Anxiety
Conditions
Keywords
anxiety disorder, panic disorder, phobia, social, worry, stress
Brief summary
This 4-year study will examine the value of a type of a brief cognitive behavioral therapy treatment for Veterans with anxiety and worry. This treatment will be delivered either in-person, or by video telehealth to the Veteran's home. The treatment will be delivered by providers at three Veterans Administration Medical Centers (Houston, New Orleans, and San Antonio). The study will compare the helpfulness of this treatment to the usual care Veterans receive for anxiety and worry. A supplement to this study will also evaluate daily discrimination experiences of Veterans based on the participant's race, ethnicity, religion, physical appearance, or other characteristics.
Detailed description
This multisite trial (Houston, New Orleans and San Antonio) will use a pragmatic randomized trial design to examine the effectiveness and implementation potential of a brief cognitive behavioral therapy(bCBT) intervention for anxiety delivered either in-person or via VA Video Connect-Home (VVC-H), according to patient preference. Brief CBT will be delivered by existing Primary Care Mental Health Integration (PCMHI) providers at three large VAMCs (Houston, New Orleans, and San Antonio). Aim 1 will examine the clinical effectiveness of the bCBT intervention vs. Enhanced Usual Care (EUC) for anxiety at 4-, 8-, and 12-month follow-ups. Aim 2 will determine factors associated with bCBT response and explore Veteran demographic and clinical factors associated with VVC-H engagement. An exploratory aim will use mixed, qualitative and quantitative methods to better understand implementation successes and challenges related to delivery and impact of bCBT anxiety and VVC-H use in the PCMHI setting. The primary hypothesis is that anxiety outcomes, as measured by the General Anxiety Disorder 7-item scale (GAD-7) will be superior at 4-, 8-, and 12-month follow up for patients who are assigned to receive bCBT vs. EUC. In addition, participants will be asked to complete the Diversity Supplement measures and qualitative interview to evaluate whether sociocultural factors are associated with the severity and type of anxiety symptoms among Veterans of different race/ethnicity groups.
Interventions
BEHAVIORALBrief Cognitive Behavioral Therapy
The proposed bCBT treatment for anxiety was specifically designed for use within VA PCMHI settings and uses a patient-centered approach to increase engagement while addressing the mental health needs of anxious Veterans. Emphasis was placed on maximizing intervention potency and minimizing intensity and duration to improve implementation value and alignment with VA PCMHI requirements. The intervention directly addresses challenges to delivery of CBT providing 1) a brief, practical model of care to address multiple anxiety conditions consistent with the PCMHI model (e.g. 4-6 sessions; measurement-based care), and 2) a clinically potent intervention that includes exposure-based skills.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome data will be collected by independent evaluators (IEs) who will be blinded to randomization. All IEs will be based in Houston, with direct oversight by Dr. Cully. IEs will undergo training and calibration on all study measures and be regularly reassessed for quality.
Intervention model description
Cognitive behavioral therapy (CBT) is an evidence-based practice (EBP) for all types of anxiety disorders including generalized anxiety disorder (GAD), panic disorder, and social anxiety disorder. The proposed bCBT treatment for anxiety was specifically designed for use within VA PCMHI settings and uses a patient-centered approach to increase engagement while addressing the mental health needs of anxious Veterans. Emphasis was placed on maximizing intervention potency and minimizing intensity and duration to improve implementation value and alignment with VA PCMHI requirements. The intervention directly addresses challenges to delivery of CBT providing 1) a brief, practical model of care to address multiple anxiety conditions consistent with the PCMHI model (e.g. 4-6 sessions; measurement-based care), and 2) a clinically potent intervention that includes exposure-based skills.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must be a United States military Veteran * Veteran participants will be current recipients of services at the Houston, New Orleans, or San Antonio VA Medical Centers. * Patients who have received Primary Care Mental Health Integration services, or are eligible for PCMHI services (They are not receiving specialty mental health services) * Veterans with clinically significant symptoms of anxiety will be included after screening on two occasions to ensure consistency of anxiety symptoms (GAD-7 score of 10 or greater; telephone screen and baseline appointment).
