Social AnxietyNCT05996419
Intervention to Reduce Safety Behaviors
A study testing DSB-I in people with Social Anxiety, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Social anxiety is associated with significant deficits in social and occupational functioning. The proposed study seeks to evaluate the feasibility of implementing a brief text-based intervention for decreasing social anxiety related safety behaviors among Veterans attempting to re-integrate into the workforce. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Social Anxiety
- What is being tested?
- DSB-I
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 31 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active enrollment in Compensated Work Therapy
- Score of > 25 on the Social Phobia Inventory
- Score of > 47 on the Subtle Avoidance Frequency Examination
Who cannot join
- Concurrent enrollment in another study related to social anxiety or improving functional status
- Recent (<3 month) history of psychiatric hospitalization, detoxification admission, or suicide attempt
Trial locations and contacts
1 site in 1 country.
United States1 site
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5703
About this study
Official title: Improving Psychosocial Functioning Among Veterans With Social Anxiety: A Pilot Evaluation of Self-Monitoring Intervention to Reduce Safety Behaviors
Social anxiety is associated with significant deficits in social and occupational functioning. The proposed study seeks to evaluate the feasibility of implementing a brief text-based intervention for decreasing social anxiety related safety behaviors among Veterans attempting to re-integrate into the workforce. Findings from this pilot will support a larger randomized controlled study examining the efficacy of the intervention for improving functional outcomes and quality of life among Veterans.
- Conditions
- Social Anxiety
- Being tested
- DSB-I
- Keywords
- Veteran, Social Anxiety, workforce
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSB-IOther
Participant will receive text message every other day during active phase (30days) via ANNIE text messaging app related to the safety behaviors they identified prior to start.
| Study group | Role | What they receive |
|---|---|---|
| DSB-Intervention | Experimental | Active intervention group receives text message intervention via ANNIE for 30 days Receives: Other: DSB-I |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subtle Avoidance Frequency Examination (SAFE)
32-item self-report measure designed to assess the frequency of safety behavior (SB) use. Respondents are asked to rate how often they engage in SBs such as "Rehearse sentences in your mind" and "Avoid eye contact" on a scale of 0 (Never) to 4 (Always). Scores on the SAFE range from 0-128 with higher scores indicative or more safety behavior use. total mean score
Measured: Baseline and immediately after intervention
Social Phobia Inventory (SPIN)
17-item measure of social anxiety severity. Participants are asked to rate items such as "I avoid doing things or speaking to people for fear of embarrassment" on a Likert-type scale of 0 (Not at all) to 4 (Extremely). Scores on the SPIN range from 0 to 68 with higher scores indicative of more severe social anxiety, total mean score
Measured: baseline and immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start1 Jul 2024
- Primary completion28 Nov 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social AnxietyStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open trial
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Ralph H. Johnson VA Medical Center
- Responsible party
- Sponsor
- Investigators
- Anouk L. Grubaugh, PhD MA BS, Principal investigator, Ralph H. Johnson VA Medical Center, Charleston, SC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05996419
- Sponsor's protocol ID
- D4401-P
- Other IDs
- 121RX004401-01-A1
- Status last verified
- Jan 2026
- First submitted
- 9 Aug 2023
- Last updated
- 29 Oct 2026
- 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 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Psychosocial Functioning Among Veterans With Social Anxiety: A Pilot Evaluation of Self-Monitoring Intervention to Reduce Safety Behaviors
- ClinicalTrials.gov ID
- NCT05996419
- Acronym / sponsor ID
- D4401-P
- Conditions
- Social Anxiety
- Keywords
- Veteran, Social Anxiety, workforce
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Ralph H. Johnson VA Medical Center
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 28 Nov 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 18 Aug 2023 (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.
Social anxiety is associated with significant deficits in social and occupational functioning. The proposed study seeks to evaluate the feasibility of implementing a brief text-based intervention for decreasing social anxiety related safety behaviors among Veterans attempting to re-integrate into the workforce. Findings from this pilot will support a larger randomized controlled study examining the efficacy of the intervention for improving functional outcomes and quality of life among Veterans.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open trial
| Arm | Type | Receives |
|---|---|---|
| DSB-Intervention | Experimental | Other: DSB-IActive intervention group receives text message intervention via ANNIE for 30 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Active enrollment in Compensated Work Therapy
- Score of > 25 on the Social Phobia Inventory
- Score of > 47 on the Subtle Avoidance Frequency Examination
Key exclusion criteria (2 listed)
- Concurrent enrollment in another study related to social anxiety or improving functional status
- Recent (<3 month) history of psychiatric hospitalization, detoxification admission, or suicide attempt
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 |
|---|---|---|
| DSB-IParticipant will receive text message every other day during active phase (30days) via ANNIE text messaging app related to the safety behaviors they identified prior to start. | Other | DSB-Intervention |
Primary outcome
Subtle Avoidance Frequency Examination (SAFE)
Time frame: Baseline and immediately after intervention
32-item self-report measure designed to assess the frequency of safety behavior (SB) use. Respondents are asked to rate how often they engage in SBs such as "Rehearse sentences in your mind" and "Avoid eye contact" on a scale of 0 (Never) to 4 (Always). Scores on the SAFE range from 0-128 with higher scores indicative or more safety behavior use. total mean score
Social Phobia Inventory (SPIN)
Time frame: baseline and immediately after intervention
17-item measure of social anxiety severity. Participants are asked to rate items such as "I avoid doing things or speaking to people for fear of embarrassment" on a Likert-type scale of 0 (Not at all) to 4 (Extremely). Scores on the SPIN range from 0 to 68 with higher scores indicative of more severe social anxiety, total mean score
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 29 Oct 2026.
- 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.
Anouk L. Grubaugh, PhD MA BS principal investigator
Ralph H. Johnson VA Medical Center, Charleston, SC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DSB-I in people with Social Anxiety, run by VA Office of Research and Development 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 3 inclusion and 2 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 29 Oct 2026. 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?
Subtle Avoidance Frequency Examination (SAFE) (time frame: Baseline and immediately after intervention). The study lists 2 primary outcomes in all. 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 29 Oct 2026.