Text-Based Intervention for Social Anxiety

Overseen By Sarah Szafranski

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Psychiatric hospitalization, Detoxification, Suicide attempt, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new text-based treatment called DSB-I to help Veterans manage social anxiety as they return to work. The goal is to determine if supportive text messages can reduce anxiety-related behaviors that make social and work situations challenging. Veterans in Compensated Work Therapy who often feel anxious in social settings may be suitable for this trial. Participants will receive text messages through a program called ANNIE for 30 days to assess improvements in their work and social life. As an unphased trial, this study offers Veterans the chance to explore innovative support methods for managing social anxiety.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this text-based intervention is safe for Veterans?

Research has shown that text-based treatments for social anxiety are generally safe. One study compared different therapies for social anxiety and reported no negative effects, indicating that these treatments are usually well-tolerated. As this type of treatment undergoes testing for social anxiety, current evidence suggests it is a safe option. However, as with any treatment, participants should monitor personal effects if they choose to participate. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for social anxiety, such as cognitive-behavioral therapy or medications like SSRIs, DSB-I is administered through a text-based intervention. This innovative approach uses ANNIE, a platform that delivers supportive and therapeutic messages directly to users' phones over 30 days. Researchers are excited about this method because it offers a convenient and discreet way for individuals to receive help, potentially increasing accessibility and adherence compared to in-person therapy sessions. Additionally, this type of intervention could provide immediate support in real-time, which is a unique advantage over traditional options.

What evidence suggests that this text-based intervention is effective for social anxiety?

Research has shown that text-based programs can help reduce social anxiety. In one study, a group using this type of program improved at a higher rate (39%) compared to those using traditional talk therapy (15%). Another study found that similar online methods significantly reduced anxiety symptoms in university students. These results suggest that the DSB-I program, which participants in this trial will receive, might effectively lower social anxiety symptoms, helping people feel and function better in social and work situations. ^{2 6 7 8 9}

Who Is on the Research Team?

Anouk L. Grubaugh, PhD MA BS

Principal Investigator

Ralph H. Johnson VA Medical Center, Charleston, SC

Are You a Good Fit for This Trial?

This trial is for Veterans with social anxiety who are enrolled in Compensated Work Therapy, scoring above specific thresholds on the Social Phobia Inventory and Subtle Avoidance Frequency Examination. It's not open to those recently hospitalized for psychiatric reasons, detoxified, attempted suicide, or in another related study.

Inclusion Criteria

Active enrollment in Compensated Work Therapy

Score of > 47 on the Subtle Avoidance Frequency Examination

Score of > 25 on the Social Phobia Inventory

Exclusion Criteria

Recent (<3 month) history of psychiatric hospitalization, detoxification admission, or suicide attempt

Concurrent enrollment in another study related to social anxiety or improving functional status

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a text message intervention via ANNIE for 30 days to reduce social anxiety related safety behaviors

4 weeks

Text-based intervention

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DSB-I

Trial Overview The study tests a brief text-based intervention called DSB-I aimed at reducing safety behaviors that people with social anxiety use. The goal is to help these individuals better reintegrate into the workforce by improving their functional outcomes and quality of life.

How Is the Trial Designed?

Group I: DSB-Intervention Experimental Treatment 1 Intervention

Active intervention group receives text message intervention via ANNIE for 30 days

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Ralph H. Johnson VA Medical Center

Collaborator

Trials

21

Recruited

5,700+

Published Research Related to This Trial

A study involving 42 participants showed that both an Internet-based cognitive-behavior therapy for social anxiety disorder (SAD) with and without therapist support significantly reduced SAD symptoms and improved quality of life.

While both treatment groups had similar outcomes, the group receiving therapist support had lower dropout rates (20% vs. 50%), suggesting that having a therapist may help keep participants engaged in the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Delivered Acceptance-Based Cognitive-Behavioral Intervention for Social Anxiety Disorder With and Without Therapist Support: A Randomized Trial. Gershkovich, M., Herbert, JD., Forman, EM., et al.[2018]

The computer-administered versions of the Liebowitz Social Anxiety Scale (LSAS) and the Brief Social Phobia Scale (BSPS) demonstrated high reliability and validity, showing strong correlations with traditional clinician-administered versions throughout the study.

Seventy-seven percent of participants felt the computer did not interfere with their visit, and a significant portion preferred the computer method, indicating that these digital scales can be a reliable and cost-effective alternative for assessing social anxiety in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-administered rating scales for social anxiety in a clinical drug trial. Kobak, KA., Schaettle, SC., Greist, JH., et al.[2019]

Individuals with social anxiety disorder (SAD) preferred using voice/text mediums over visual mediums for social interactions, but using visual mediums led to immediate increases in positive perceptions and emotions.

The study, which involved 88 participants over 21 days, suggests that incorporating visual mediums into exposure interventions could enhance emotional responses and perceptions in individuals with SAD, potentially aiding in their treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Medium is the Message: Effects of Mediums of Communication on Perceptions and Emotions in Social Anxiety Disorder. Oren-Yagoda, R., Aderka, IM.[2021]

A study involving 52 participants with social anxiety disorder found that mobile phone-based cognitive behavior therapy (mCBT) was significantly more effective than mobile interpersonal psychotherapy (mIPT), with a Cohen's d of 0.64 favoring mCBT.

At post-treatment, 55.6% of participants in the mCBT group were classified as responders, compared to only 8.0% in the mIPT group, indicating that mCBT is a promising and effective treatment option for social anxiety disorder delivered through modern technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavior therapy versus interpersonal psychotherapy for social anxiety disorder delivered via smartphone and computer: a randomized controlled trial. Dagöö, J., Asplund, RP., Bsenko, HA., et al.[2018]

In a pilot randomized controlled trial involving 38 outpatients with social anxiety disorder, both systemic therapy (ST) and cognitive behavioral therapy (CBT) significantly reduced social anxiety levels, with ST showing a greater effect size (d = 0.81) compared to CBT.

