Social AnxietySMASHNCT05554718
Evaluation of a Smartphone Application for Self-help for Social Anxiety
A study testing Self-help Smartphone App and Therapist-guided App Use in people with Social Anxiety, run by Goethe University at 2 sites in Germany.
Trial summary
The present study examines whether a self-help app can reduce symptoms of social anxiety disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Social Anxiety
- What is being tested?
- Self-help Smartphone App and Therapist-guided App Use
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 2 sitesGermany
- Study dates
- Oct 2022to Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Acute suicidality
- Active substance abuse or dependence
- Severe medical conditions (e.g., chronic cardiovascular disease)
- Severe depression
- Psychotic disorder
- Bipolar disorder
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- Borderline personality disorder
- Current psychotherapeutic treatment
- Current psychopharmacological treatment
- No proficient skills in the German language
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Technische Universitaet Dresden
Dresden, 01187
Jürgen Hoyer, Professor, +49 351 - 463-36986, Juergen.Hoyer@tu-dresden.de
- Recruiting
Goethe Universitaet Frankfurt
Frankfurt, 60486
Ulrich Stangier, Professor, +49 69 - 798-22848, stangier@psych.uni-frankfurt.de
About this study
Official title: 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.
Read the 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.
- Conditions
- Social Anxiety
- Being tested
- Self-help Smartphone App, Therapist-guided App Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-help Smartphone AppBehavioural
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 UseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| App condition | Experimental | All participants will receive access to the developed social anxiety disorder (SAD) treatment app for 12 weeks. Receives: 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. Receives: Behavioral: Self-help Smartphone App; Behavioral: Therapist-guided App Use |
| Waitlist control condition | No intervention | Delayed use of the mobile application after 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: change from baseline to week 12 (post) and to week 36 (follow-up)
Change in the Social Phobic Cognition Questionnaire (SPK)
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.
Measured: change from baseline to week 12 (post) and to week 36 (follow-up)
Pain and Disability Index (PDI)
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.
Measured: change from baseline to week 12 (post) and to week 36 (follow-up)
Beck Depression Inventory - Fast Screen (BDI-FS)
The BDI-FS assesses symptoms of depression using 7 items on a 4-point scale, with higher scores indicating greater severity.
Measured: change from baseline to week 12 (post) and to week 36 (follow-up)
World Health Organization Quality of Life (WHO-QOL-BREF)
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.
Measured: change from baseline to week 12 (post) and to week 36 (follow-up)
Brief Symptom Inventory - 18-item version (BSI-18)
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").
Measured: change from baseline to week 12 (post) and to week 36 (follow-up)
Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS)
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.
Measured: change from baseline to week 12 (post) and to week 36 (follow-up)
Social Pain Questionnaire-5 (SPQ-5)
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.
Measured: baseline measurement only (week 0) before intervention starts
Self-developed question regarding skills in using the Internet
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.
Measured: baseline measurement only (week 0) before intervention starts
self-developed question regarding the attitude towards online interventions
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.
Measured: baseline measurement only (week 0) before intervention starts
Client Satisfaction Questionnaire (CSQ)
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").
Measured: Only post measurement (week 12)
Self-developed questionnaire on negative effects of treatment
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.
Measured: Only post measurement (week 12)
Clinical Global Impression (CGI)
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.
Measured: change from baseline to week 12 (post) and to week 36 (follow-up)
Quick Inventory of Depressive Symptoms (QIDS-C)
The Quick Inventory of Depressive Symptomatology (QIDS-C) is a 16-item rating instrument for the assessment of depressive symptoms by an independent interviewer.
Measured: change from baseline to week 12 (post) and to week 36 (follow-up)
Structured Clinical Interview for DSM 5 SCID-V-CV
Structured interview providing a formal diagnosis. Psychometric properties showed good reliability and specificity.
Measured: change from baseline to week 12 (post) and to week 36 (follow-up)
Modified version of the Social Phobia Weekly Summary Scale (SPWSS)
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study startOct 2022 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison of self-help app only, self-help app plus accompanying therapy sessions, and waitlist control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Collaborators
- Technische Universität Dresden, Mindable Health GmbH
- Responsible party
- Sponsor
- Investigators
- Ulrich Stangier, Professor, Principal investigator, Goethe University FrankfurtJürgen Hoyer, Professor, Principal investigator, Technische Universitaet Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554718
- Sponsor's protocol ID
- SoPho-App-Evaluation
- Acronym
- SMASH
- Status last verified
- Sep 2022
- First submitted
- 12 Sep 2022
- Last updated
- 26 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data used in this study is available from the corresponding authors upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Smartphone Application for Self-help for Patients With Social Anxiety Disorder: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05554718
- Acronym / sponsor ID
- SMASH / SoPho-App-Evaluation
- Conditions
- Social Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Collaborators
- Technische Universität Dresden, Mindable Health GmbH
- Study start
- Oct 2022 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 26 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study examines whether a self-help app can reduce symptoms of social anxiety disorder.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Comparison of self-help app only, self-help app plus accompanying therapy sessions, and waitlist control group
| Arm | Type | Receives |
|---|---|---|
| App condition | Experimental | Behavioral: Self-help Smartphone AppAll participants will receive access to the developed social anxiety disorder (SAD) treatment app for 12 weeks. |
| App with accompanying therapy sessions | Experimental | Behavioral: Self-help Smartphone App, Behavioral: Therapist-guided App UseIn 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. |
| Waitlist control condition | No intervention | –Delayed use of the mobile application after 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- Acute suicidality
- Active substance abuse or dependence
- Severe medical conditions (e.g., chronic cardiovascular disease)
- Severe depression
- Psychotic disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-help Smartphone AppThe 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. | Behavioural | App condition, App with accompanying therapy sessions |
| Therapist-guided App UseIn 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. | Behavioural | App with accompanying therapy sessions |
Primary outcome
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.
16 secondary outcomes
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)
Change in the Social Phobic Cognition Questionnaire (SPK)
Time frame: 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)
Beck Depression Inventory - Fast Screen (BDI-FS)
Time frame: 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)
Brief Symptom Inventory - 18-item version (BSI-18)
Time frame: 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)
Social Pain Questionnaire-5 (SPQ-5)
Time frame: 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
self-developed question regarding the attitude towards online interventions
Time frame: baseline measurement only (week 0) before intervention starts
Client Satisfaction Questionnaire (CSQ)
Time frame: Only post measurement (week 12)
Self-developed questionnaire on negative effects of treatment
Time frame: Only post measurement (week 12)
Clinical Global Impression (CGI)
Time frame: 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)
Structured Clinical Interview for DSM 5 SCID-V-CV
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
- Individual participant dataSharing planned: Yes. The data used in this study is available from the corresponding authors upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrich Stangier, Professor principal investigator
Goethe University Frankfurt
Jürgen Hoyer, Professor principal investigator
Technische Universitaet Dresden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-help Smartphone App and Therapist-guided App Use in people with Social Anxiety, run by Goethe University at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ulrich Stangier, Professor (+49 69 - 798-22848, stangier@psych.uni-frankfurt.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2022.