Clinical trial NCT05554718: Evaluation of a Smartphone Application for Self-help for Social Anxiety
Official title: Evaluation of a Smartphone Application for Self-help for Patients With Social Anxiety Disorder: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Social Anxiety
Lead sponsor: Goethe University
Sponsor class: OTHER
Collaborators: name: Technische Universität Dresden
name: Mindable Health GmbH
First posted: 2022-09-26
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison of self-help app only, self-help app plus accompanying therapy sessions, and waitlist control group
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in SAD-related symptom severity measured by the Liebowitz Social Anxiety Scale
timeFrame: change from baseline (week 0) to week 12 (post) and to week 36 (follow-up)
Secondary outcomes:
measure: Change in SAD-related symptoms measured by the Social Phobia Inventory (SPIN)
timeFrame: change from baseline to week 12 (post) and to week 36 (follow-up)
measure: Change in the Social Phobic Cognition Questionnaire (SPK)
timeFrame: change from baseline to week 12 (post) and to week 36 (follow-up)
measure: Pain and Disability Index (PDI)
timeFrame: change from baseline to week 12 (post) and to week 36 (follow-up)
measure: Beck Depression Inventory - Fast Screen (BDI-FS)
timeFrame: change from baseline to week 12 (post) and to week 36 (follow-up)
measure: World Health Organization Quality of Life (WHO-QOL-BREF)
timeFrame: change from baseline to week 12 (post) and to week 36 (follow-up)
measure: Brief Symptom Inventory - 18-item version (BSI-18)
timeFrame: change from baseline to week 12 (post) and to week 36 (follow-up)
measure: Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS)
timeFrame: change from baseline to week 12 (post) and to week 36 (follow-up)
measure: Social Pain Questionnaire-5 (SPQ-5)
timeFrame: baseline measurement only (week 0) before intervention starts
measure: Self-developed question regarding skills in using the Internet
timeFrame: baseline measurement only (week 0) before intervention starts
measure: self-developed question regarding the attitude towards online interventions
timeFrame: baseline measurement only (week 0) before intervention starts
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: Only post measurement (week 12)
measure: Self-developed questionnaire on negative effects of treatment
timeFrame: Only post measurement (week 12)
measure: Clinical Global Impression (CGI)
timeFrame: change from baseline to week 12 (post) and to week 36 (follow-up)
measure: Quick Inventory of Depressive Symptoms (QIDS-C)
timeFrame: change from baseline to week 12 (post) and to week 36 (follow-up)
measure: Structured Clinical Interview for DSM 5 SCID-V-CV
timeFrame: change from baseline to week 12 (post) and to week 36 (follow-up)
measure: Modified version of the Social Phobia Weekly Summary Scale (SPWSS)
timeFrame: 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)
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Technische Universitaet Dresden
city: Frankfurt
country: Germany
facility: Goethe Universitaet Frankfurt
Study officials:
affiliation: Goethe University Frankfurt
name: Ulrich Stangier, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Technische Universitaet Dresden
name: Jürgen Hoyer, Professor
role: PRINCIPAL_INVESTIGATOR
References: