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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

United States1 site
  • Michael E. DeBakey VAMC

    Houston, Texas, 77030

Other trials in United States

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 groups in NCT03820973
Study groupRoleWhat they receive
Brief CBT for AnxietyExperimentalParticipants 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.

  1. 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.

  1. First posted29 Jan 2019
  2. Study start1 Feb 2019
  3. Primary completion1 Jul 2021
  4. Study completion1 Sep 2021

Resources

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)
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

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.

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