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Evaluation of a Smartphone Application for Self-help for Social Anxiety (SMASH)

G

Goethe University

Status

Enrolling

Conditions

Social Anxiety

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05554718
SoPho-App-Evaluation

Details and patient eligibility

About

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

Full description

The study will test the effectiveness of a newly developed mobile app in treating patients with social anxiety. Participants will be randomly assigned to one of the following groups: app use only, therapist-guided app use, and a wait-list control group. Over a 12-week period, the study will examine whether mobile app use leads to significant reductions in symptoms associated with social anxiety, as well as improvements in secondary outcomes such as quality of life, depression, or psychological impairment.

Enrollment

165 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

165 participants in 3 patient groups

App condition
Experimental group
Description:
All participants will receive access to the developed social anxiety disorder (SAD) treatment app for 12 weeks.
Treatment:
Behavioral: Self-help Smartphone App
App with accompanying therapy sessions
Experimental group
Description:
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.
Treatment:
Behavioral: Therapist-guided App Use
Behavioral: Self-help Smartphone App
Waitlist control condition
No Intervention group
Description:
Delayed use of the mobile application after 12 weeks.

Trial contacts and locations

2

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Central trial contact

Ulrich Stangier, Professor; Juergen Hoyer, Professor

Data sourced from clinicaltrials.gov

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