCBT
- Status last verified
- Jul 2023
- First submitted
- 1 Jun 2015
- Last updated
- 27 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Johnson AL, Ecker AH, Fletcher TL, Hundt N, Kauth MR, Martin LA, Curran GM, Cully JA. Increasing the impact of randomized controlled trials: an example of a hybrid effectiveness-implementation design in psychotherapy research. Transl Behav Med. 2020 Aug 7;10(3):629-636. doi: 10.1093/tbm/iby116.
PubMed 30476315Brandt CP, Deavers F, Hundt NE, Fletcher TL, Cully JA. The Impact of Integrating Physical Health into a Brief CBT Approach for Medically Ill Veterans. J Clin Psychol Med Settings. 2020 Jun;27(2):285-294. doi: 10.1007/s10880-019-09634-2.
PubMed 31201653Ecker AH, Shivaji S, Plasencia M, Kauth MR, Hundt NE, Fletcher TL, Sansgiry S, Cully JA. The role of symptom reduction in improving health-related quality of life through brief cognitive behavioral therapy. Psychother Res. 2025 Jul;35(6):972-980. doi: 10.1080/10503307.2024.2349992. Epub 2024 Jun 11.
PubMed 38861659Cully JA, Hundt NE, Fletcher T, Sansgiry S, Zeno D, Kauth MR, Kunik ME, Sorocco K. Brief Cognitive-Behavioral Therapy for Depression in Community Clinics: A Hybrid Effectiveness-Implementation Trial. Psychiatr Serv. 2024 Mar 1;75(3):237-245. doi: 10.1176/appi.ps.20220582. Epub 2023 Sep 7.
PubMed 37674395Rassu FS, Sansgiry S, Hundt NE, Kunik ME, Cully JA. Presence of PTSD is Associated with Clinical and Functional Impact in Veterans with Depression Treated in Community-Based Clinics. J Clin Psychol Med Settings. 2022 Mar;29(1):220-229. doi: 10.1007/s10880-021-09796-y. Epub 2021 Jun 22.
PubMed 34156589
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Implementation of Brief Cognitive Behavioral Therapy in CBOCs
- ClinicalTrials.gov ID
- NCT02466126
- Acronym / sponsor ID
- MyBriefCBT / IIR 13-315
- Conditions
- Depression
- Keywords
- Depression, brief Cognitive Behavioral Therapy (bCBT), Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 9 Jun 2015 (estimated)
- Results
- Posted 25 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effectiveness of a brief cognitive behavioral therapy (bCBT) intervention for Veterans with depression delivered by mental health providers located at VA Community Based Outpatient Clinics (CBOC's) associated with the Houston and Oklahoma City VAMCs.
Detailed description
Depression is a serious health condition that places tremendous burden on patients and healthcare systems and is especially prevalent in Veterans. In 2008, the VHA released the Uniform Mental Health Services Handbook (Handbook 1160.01) in an effort to expand services for Veterans with depression, including those in primary care and CBOC settings.
The VA remains a national leader in mental health services, but the provision of psychotherapy within VA is limited, especially for rural Veterans and those cared for in CBOCs. The VA has invested significant resources to improve access to high-quality mental health care, including a rapid expansion into CBOCs. Currently, there is a need to work with clinicians and stakeholders to address practice barriers related to mental health practices in CBOCs. A recent survey of 4,200 mental health providers in VA found that, although robust expansion and improved quality of mental health care services has occurred, access to proven effective psychotherapies in CBOCs remains a focused area for improvement. The study will examine whether existing VA CBOC mental health clinicians, with training and support, can effectively administer a structured brief cognitive behavioral therapy (bCBT) intervention for Veterans with clinically elevated symptoms of depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bCBT/Direct Referral | Experimental | Behavioral: bCBTA brief cognitive behavioral therapy intervention that offers 6 active- treatment sessions, each lasting 30 to 40 minutes, and telephone booster sessions to maintain changes. |
| Enhanced Usual Care (EUC) | No intervention | –Participants are provided with educational information on depression and will be encouraged to seek additional depression care options through their primary care providers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- must have clinically significant symptoms of depression;
- must be current recipients of services at CBOCs associated with the Houston and Oklahoma City VAMCs.
