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

NCT ID: NCT05554718

Last Updated: 2022-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-31

Study Completion Date

2023-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Social Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Comparison of self-help app only, self-help app plus accompanying therapy sessions, and waitlist control group
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Outcome assessors are blinded to the conditions, but blinding of participant and care provider is not possible due to the nature of the intervention.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

App condition

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

Group Type EXPERIMENTAL

Self-help Smartphone App

Intervention Type 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 with accompanying therapy sessions

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.

Group Type EXPERIMENTAL

Self-help Smartphone App

Intervention Type 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.

Therapist-guided App Use

Intervention Type 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.

Waitlist control condition

Delayed use of the mobile application after 12 weeks.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Self-help Smartphone App

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.

Intervention Type BEHAVIORAL

Therapist-guided App Use

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Technische Universität Dresden

OTHER

Sponsor Role collaborator

Mindable Health GmbH

UNKNOWN

Sponsor Role collaborator

Goethe University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ulrich Stangier, Professor

Role: PRINCIPAL_INVESTIGATOR

Goethe University Frankfurt

Jürgen Hoyer, Professor

Role: PRINCIPAL_INVESTIGATOR

Technische Universitaet Dresden

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Technische Universitaet Dresden

Dresden, , Germany

Site Status RECRUITING

Goethe Universitaet Frankfurt

Frankfurt, , Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ulrich Stangier, Professor

Role: CONTACT

+49 69 - 798-22848

Juergen Hoyer, Professor

Role: CONTACT

+49 351 - 463-36986

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jürgen Hoyer, Professor

Role: primary

+49 351 - 463-36986

Ulrich Stangier, Professor

Role: primary

+49 69 - 798-22848

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SoPho-App-Evaluation

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Self-help Books for Social Anxiety
NCT03297619 COMPLETED NA
Self-help App and Wellbeing
NCT04911803 COMPLETED NA