Evaluation of a Smartphone Application for Self-help for Social Anxiety

NCT05554718 | Unknown

• 1 other identifier: SoPho-App-Evaluation
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 2

Brief Summary

The present study examines whether a self-help app can reduce symptoms of social anxiety disorder.

Conditions

Social Anxiety

Outcome Measures

Primary Outcomes (1)

• Change in SAD-related symptom severity measured by the Liebowitz Social Anxiety Scale

  The LSAS is a clinician-rated interview designed to measure fear and avoidance in different social situations. The situations are rated on scale from 0 ("not at all" or "never") to 3 (severe" or "most of the time"), with higher scores indicating greater symptoms of social anxiety.

  change from baseline (week 0) to week 12 (post) and to week 36 (follow-up)

Secondary Outcomes (16)

• Change in SAD-related symptoms measured by the Social Phobia Inventory (SPIN)

  change from baseline to week 12 (post) and to week 36 (follow-up)

• Change in the Social Phobic Cognition Questionnaire (SPK)

  change from baseline to week 12 (post) and to week 36 (follow-up)

• Pain and Disability Index (PDI)

  change from baseline to week 12 (post) and to week 36 (follow-up)

• Beck Depression Inventory - Fast Screen (BDI-FS)

  change from baseline to week 12 (post) and to week 36 (follow-up)

• World Health Organization Quality of Life (WHO-QOL-BREF)

  change from baseline to week 12 (post) and to week 36 (follow-up)

Study Arms (3)

App condition

EXPERIMENTAL

All participants will receive access to the developed social anxiety disorder (SAD) treatment app for 12 weeks.

Behavioral: Self-help Smartphone App

App with accompanying therapy sessions

EXPERIMENTAL

In addition to being able to use the app to treat social anxiety over a 12-week period, participants will receive a total of 8 video therapy sessions based on cognitive behavioral therapy to accompany their use of the app.

Behavioral: Self-help Smartphone App; Behavioral: Therapist-guided App Use

Waitlist control condition

NO INTERVENTION

Delayed use of the mobile application after 12 weeks.

Interventions

Self-help Smartphone App BEHAVIORAL

The app provides a 12-week adaptation of scientifically proven cognitive behavioral therapy techniques for the treatment of SAD and is intended for use as a mobile intervention. The app includes modules such as learning (e.g., creating a model, learning about the maintaining factors), changing the maintaining factors (e.g., safety behaviors), or behavioral experiments.

App condition; App with accompanying therapy sessions

Therapist-guided App Use BEHAVIORAL

In addition to using the app, patients receive a total of 8 video-based therapy sessions over the course of 12 weeks. The sessions include topics such as video feedback and behavioral experiments.

App with accompanying therapy sessions

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current diagnosis of Social Anxiety Disorder
• Written informed consent before the start of the study
• Age: 18 to 65 years
• Possession of smartphone
• Familiarity with using smartphone apps

You may not qualify if:

• Acute suicidality
• Active substance abuse or dependence
• Severe medical conditions (e.g., chronic cardiovascular disease)
• Severe depression
• Psychotic disorder
• Bipolar disorder
• Borderline personality disorder
• Current psychotherapeutic treatment
• Current psychopharmacological treatment
• No proficient skills in the German language

Sponsors & Collaborators

• Goethe University: lead
• Technische Universität Dresden: collaborator
• Mindable Health GmbH: collaborator

Study Sites (2)

Technische Universitaet Dresden

Dresden, 01187, Germany

RECRUITING

Goethe Universitaet Frankfurt

Frankfurt, 60486, Germany

RECRUITING

Study Officials

• Ulrich Stangier, Professor

  Goethe University Frankfurt

  PRINCIPAL INVESTIGATOR

• Jürgen Hoyer, Professor

  Technische Universitaet Dresden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ulrich Stangier, Professor

CONTACT

+49 69 - 798-22848; stangier@psych.uni-frankfurt.de

Juergen Hoyer, Professor

CONTACT

+49 351 - 463-36986; Juergen.Hoyer@tu-dresden.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors are blinded to the conditions, but blinding of participant and care provider is not possible due to the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparison of self-help app only, self-help app plus accompanying therapy sessions, and waitlist control group

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 26, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: September 26, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share

Locations

DE (2)