Anxiety Sensitivity, Functional Impairment
Conditions
Keywords
Anxiety
Brief summary
This pilot study trial will test the acceptability, feasibility, and usability of a brief enhanced anxiety sensitivity treatment to reduce anxiety sensitivity and functional impairment in Veterans.
Detailed description
This study tests a treatment with two components: first, there is a single session face-to-face virtual intervention delivered by the counselor or therapist via VA Video Connect software. Second, a mobile app (mPRO) is used for EMA and to deliver EMI components. Veterans will be enrolled following informed consent. The research staff will read the measures to the Veteran who will verbally provide their answers. Veterans will next complete the baseline assessment. At the baseline assessment, Veterans meet with the Project Coordinator by phone or virtually to complete a consenting process, guidance on the video software being used, and set-up and guidance on use of the mobile app. Following the baseline assessment, participants will be scheduled to receive the face-to-face virtual intervention followed by two weeks of EMA/EMI via mPRO. At the end of the two weeks, Veterans will complete a post-intervention assessment appointment. The post-intervention assessment includes an exit interview for participants to provide additional feedback regarding acceptability of the intervention. Follow-up assessment appointments will be completed at the 1-month and 3-month follow-ups.
Interventions
BEHAVIORALBrief Enhanced Anxiety Sensitivity Treatment
BEAST is a CBT-based intervention that includes psychoeducation, identifying and challenging maladaptive thoughts, and interoceptive exposure. The intervention is delivered through a single virtual face-to-face session supplemented with a mobile app for two weeks after the face to face session.
Sponsors
VA Office of Research and Development
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
No masking will occur as this is a one-arm trial.
Intervention model description
Participants will all be enrolled to receive the active intervention, Brief Enhanced Anxiety Sensitivity Treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Are English-speaking * Score equal to or greater than 9 on the SSASI indicating elevated anxiety sensitivity * Score equal to or greater than 5 on the WHODAS 2.0
Exclusion criteria
* Veterans with cognitive impairment as measured scoring equal to or greater than 11 on the Blessed * Orientation-Memory-Concentration Test * Veterans without access to a smartphone * Veterans with significant medical or psychiatric conditions that may limit participation, including: * severe documented schizophrenia * an ongoing active psychotic or manic state * an imminent suicide crisis will be excluded from our study and provided the appropriate referral
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Anxiety Sensitivity | From baseline to post-intervention (two-weeks after virtual treatment session) | Anxiety sensitivity will be measured via the Anxiety Sensitivity Index-3, an 18-item self-report measure assessing fear of negative consequences of anxiety-related symptoms. Scores range from 0 to 72 with higher scores indicating worse anxiety sensitivity. |
| Program Satisfaction | Post-intervention (two weeks after virtual treatment session) | Program satisfaction will be measured using an adapted 11-item version of the Program Satisfaction Questionnaire that assesses both general program satisfaction (usefulness, acceptability) and perceived utility of program components (psychoeducation, EMA/EMI schedule). Average scores range from 1 to 5 with higher scores indicating greater satisfaction. |
| Mean Change in Functional Impairment | From baseline to post-intervention (two-weeks after virtual treatment session) | Functional impairment will be measured using the 12-item version of the World Health Organization Disability Assessment 2.0. This scale assesses functional impairment across six domains: 1) understanding and communication, 2) self-care, 3) mobility, 4) interpersonal relationships, 5) work and household roles, and 6) community and civic roles. Scores range from 0 to 48 with higher scores indicating worse functional impairment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Changes in Functional Impairment Due to the COVID-19 Pandemic | From baseline to follow-up (measured six weeks after intervention session) | Functional Impairment Due to COVID ScaleA 7-item measure adapted from the WHODAS 2.0 to capture difficulties in functioning due to the COVID-19 pandemic. Scores range from 0 to 28 with higher scores indicating worse outcomes. |
| Mean Changes in Anxiety | From baseline to follow-up (measured six weeks after intervention session) | Changes in anxiety will be measured using the 8-item PROMIS anxiety short form. Scores range from 8 to 40 with higher scores indicating worse outcome. |
| Mean Change in Depression | From baseline to follow-up (measured six weeks after intervention session) | Changes in depression will be measured using the 4-item depression scale from the PROMIS Profile-29. The scores range from 4-20 with higher scores indicating worse outcomes. |
| Mean Changes in Worry Related to the COVID-19 Pandemic | From baseline to follow-up (measured six weeks after intervention session) | Worry related to the pandemic will be measured using the Coronavirus Impact Battery - Worry Scale. This scale is an 11-item scale measuring distress and worry due to the COVID-19 pandemic. Scores range from 0 to 44 with higher scores indicating worse outcome. |
| Mean Changes in Avoidance Due to the COVID-19 Pandemic | From baseline to follow-up (measured six weeks after intervention session) | Avoidance due to the pandemic will be measured using the Coronavirus Impact Battery - Behavior Scales, a 12-item scale assessing avoidance behaviors in relation to the COVID-19 pandemic. Scores range from 0 to 48 with higher scores indicating worse outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BEAST Condition A one-session intervention that can be delivered effectively by a clinician via telehealth and supplemented with a mobile app to provide opportunities to practice the skills learned in the face-to-face session.
