AnxietyNCT03820973
Brief Cognitive Behavioral Therapy for Anxiety
A study testing Brief CBT for Anxiety in people with Anxiety, run by Michael E. DeBakey VA Medical Center at 1 site in United States.
Trial summary
The proposed clinical intervention is a modular skills-based intervention for flexible delivery of care, measurement-based care practices, and integration of exposure strategies critical for anxiety symptom reduction. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Brief CBT for Anxiety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 1 Sep 2021
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran participants: The sample will include Veterans who:
- receive care at the Houston VA and surrounding area CBOCs,
- have documentation in the medical chart of an anxiety disorder or anxiety-related problems, and
- report clinically significant symptoms of anxiety, defined as a score of 10 or greater on the Generalized Anxiety Disorder Scale, 7th edition (GAD-7).
Who cannot join
- Veteran participants will be excluded for factors that would render bCBT inappropriate, including:
- cognitive impairment;
- presence of bipolar, psychotic or substance use disorders, and
- Veteran is currently receiving psychotherapy for anxiety. If receiving medications that target anxiety Veterans WILL NOT be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Pilot Testing of Video-based Deliver of Brief Cognitive Behavioral Therapy for Anxiety
The proposed clinical intervention is a modular skills-based intervention for flexible delivery of care, measurement-based care practices, and integration of exposure strategies critical for anxiety symptom reduction. Notably, the treatment targets anxiety symptoms rather than diagnoses to improve use in PCMHI and CBOC settings. The pilot study will develop and conduct preliminary testing of bCBT for anxiety using Veterans Affairs (VA) Video Connect to Home (VVC-H) to deliver care.
Read the detailed description
Anxiety disorders are identified in over 30% of primary care patients and are associated with substantial functional impairment, poor health-related quality of life, and suicide; however, rates of treatment are low. In contrast to advances in improving treatment of depression and posttraumatic stress disorder in VA, far less attention has been given to anxiety disorders. In the absence of VA clinical practice guidelines for anxiety disorders, evidence-based treatment practices are unstandardized in VA primary care and Community Based Outpatient Clinics (CBOCs). Cognitive behavioral therapy (CBT) is an evidence-based intervention for the anxiety disorders but was developed for use in specialty mental health settings and often targets individual anxiety disorders (e.g.generalized anxiety, panic, and social phobia) with diagnosis-specific treatment packages. These interventions are not practical for primary care and CBOC settings where treatment must be brief and focused on reduction of anxiety symptoms rather than targeted anxiety diagnoses. Further complicating the delivery of CBT for anxiety disorders is that repeated exposure to feared cues is considered a critical component of CBT for anxiety but is rarely used in these settings. Providers within VA currently have no standardized options for delivering brief evidence-based psychotherapy for Veterans with anxiety. Although Primary Care Mental Health Integration (PCMHI) and CBOCs increase access to mental health services, VA recognizes the need to deliver mental health services using video to home technology to increase access, decrease barriers (i.e., geographic distance, transportation, travel time, stigma, child care) and provide more Veteran-centric care. VA is pioneering implementation of VA Video Connect to Home (VVC-H) technology in specialty mental health clinics, but VVC-H continues to be rarely used and little is known about the implementation potential of VVC-H to improve psychotherapy access and outcomes in primary care and CBOC settings. In summary, VA needs a flexible evidence-based approach for anxiety that fits within primary care and CBOC settings and offers innovative delivery strategies to increase access to care. Although treatment in PCMHI and CBOC settings must be time-limited, it must also be highly effective. The investigators have developed robust brief CBT (bCBT) interventions and provider support programs for depression and is now seeking to address anxiety using a similar approach. The proposed clinical intervention will use state-of-the-art practices including delivery of services via VVC-H. This open trial seeks to recruit 12 Veterans who have significant anxiety symptoms according to the GAD-7 (standard assessment tool for VA clinical settings). Veterans will be recruited from the Michael E. DeBakey VAMC primary care clinic and affiliated Community Based Outpatient Clinics (CBOCs).
