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

Not Applicable

Recruiting

• Conditions: Social Anxiety
• Interventions: Behavioral: Self-help Smartphone App; Behavioral: Therapist-guided App Use

• Registration Number: NCT05554718
• Lead Sponsor: Goethe University

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.

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-12
• Study First Submitted QC: 2022-09-16
• Last Update Submitted: 2022-09-16
• Study First Posted: 2022-09-26
• Last Update Posted: 2022-09-26
• Study Start: 2022-10
• Primary Completion: 2023-10
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 165

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
App with accompanying therapy sessions	Therapist-guided App Use	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.
App condition	Self-help Smartphone App	All participants will receive access to the developed social anxiety disorder (SAD) treatment app for 12 weeks.
App with accompanying therapy sessions	Self-help Smartphone App	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.

Primary Outcome Measures

Name	Time	Method
Change in SAD-related symptom severity measured by the Liebowitz Social Anxiety Scale	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.

Secondary Outcome Measures

Name	Time	Method
Brief Symptom Inventory - 18-item version (BSI-18)	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 in SAD-related symptoms measured by the Social Phobia Inventory (SPIN)	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 in the Social Phobic Cognition Questionnaire (SPK)	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.
Pain and Disability Index (PDI)	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.
Beck Depression Inventory - Fast Screen (BDI-FS)	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.
World Health Organization Quality of Life (WHO-QOL-BREF)	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.
Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS)	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.
Social Pain Questionnaire-5 (SPQ-5)	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.
Self-developed question regarding skills in using the Internet	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.
self-developed question regarding the attitude towards online interventions	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.
Client Satisfaction Questionnaire (CSQ)	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").
Self-developed questionnaire on negative effects of treatment	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.
Clinical Global Impression (CGI)	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.
Quick Inventory of Depressive Symptoms (QIDS-C)	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.
Structured Clinical Interview for DSM 5 SCID-V-CV	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.
Modified version of the Social Phobia Weekly Summary Scale (SPWSS)	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.

Trial Locations

Locations (2)

Goethe Universitaet Frankfurt; 🇩🇪 Frankfurt, Germany

Technische Universitaet Dresden; 🇩🇪 Dresden, Germany