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

September 16, 2022 updated by: Goethe University

Evaluation of a Smartphone Application for Self-help for Patients With Social Anxiety Disorder: a Randomized Controlled Study

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
165

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
      • Dresden, Germany, 01187
        • Recruiting
        • Technische Universitaet Dresden
        • Contact:
      • Frankfurt, Germany, 60486

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: App condition
All participants will receive access to the developed social anxiety disorder (SAD) treatment app for 12 weeks.
Behavioral: 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.
Experimental: 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.
Behavioral: 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.
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.
No Intervention: Waitlist control condition
Delayed use of the mobile application after 12 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in SAD-related symptom severity measured by the Liebowitz Social Anxiety Scale
Time Frame: change from baseline (week 0) to week 12 (post) and to week 36 (follow-up)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in SAD-related symptoms measured by the Social Phobia Inventory (SPIN)
Time Frame: change from baseline to week 12 (post) and to week 36 (follow-up)
The SPIN is a self-report questionnaire designed to assess the amount of discomfort in different situations during the last week. The scale ranges from 0 ("not at all") to 4 ("extremely"). The total score ranges from 0 to 68, with higher scores indicating more severe symptoms of social anxiety.
change from baseline to week 12 (post) and to week 36 (follow-up)
Change in the Social Phobic Cognition Questionnaire (SPK)
Time Frame: change from baseline to week 12 (post) and to week 36 (follow-up)
The SPK lists 22 SAD-related beliefs that are rated on two scales: thought frequency, ranging from 1 ("thought never occurs") to 5 ("thought always occurs") and belief rating, ranging from 0 ("I do not believe this thought") to 100 ("I am completely convinced this thought is true"). Higher scores indicate more SAD-related beliefs.
change from baseline to week 12 (post) and to week 36 (follow-up)
Pain and Disability Index (PDI)
Time Frame: change from baseline to week 12 (post) and to week 36 (follow-up)
The PDI measures the amount of impairment and distress caused by the mental illness. It consists of 7 different categories (e.g., "Social Activity") that are rated on a scale fom 0 ("no disability") to 10 ("total disability"). Higher scores indicating higher levels of disability.
change from baseline to week 12 (post) and to week 36 (follow-up)
Beck Depression Inventory - Fast Screen (BDI-FS)
Time Frame: change from baseline to week 12 (post) and to week 36 (follow-up)
The BDI-FS assesses symptoms of depression using 7 items on a 4-point scale, with higher scores indicating greater severity.
change from baseline to week 12 (post) and to week 36 (follow-up)
World Health Organization Quality of Life (WHO-QOL-BREF)
Time Frame: change from baseline to week 12 (post) and to week 36 (follow-up)
The WHO-QOL-BREF measures the overall quality of life and asks for ratings on varying 5-point-scales for different domains like physical health (e.g., "how satisfied are you with..."). Scores for each domain are transformed to a scale of 0 to 100, with higher overall scores indicating a higher quality of life.
change from baseline to week 12 (post) and to week 36 (follow-up)
Brief Symptom Inventory - 18-item version (BSI-18)
Time Frame: change from baseline to week 12 (post) and to week 36 (follow-up)
The BSI measures general psychological distress using 18 items like "feelings of loneliness" on a scale from 0 ("not at all") to 4 ("a lot").
change from baseline to week 12 (post) and to week 36 (follow-up)
Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS)
Time Frame: change from baseline to week 12 (post) and to week 36 (follow-up)
The ACIPS measures the pleasure a person experiences in a social situation with a total of 17 items. The items are rated on a scale from 1 ("very false for me") to 6 ("very true for me"), with higher total scores indicating higher interpersonal pleasure.
change from baseline to week 12 (post) and to week 36 (follow-up)
Social Pain Questionnaire-5 (SPQ-5)
Time Frame: baseline measurement only (week 0) before intervention starts
Sensitivity to rejection in social situations are assessed with the Social Pain Questionnaire (SPQ-5). The questionnaire consists of 5 items rating from 0 ("describes me perfectly") to 4 ("not at all"). Higher total scores indicate higher social pain.