- Conditions
- Anxiety
- Being tested
- Brief CBT for Anxiety
- Keywords
- brief Cognitive Behavioral Therapy, VA Video Connect to home
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief CBT for AnxietyBehavioural
All participants will receive psychoeducation on anxiety and bCBT treatment approach, work on setting goals, begin self-monitoring, and select skill sessions that fit his/her most pressing needs. Available skills: Relaxation-Diaphragmatic breathing is a simple relaxation technique that increases oxygen flow and reduces the unpleasant physiological sensations associated with anxiety; Exposure - designed to educate Veterans about the role of avoidance in maintaining anxiety problems, as well as information about how to reduce avoidance through exposure exercises; Cognitive - Veterans may opt to address anxiety and worry through modifying negative thinking patterns. Two available options - Increasing Helpful Thoughts and Managing Unhelpful Thoughts.
| Study group | Role | What they receive |
|---|---|---|
| Brief CBT for Anxiety | Experimental | Participants will receive Brief Cognitive Behavioral Therapy for Anxiety (bCBT). Sessions with clinicians will be provided via VA Video Connect to Home (VVC-H). Participants will have the option to select from a list of skills to tailor to his/her preferences. Participants will be able to receive up to 9 total sessions and generally last 30 to 40 minutes. For the purpose of this study, treatment duration will be limited to 3 months to ensure standardization of study outcome measures. Receives: Behavioral: Brief CBT for Anxiety |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generalized Anxiety Disorder - 7 item scale - looking at change in scores over time
scale used to measure anxiety, scores range from 0 to 21, where higher scores equal higher levels of anxiety.
Measured: Baseline, and 3-Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start1 Feb 2019
- Primary completion1 Jul 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael E. DeBakey VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Jeffrey Cully, Michael E. DeBakey VA Medical Center
- Investigators
- Jeffrey Cully, PhD, Principal investigator, Michael E. DeBakey VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03820973
- Sponsor's protocol ID
- H-44258
- Status last verified
- Apr 2022
- First submitted
- 25 Jan 2019
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Pilot Testing of Video-based Deliver of Brief Cognitive Behavioral Therapy for Anxiety
- ClinicalTrials.gov ID
- NCT03820973
- Acronym / sponsor ID
- H-44258
- Conditions
- Anxiety
- Keywords
- brief Cognitive Behavioral Therapy, VA Video Connect to home
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Michael E. DeBakey VA Medical CenterUS federal agency
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 29 Jan 2019 (actual)
- 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.
The proposed clinical intervention is a modular skills-based intervention for flexible delivery of care, measurement-based care practices, and integration of exposure strategies critical for anxiety symptom reduction. Notably, the treatment targets anxiety symptoms rather than diagnoses to improve use in PCMHI and CBOC settings. The pilot study will develop and conduct preliminary testing of bCBT for anxiety using Veterans Affairs (VA) Video Connect to Home (VVC-H) to deliver care.
Detailed description
Anxiety disorders are identified in over 30% of primary care patients and are associated with substantial functional impairment, poor health-related quality of life, and suicide; however, rates of treatment are low. In contrast to advances in improving treatment of depression and posttraumatic stress disorder in VA, far less attention has been given to anxiety disorders. In the absence of VA clinical practice guidelines for anxiety disorders, evidence-based treatment practices are unstandardized in VA primary care and Community Based Outpatient Clinics (CBOCs). Cognitive behavioral therapy (CBT) is an evidence-based intervention for the anxiety disorders but was developed for use in specialty mental health settings and often targets individual anxiety disorders (e.g.generalized anxiety, panic, and social phobia) with diagnosis-specific treatment packages. These interventions are not practical for primary care and CBOC settings where treatment must be brief and focused on reduction of anxiety symptoms rather than targeted anxiety diagnoses. Further complicating the delivery of CBT for anxiety disorders is that repeated exposure to feared cues is considered a critical component of CBT for anxiety but is rarely used in these settings. Providers within VA currently have no standardized options for delivering brief evidence-based psychotherapy for Veterans with anxiety. Although Primary Care Mental Health Integration (PCMHI) and CBOCs increase access to mental health services, VA recognizes the need to deliver mental health services using video to home technology to increase access, decrease barriers (i.e., geographic distance, transportation, travel time, stigma, child care) and provide more