The remission rates were notably higher in the ST group (39%) compared to the CBT group (15%), indicating that ST may be a more effective treatment option for social anxiety disorder, with no reported adverse events during the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing Cognitive Behavioral Therapy and Systemic Therapy for Social Anxiety Disorder: Randomized Controlled Pilot Trial (SOPHO-CBT/ST). Hunger, C., Hilzinger, R., Klewinghaus, L., et al.[2021]

A randomized controlled trial involving 38 clients with social anxiety disorder demonstrated that a manualized cognitive-behavioral treatment package led to significantly greater improvements in social anxiety and impairment compared to a delayed treatment group.

Improvements were maintained at a three-month follow-up, suggesting that this treatment approach is effective and could be a viable option for broader dissemination in managing social anxiety disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a manualized and workbook-driven individual treatment for social anxiety disorder. Ledley, DR., Heimberg, RG., Hope, DA., et al.[2022]

In a study of 91 patients with social anxiety disorder, adding semi-individualized e-mail support to cognitive behavioral group therapy (CBGT) improved treatment outcomes, especially for those at risk of dropping out.

Patients who received e-mail support showed greater reductions in symptom severity and tended to have lower dropout rates compared to those who only received CBGT, suggesting that this support can enhance therapy effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

E-mail support as an adjunct to cognitive-behavioral group therapy for social anxiety disorder: Impact on dropout and outcome. Delsignore, A., Rufer, M., Emmerich, J., et al.[2019]

A pilot study involving 24 adults with generalized social anxiety disorder (SAD) demonstrated that a 12-session acceptance-based behavioral intervention delivered via Skype was both feasible and acceptable to participants and therapists.

Participants showed significant improvements in social anxiety, depression, disability, quality of life, and experiential avoidance, with effect sizes comparable to or larger than traditional in-person cognitive behavioral therapy (CBT) for SAD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance based behavior therapy for social anxiety disorder through videoconferencing. Yuen, EK., Herbert, JD., Forman, EM., et al.[2019]

Remote cognitive behavior therapy (CBT) for social anxiety disorder (SAD) shows large effect sizes in improving symptoms, with a pooled effect size of 1.06 from pre-treatment to post-treatment based on 31 studies involving 2905 participants.

Remote CBT methods, including internet and application-delivered formats, are more effective than passive controls and non-CBT treatments, and are at least as effective as traditional face-to-face CBT, suggesting they can significantly enhance access to treatment for SAD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote cognitive behaviour therapy for social anxiety disorder: A meta-analysis. Winter, HR., Norton, AR., Burley, JL., et al.[2023]

Only about 20% of individuals with a history of social anxiety disorder (SAD) ever seek treatment, but among those who do, 65.1% find their treatment helpful after seeing multiple professionals.

Persistence in seeking treatment significantly increases the likelihood of finding helpful care, especially for individuals who consult mental health specialists and have multiple anxiety disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived helpfulness of treatment for social anxiety disorder: findings from the WHO World Mental Health Surveys. Bruffaerts, R., Harris, MG., Kazdin, AE., et al.[2023]

A new, comprehensive treatment for severe social phobia has shown effectiveness in a pilot study, particularly for individuals with co-occurring mental health conditions.

The treatment resulted in significant improvements across various outcome measures, highlighting the importance of a multifaceted approach to effectively address social phobia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multicomponent behavioral treatment for social phobia: social effectiveness therapy. Turner, SM., Beidel, DC., Cooley, MR., et al.[2019]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/10807462

grubaugh, anouk l - NIH RePORTER The proposed study seeks to evaluate the feasibility of implementing a brief text-based intervention for decreasing social anxiety related safety behaviors ...

2. withpower.com withpower.com/trial/phase-anxiety-disorders-11-2023-a91c5

Text-Based Intervention for Social Anxiety The remission rates were notably higher in the ST group (39%) compared to the CBT group (15%), indicating that ST may be a more effective treatment option for ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6329899/

Evaluating a Web-Based Social Anxiety Intervention ... The initial evaluation of Overcome Social Anxiety revealed that it led to significant reductions in symptom severity among university ...

4. revista.appsicologia.org revista.appsicologia.org/index.php/rpsicologia/article/download/1786/1065/7498

Outcomes from a brief group behavior therapy approach for ... This paper intends to explore the change in self-reported social anxiety, avoidance, and practice of safety behaviors, following a brief group ...

5. researchgate.net researchgate.net/publication/266619723_Improving_outcomes_in_social_anxiety_disorder

(PDF) Improving outcomes in social anxiety disorder PDF | On Oct 1, 2014, Pim Cuijpers and others published Improving outcomes in social anxiety disorder | Find, read and cite all the research you need on ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7611485/

Safety behaviours in social anxiety: an examination across ... We set out to investigate the factor structure of safety behaviours in relation to adolescent social anxiety symptoms and SAD, the extent to which this varies ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21831356/

Differential effects of safety behaviour subtypes in social ... Avoidance safety behaviours were associated with higher state anxiety during the interaction and negative reactions from participants' interaction partners.

8. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2022.987426/full

Serial mediating effects of state and trait post-event ... The cognitive model for social anxiety disorder (SAD) highlights the role of safety behaviors and post-event processing (PEP).

9. journals.plos.org journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0223165&type=printable

Sub-types of safety behaviours and their effects on social ... Cognitive models suggest that social anxiety disorder (SAD) is maintained through the use of safety behaviours.