Evaluation of a Smartphone Application for Self-help for Patients With Social Anxiety Disorder: a Randomized Controlled Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Social Anxiety
- Sponsor
- Goethe University
- Enrollment
- 165
- Locations
- 2
- Primary Endpoint
- Change in SAD-related symptom severity measured by the Liebowitz Social Anxiety Scale
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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))
- Change in the Social Phobic Cognition Questionnaire (SPK)(change from baseline to week 12 (post) and to week 36 (follow-up))
- Pain and Disability Index (PDI)(change from baseline to week 12 (post) and to week 36 (follow-up))
- Beck Depression Inventory - Fast Screen (BDI-FS)(change from baseline to week 12 (post) and to week 36 (follow-up))
- World Health Organization Quality of Life (WHO-QOL-BREF)(change from baseline to week 12 (post) and to week 36 (follow-up))
- Brief Symptom Inventory - 18-item version (BSI-18)(change from baseline to week 12 (post) and to week 36 (follow-up))
- Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS)(change from baseline to week 12 (post) and to week 36 (follow-up))
- Social Pain Questionnaire-5 (SPQ-5)(baseline measurement only (week 0) before intervention starts)
- Self-developed question regarding skills in using the Internet(baseline measurement only (week 0) before intervention starts)
- self-developed question regarding the attitude towards online interventions(baseline measurement only (week 0) before intervention starts)
- Client Satisfaction Questionnaire (CSQ)(Only post measurement (week 12))
- Self-developed questionnaire on negative effects of treatment(Only post measurement (week 12))
- Clinical Global Impression (CGI)(change from baseline to week 12 (post) and to week 36 (follow-up))
- Quick Inventory of Depressive Symptoms (QIDS-C)(change from baseline to week 12 (post) and to week 36 (follow-up))
- Structured Clinical Interview for DSM 5 SCID-V-CV(change from baseline to week 12 (post) and to week 36 (follow-up))
- 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))