Veteran-centric care. VA is pioneering implementation of VA Video Connect to Home (VVC-H) technology in specialty mental health clinics, but VVC-H continues to be rarely used and little is known about the implementation potential of VVC-H to improve psychotherapy access and outcomes in primary care and CBOC settings. In summary, VA needs a flexible evidence-based approach for anxiety that fits within primary care and CBOC settings and offers innovative delivery strategies to increase access to care. Although treatment in PCMHI and CBOC settings must be time-limited, it must also be highly effective. The investigators have developed robust brief CBT (bCBT) interventions and provider support programs for depression and is now seeking to address anxiety using a similar approach. The proposed clinical intervention will use state-of-the-art practices including delivery of services via VVC-H. This open trial seeks to recruit 12 Veterans who have significant anxiety symptoms according to the GAD-7 (standard assessment tool for VA clinical settings). Veterans will be recruited from the Michael E. DeBakey VAMC primary care clinic and affiliated Community Based Outpatient Clinics (CBOCs).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brief CBT for Anxiety | Experimental | Behavioral: Brief CBT for AnxietyParticipants will receive Brief Cognitive Behavioral Therapy for Anxiety (bCBT). Sessions with clinicians will be provided via VA Video Connect to Home (VVC-H). Participants will have the option to select from a list of skills to tailor to his/her preferences. Participants will be able to receive up to 9 total sessions and generally last 30 to 40 minutes. For the purpose of this study, treatment duration will be limited to 3 months to ensure standardization of study outcome measures. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- receive care at the Houston VA and surrounding area CBOCs,
- have documentation in the medical chart of an anxiety disorder or anxiety-related problems, and
- report clinically significant symptoms of anxiety, defined as a score of 10 or greater on the Generalized Anxiety Disorder Scale, 7th edition (GAD-7).
Key exclusion criteria (4 listed)
- Veteran participants will be excluded for factors that would render bCBT inappropriate, including:
- cognitive impairment;
- presence of bipolar, psychotic or substance use disorders, and
- Veteran is currently receiving psychotherapy for anxiety. If receiving medications that target anxiety Veterans WILL NOT 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 |
|---|---|---|
| Brief CBT for AnxietyAll participants will receive psychoeducation on anxiety and bCBT treatment approach, work on setting goals, begin self-monitoring, and select skill sessions that fit his/her most pressing needs. Available skills: Relaxation-Diaphragmatic breathing is a simple relaxation technique that increases oxygen flow and reduces the unpleasant physiological sensations associated with anxiety; Exposure - designed to educate Veterans about the role of avoidance in maintaining anxiety problems, as well as information about how to reduce avoidance through exposure exercises; Cognitive - Veterans may opt to address anxiety and worry through modifying negative thinking patterns. Two available options - Increasing Helpful Thoughts and Managing Unhelpful Thoughts. | Behavioural | Brief CBT for Anxiety |
Primary outcome
Generalized Anxiety Disorder - 7 item scale - looking at change in scores over time
Time frame: Baseline, and 3-Months
scale used to measure anxiety, scores range from 0 to 21, where higher scores equal higher levels of anxiety.
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 22 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Anxiety
Recruiting
Internet-Based EMDR Flash Intervention for Test Anxiety in University Students
Test Anxiety
Recruiting
Inspiratory Muscle Training and Diaphragmatic Breathing in GAD
Generalized Anxiety Disorder (GAD)
Recruiting
Comparative Evaluation of Intranasal Atomized Midazalom Combined With Nitrous Oxide Versus Nitrous Oxide Monotherapy
Dental Anxiety in Children, Child Behaviour
Recruiting
High-Intensity, Low-Frequency Periodic rTMS Over the Right Dorsolateral Prefrontal Cortex on Cardiac Autonomic Regulation in Women With Recurrent Pregnancy Loss and Anxiety
Recurrent Pregnancy Loss(RPL), Anxiety
Enrolling by invitation
Family Accommodation Reduction in Adult Obsessive Compulsive Disorder: A Randomized Controlled Trial
Obsessive - Compulsive Disorder, Family Accommodation
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 principal investigator
Michael E. DeBakey VAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief CBT for Anxiety in people with Anxiety, run by Michael E. DeBakey VA Medical Center 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 4 inclusion and 4 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 22 Apr 2022. 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?
Generalized Anxiety Disorder - 7 item scale - looking at change in scores over time (time frame: Baseline, and 3-Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2022.