Exclusion criteria
* Cognitive impairment * Presence of bipolar, psychotic or substance-abuse disorders. * Veterans currently receiving psychotherapy for anxiety at the time of enrollment will be excluded so as not to duplicate services (Current treatment will be defined as patients that have received a psychotherapy appointment within the last 3 months).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| General Anxiety Disorder-7 (GAD-7) | Baseline, 4-, 8-, and 12-month | The GAD-7 is a seven-item self-report instrument for screening, diagnosis, and severity assessment of anxiety disorders. It is psychometrically strong and valid for use in the primary care setting. A GAD-7 score of 10 or higher will be required for study inclusion. The GAD-7 total score for the seven items ranges from 0 to 21: 0-4 Minimal anxiety; 5-9 Mild anxiety; 10-14 Moderate anxiety; 15-21 Severe anxiety. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Anxiety Severity and Impairment Scale (OASIS) | Baseline, 4-, 8-, and 12-month | The OASIS will be a secondary measure of anxiety. Unlike the GAD-7, which will be administered by both research staff and PCMHI providers, the OASIS will only be administered by research staff, thereby avoiding response bias that may occur in the clinical setting. The OASIS is a widely used five-item measure of anxiety for primary care settings assessing anxiety frequency, anxiety severity, avoidance behaviors, social interference, and interference at work, school, or home. Each item of the OASIS instructs respondents to endorse one of five responses that best describes their experiences over the past week. Response items are coded from 0 to 4 and can be summed to obtain a total score ranging from 0 to 20. A higher score indicates a poorer outcome. |
| Short Form-12 Physical Component Summary (SF-12-PCS) | Baseline, 4-, 8-, and 12-month | The SF-12-PCS is a condensed, self-reported outcome measure assessing the impart of health on an individual's everyday life. Physical Composite Scores are computed using the score of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The investigators will assess quality of life using the 12-item Short Form Health Survey for Veterans (SF12V), an instrument adopted by VHA as a measure of functional status. SF-12V responses can be summarized in component scores for physical (PCS) and mental (MCS) functioning. |
| Short Form-12 Mental Component Summary (SF12-MCS) | Baseline, 4-, 8-, 12-month | The SF12-MCS is a 12-question, patient reported survey evaluating emotional well-being. Mental Health Composite Scores are computed using the score of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The investigators assessed quality of life using the 12-item Short Form Health Survey for Veterans (SF12V), an instrument adopted by VHA as a measure of functional status. SF-12V responses can be summarized in component scores for physical (PCS) and mental (MCS) functioning. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTerri L. Fletcher, PhD
Michael E. DeBakey VA Medical Center, Houston, TX
Participant flow
Recruitment details
Veterans enrolled in Houston, New Orleans, and San Antonio VA Medical Centers were recruited if they: 1) were diagnosed with anxiety disorders and 2) had significant anxiety symptoms (GAD-7 score≥10). Exclusion criteria: 1) cognitive impairment, 2) bipolar or psychotic disorders, 3) substance use disorders, and 4) current psychotherapy for anxiety. Recruitment involved opt-out letters, phone calls, and direct provider referral. Interested Veterans underwent 2 screenings for anxiety.
Pre-assignment details
Eligibility determination occurred after informed consent. Of the 347 Veterans who signed consent forms, many were deemed ineligible at baseline due to various reasons: 1) being unreachable or declining assessment, 2) not meeting the required GAD-7 scores, 3) having an excluded mental health diagnosis, 4) receiving mental health treatment, or 5) relocating outside the catchment area. Ultimately, 225 eligible participants were randomized to treatment (60%) or Enhanced Usual Care (EUC) (40%).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Age at baseline | 53.2 Years STANDARD_DEVIATION 13.7 |
| Current Relationship Status Married / In Civil Union / Living Together | 62 Participants |
| Current Relationship Status Not Married / Not in Civil Union / Living Apart | 16 Participants |
| Current Relationship Status Single / Not in a Relationship | 23 Participants |
| Education Associate Degree | 13 Participants |
| Education Bachelor's Degree | 50 Participants |
| Education Graduate Degree | 16 Participants |
| Education <High School / HS / Vocational School | 29 Participants |
| Education Some College | 29 Participants |
| Race/Ethnicity, Customized African American | 61 Participants |
| Race/Ethnicity, Customized Hispanic / Latino | 10 Participants |
| Race/Ethnicity, Customized Other | 9 Participants |
| Race/Ethnicity, Customized White | 80 Participants |
| Sex/Gender, Customized Female | 56 Participants |
| Sex/Gender, Customized Male | 78 Participants |
| Sex/Gender, Customized Prefer Not To Answer | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 134 | 0 / 91 |
| other Total, other adverse events | 0 / 134 | 0 / 91 |
| serious Total, serious adverse events | 0 / 134 | 0 / 91 |
Outcome results
None listed