Brief Enhanced Anxiety Sensitivity Treatment: BEAST is a CBT-based intervention that includes psychoeducation, identifying and challenging maladaptive thoughts, and interoceptive exposure. The intervention is delivered through a single virtual face-to-face session supplemented with a mobile app for two weeks after the face to face session. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | BEAST Condition |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 55.87 years STANDARD_DEVIATION 5.91 |
| Education Associates/Technical | 3 Participants |
| Education Four-Year College | 3 Participants |
| Education High School Diploma | 3 Participants |
| Education Master's Degree | 5 Participants |
| Education Professional Degree | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Marital Status Divorced/Separated | 4 Participants |
| Marital Status Married or Living with Partner | 7 Participants |
| Marital Status Single/Never Married | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 15 Participants |
| Served During Gulf War Did not Serve during Gulf War | 9 Participants |
| Served During Gulf War Served during Gulf War | 6 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Mean Change in Anxiety Sensitivity
Anxiety sensitivity will be measured via the Anxiety Sensitivity Index-3, an 18-item self-report measure assessing fear of negative consequences of anxiety-related symptoms. Scores range from 0 to 72 with higher scores indicating worse anxiety sensitivity.
Time frame: From baseline to post-intervention (two-weeks after virtual treatment session)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BEAST Condition | Mean Change in Anxiety Sensitivity | -11.15 score on a scale | Standard Deviation 13.89 |
Primary
Mean Change in Functional Impairment
Functional impairment will be measured using the 12-item version of the World Health Organization Disability Assessment 2.0. This scale assesses functional impairment across six domains: 1) understanding and communication, 2) self-care, 3) mobility, 4) interpersonal relationships, 5) work and household roles, and 6) community and civic roles. Scores range from 0 to 48 with higher scores indicating worse functional impairment.
Time frame: From baseline to post-intervention (two-weeks after virtual treatment session)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BEAST Condition | Mean Change in Functional Impairment | -7.38 score on a scale | Standard Deviation 10.94 |
Primary
Program Satisfaction
Program satisfaction will be measured using an adapted 11-item version of the Program Satisfaction Questionnaire that assesses both general program satisfaction (usefulness, acceptability) and perceived utility of program components (psychoeducation, EMA/EMI schedule). Average scores range from 1 to 5 with higher scores indicating greater satisfaction.
Time frame: Post-intervention (two weeks after virtual treatment session)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BEAST Condition | Program Satisfaction | 3.95 score on a scale | Standard Deviation 0.77 |
Secondary
Mean Change in Depression
Changes in depression will be measured using the 4-item depression scale from the PROMIS Profile-29. The scores range from 4-20 with higher scores indicating worse outcomes.
Time frame: From baseline to follow-up (measured six weeks after intervention session)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BEAST Condition | Mean Change in Depression | -2.92 score on a scale | Standard Deviation 2.72 |
Secondary
Mean Changes in Anxiety
Changes in anxiety will be measured using the 8-item PROMIS anxiety short form. Scores range from 8 to 40 with higher scores indicating worse outcome.
Time frame: From baseline to follow-up (measured six weeks after intervention session)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BEAST Condition | Mean Changes in Anxiety | -6.62 score on a scale | Standard Deviation 8.42 |
Secondary
Mean Changes in Avoidance Due to the COVID-19 Pandemic
Avoidance due to the pandemic will be measured using the Coronavirus Impact Battery - Behavior Scales, a 12-item scale assessing avoidance behaviors in relation to the COVID-19 pandemic. Scores range from 0 to 48 with higher scores indicating worse outcome.
Time frame: From baseline to follow-up (measured six weeks after intervention session)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BEAST Condition | Mean Changes in Avoidance Due to the COVID-19 Pandemic | -.15 score on a scale | Standard Deviation 8.51 |
Secondary
Mean Changes in Functional Impairment Due to the COVID-19 Pandemic
Functional Impairment Due to COVID ScaleA 7-item measure adapted from the WHODAS 2.0 to capture difficulties in functioning due to the COVID-19 pandemic. Scores range from 0 to 28 with higher scores indicating worse outcomes.
Time frame: From baseline to follow-up (measured six weeks after intervention session)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BEAST Condition | Mean Changes in Functional Impairment Due to the COVID-19 Pandemic | -1.58 score on a scale | Standard Deviation 4.5 |
Secondary
Mean Changes in Worry Related to the COVID-19 Pandemic
Worry related to the pandemic will be measured using the Coronavirus Impact Battery - Worry Scale. This scale is an 11-item scale measuring distress and worry due to the COVID-19 pandemic. Scores range from 0 to 44 with higher scores indicating worse outcome.
Time frame: From baseline to follow-up (measured six weeks after intervention session)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BEAST Condition | Mean Changes in Worry Related to the COVID-19 Pandemic | -9.67 score on a scale | Standard Deviation 13.34 |