Back to resultsEvaluation of a Smartphone Application for Self-help for Social Anxiety (SMASH)
Primary Purpose
Social Anxiety
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Self-help Smartphone App
Therapist-guided App Use
Sponsored by
About this trial
This is an interventional treatment trial for Social Anxiety
Eligibility Criteria
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
Sites / Locations
- Technische Universitaet DresdenRecruiting
- Goethe Universitaet FrankfurtRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
App condition
App with accompanying therapy sessions
Waitlist control condition
Arm Description
All participants will receive access to the developed social anxiety disorder (SAD) treatment app for 12 weeks.
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.
Delayed use of the mobile application after 12 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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").
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.
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.
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.
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.
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").
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.
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.
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.
Structured Clinical Interview for DSM 5 SCID-V-CV
Structured interview providing a formal diagnosis. Psychometric properties showed good reliability and specificity.
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.
Full Information
NCT ID
NCT05554718
First Posted
September 12, 2022
Last Updated
September 16, 2022
Sponsor
Goethe University
Collaborators
Technische Universität Dresden, Mindable Health GmbH
1. Study Identification
Unique Protocol Identification Number
NCT05554718
Brief Title
Evaluation of a Smartphone Application for Self-help for Social Anxiety
Acronym
SMASH
Official Title
Evaluation of a Smartphone Application for Self-help for Patients With Social Anxiety Disorder: a Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Goethe University
Collaborators
Technische Universität Dresden, Mindable Health GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Comparison of self-help app only, self-help app plus accompanying therapy sessions, and waitlist control group
Masking
Outcomes Assessor
Masking Description
Outcome assessors are blinded to the conditions, but blinding of participant and care provider is not possible due to the nature of the intervention.
Allocation
Randomized
Enrollment
165 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
App condition
Arm Type
Experimental
Arm Description
All participants will receive access to the developed social anxiety disorder (SAD) treatment app for 12 weeks.
Arm Title
App with accompanying therapy sessions
Arm Type
Experimental
Arm 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.
Arm Title
Waitlist control condition
Arm Type
No Intervention
Arm Description
Delayed use of the mobile application after 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Self-help Smartphone App
Intervention Description
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
Intervention Name(s)
Therapist-guided App Use
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in SAD-related symptom severity measured by the Liebowitz Social Anxiety Scale
Description
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.
Time Frame
change from baseline (week 0) to week 12 (post) and to week 36 (follow-up)
Secondary Outcome Measure Information:
Title
Change in SAD-related symptoms measured by the Social Phobia Inventory (SPIN)
Description
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.
Time Frame
change from baseline to week 12 (post) and to week 36 (follow-up)
Title
Change in the Social Phobic Cognition Questionnaire (SPK)
Description
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.
Time Frame
change from baseline to week 12 (post) and to week 36 (follow-up)
Title
Pain and Disability Index (PDI)
Description
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.
Time Frame
change from baseline to week 12 (post) and to week 36 (follow-up)
Title
Beck Depression Inventory - Fast Screen (BDI-FS)
Description
The BDI-FS assesses symptoms of depression using 7 items on a 4-point scale, with higher scores indicating greater severity.
Time Frame
change from baseline to week 12 (post) and to week 36 (follow-up)
Title
World Health Organization Quality of Life (WHO-QOL-BREF)
Description
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.
Time Frame
change from baseline to week 12 (post) and to week 36 (follow-up)
Title
Brief Symptom Inventory - 18-item version (BSI-18)
Description
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").
Time Frame
change from baseline to week 12 (post) and to week 36 (follow-up)
Title
Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS)
Description
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.
Time Frame
change from baseline to week 12 (post) and to week 36 (follow-up)
Title
Social Pain Questionnaire-5 (SPQ-5)
Description
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.
Time Frame
baseline measurement only (week 0) before intervention starts
Title
Self-developed question regarding skills in using the Internet
Description
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.
Time Frame
baseline measurement only (week 0) before intervention starts
Title
self-developed question regarding the attitude towards online interventions
Description
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.
Time Frame
baseline measurement only (week 0) before intervention starts
Title
Client Satisfaction Questionnaire (CSQ)
Description
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").
Time Frame
Only post measurement (week 12)
Title
Self-developed questionnaire on negative effects of treatment
Description
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.
Time Frame
Only post measurement (week 12)
Title
Clinical Global Impression (CGI)
Description
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.
Time Frame
change from baseline to week 12 (post) and to week 36 (follow-up)
Title
Quick Inventory of Depressive Symptoms (QIDS-C)
Description
The Quick Inventory of Depressive Symptomatology (QIDS-C) is a 16-item rating instrument for the assessment of depressive symptoms by an independent interviewer.
Time Frame
change from baseline to week 12 (post) and to week 36 (follow-up)
Title
Structured Clinical Interview for DSM 5 SCID-V-CV
Description
Structured interview providing a formal diagnosis. Psychometric properties showed good reliability and specificity.
Time Frame
change from baseline to week 12 (post) and to week 36 (follow-up)
Title
Modified version of the Social Phobia Weekly Summary Scale (SPWSS)
Description
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.
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ulrich Stangier, Professor
Phone
+49 69 - 798-22848
Email
stangier@psych.uni-frankfurt.de
First Name & Middle Initial & Last Name or Official Title & Degree
Juergen Hoyer, Professor
Phone
+49 351 - 463-36986
Email
Juergen.Hoyer@tu-dresden.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrich Stangier, Professor
Organizational Affiliation
Goethe University Frankfurt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jürgen Hoyer, Professor
Organizational Affiliation
Technische Universitaet Dresden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Technische Universitaet Dresden
City
Dresden
ZIP/Postal Code
01187
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jürgen Hoyer, Professor
Phone
+49 351 - 463-36986
Email
Juergen.Hoyer@tu-dresden.de
Facility Name
Goethe Universitaet Frankfurt
City
Frankfurt
ZIP/Postal Code
60486
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulrich Stangier, Professor
Phone
+49 69 - 798-22848
Email
stangier@psych.uni-frankfurt.de
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data used in this study is available from the corresponding authors upon reasonable request.
Learn more about this trial
Evaluation of a Smartphone Application for Self-help for Social Anxiety
We'll reach out to this number within 24 hrs