Key exclusion criteria (3 listed)
- cognitive impairment;
- presence of bipolar, psychotic or substance-abuse disorders.
- Veterans currently receiving psychotherapy WILL be excluded.
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 |
|---|---|---|
| bCBTThe bCBT intervention uses 6 active-treatment sessions, each lasting 30 to 40 minutes, and telephone booster sessions to solidify changes. All participants receive an initial (core) session. In this session, participants work with their study clinician to set goals that are not restricted to "emotional health" (e.g., depression) but may also address "physical health" concerns (e.g., diet, exercise, managing a chronic condition). Following the core session, clinicians provide participants with a series of module choices, from which they select skills that match their most pressing needs. Each module focuses on a CBT technique (e.g., behavioral activation, changing thoughts), introduced and customized to the patient's immediate goals, regardless of the focus (physical or mental health). | Behavioural | bCBT/Direct Referral |
Primary outcome
Patient Health Questionnaire (PHQ-9); Change in Depression Scores Taken at 4-, 8-, and 12-month Follow Ups as Compared to Baseline.
Time frame: Baseline, 4-month (immediate post treatment), and 8- and 12-month follow up.
The PHQ-9 is used to measure a person's level of depression. Scores on the measure can range from 0 to 27. The higher the score the higher level of depression someone is experiencing.
2 secondary outcomes
Beck Depression Inventory (BDI) - Change is Being Assessed Using a 4 Timepoint Process
Time frame: Baseline, 4-month (immediate post treatment), and 8- and 12-month follow up.
Health Survey for Veterans (SF-12) - Change is Being Assessed Using a 4 Timepoint Process
Time frame: Baseline, 4-month (immediate post treatment), and 8- and 12-month follow up.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30476315Johnson AL, Ecker AH, Fletcher TL, Hundt N, Kauth MR, Martin LA, Curran GM, Cully JA. Increasing the impact of randomized controlled trials: an example of a hybrid effectiveness-implementation design in psychotherapy research. Transl Behav Med. 2020 Aug 7;10(3):629-636. doi: 10.1093/tbm/iby116.
- Results publication: PubMed 31201653Brandt CP, Deavers F, Hundt NE, Fletcher TL, Cully JA. The Impact of Integrating Physical Health into a Brief CBT Approach for Medically Ill Veterans. J Clin Psychol Med Settings. 2020 Jun;27(2):285-294. doi: 10.1007/s10880-019-09634-2.
- Derived from this study: PubMed 38861659Ecker AH, Shivaji S, Plasencia M, Kauth MR, Hundt NE, Fletcher TL, Sansgiry S, Cully JA. The role of symptom reduction in improving health-related quality of life through brief cognitive behavioral therapy. Psychother Res. 2025 Jul;35(6):972-980. doi: 10.1080/10503307.2024.2349992. Epub 2024 Jun 11.
- Derived from this study: PubMed 37674395Cully JA, Hundt NE, Fletcher T, Sansgiry S, Zeno D, Kauth MR, Kunik ME, Sorocco K. Brief Cognitive-Behavioral Therapy for Depression in Community Clinics: A Hybrid Effectiveness-Implementation Trial. Psychiatr Serv. 2024 Mar 1;75(3):237-245. doi: 10.1176/appi.ps.20220582. Epub 2023 Sep 7.
- Derived from this study: PubMed 34156589Rassu FS, Sansgiry S, Hundt NE, Kunik ME, Cully JA. Presence of PTSD is Associated with Clinical and Functional Impact in Veterans with Depression Treated in Community-Based Clinics. J Clin Psychol Med Settings. 2022 Mar;29(1):220-229. doi: 10.1007/s10880-021-09796-y. Epub 2021 Jun 22.
- 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.
Jeffrey Cully, PhD MEd principal investigator
Michael E. DeBakey VA Medical Center, Houston, TX
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bCBT in people with Depression, run by VA Office of Research and Development at 2 sites 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 3 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 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 25 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (PHQ-9); Change in Depression Scores Taken at 4-, 8-, and 12-month Follow Ups as Compared to Baseline. (time frame: Baseline, 4-month (immediate post treatment), and 8- and 12-month follow up.). 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 NCT02466126, which also lists 5 linked publications.
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 27 Jul 2023.