baseline measurement only (week 0) before intervention starts
Self-developed question regarding skills in using the Internet
Time Frame: baseline measurement only (week 0) before intervention starts
A single question assesses participants' ability to use smartphone apps on a scale of 0 to 100, with higher scores indicating greater ability to use apps on the smartphone. We hypothesize that this variable could moderate the outcome effects.
baseline measurement only (week 0) before intervention starts
self-developed question regarding the attitude towards online interventions
Time Frame: baseline measurement only (week 0) before intervention starts
To assess a person's attitude toward online circumvention, a question is asked that is rated on a scale of 0 ("not helpful at all") to 100 ("extremely helpful"), with higher scores indicating higher positive expectations. We hypothesize that this variable could moderate the outcome effects.
baseline measurement only (week 0) before intervention starts
Client Satisfaction Questionnaire (CSQ)
Time Frame: Only post measurement (week 12)
Treatment satisfaction will be measured by using the Client Satisfaction Questionnaire (CSQ), which we adapted slightly to match the use of the app. The questionnaire consists of 8 questions rated on a scale from 1 ("not at all") to 4 ("definitely yes").
Only post measurement (week 12)
Self-developed questionnaire on negative effects of treatment
Time Frame: Only post measurement (week 12)
Drawing on the results of Boettcher et al., we developed a brief (7-item) scale with items covering the negative side effects that were considered most relevant by a group of experts. The items are rated on a scale from 0 ("do not agree at all") to 5 ("fully agree"). Please note, that the descriptive list of possible side effects is preliminary and may be slightly revised after the pilot study. As the list contains an open item, responses to this item will be evaluated after the pilot study and inclusion of further side effects in the list is possible should they be mentioned frequently.
Only post measurement (week 12)
Clinical Global Impression (CGI)
Time Frame: change from baseline to week 12 (post) and to week 36 (follow-up)
The CGI-Severity scale provides information about the current severity of social phobic symptoms which are rated on a 7-step scale from "normal" or "not ill at all" to "among the most severely ill patients" by a clinician. The CGI-Improvement scale is a 7-point scale rating the change in symptom severity from 'improved by a lot' to 'a lot worse'. The use of the CGI, as a measure for symptom-specific improvement for patients with SAD, is supported by adequate psychometric properties and its practicability.
change from baseline to week 12 (post) and to week 36 (follow-up)
Quick Inventory of Depressive Symptoms (QIDS-C)
Time Frame: change from baseline to week 12 (post) and to week 36 (follow-up)
The Quick Inventory of Depressive Symptomatology (QIDS-C) is a 16-item rating instrument for the assessment of depressive symptoms by an independent interviewer.
change from baseline to week 12 (post) and to week 36 (follow-up)
Structured Clinical Interview for DSM 5 SCID-V-CV
Time Frame: change from baseline to week 12 (post) and to week 36 (follow-up)
Structured interview providing a formal diagnosis. Psychometric properties showed good reliability and specificity.
change from baseline to week 12 (post) and to week 36 (follow-up)
Modified version of the Social Phobia Weekly Summary Scale (SPWSS)
Time Frame: weekly questionnaire from baseline to week 12 (post), as well as assessments at baseline, 6 weeks (mid), 12 weeks (post), and 36 weeks (follow-up)
Social anxiety and social approach behavior will be measured using a modified version of the Social Phobia Weekly Summary Scale (SPWSS). The individual points are rated on a scale from 0 to 100, with higher values indicating a higher rating of the respective item.
weekly questionnaire from baseline to week 12 (post), as well as assessments at baseline, 6 weeks (mid), 12 weeks (post), and 36 weeks (follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Goethe University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Technische Universität Dresden
Mindable Health GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ulrich Stangier, Professor, Goethe University Frankfurt
  • Principal Investigator: Jürgen Hoyer, Professor, Technische Universitaet Dresden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SoPho-App-Evaluation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The data used in this study is available from the corresponding authors upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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