Exposure Initializes Therapy - Treatment Of Homebound Patients Extended

Not Applicable

• Conditions: Agoraphobia
• Interventions: Behavioral: cognitive behavioral therapy

• Registration Number: NCT04460378
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

Cognitive behavioral treatment of homebound patients with severe agoraphobia.

Detailed Description

Homebound patients with severe agoraphobia are treated with an exposure focussed cognitive behavioral therapy. The treatment begins at home. With a quick onset of guided exposure, patients get the possibility to develope the capability to reach the regular Treatment Location on their own very rapidly.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-03-22
• Status Verified: 2020-07
• Primary Completion: 2020-07-01
• Study First Submitted QC: 2020-07-01
• Last Update Submitted: 2020-07-01
• Study First Posted: 2020-07-07
• Last Update Posted: 2020-07-07
• Study Completion: 2020-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• agoraphobia with/without Panic disorder

Exclusion Criteria

• psychotic disorders
• bipolar disorders
• acute substance dependency

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cognitive Behavioral Therapy	cognitive behavioral therapy	Manualized Cognitive Behavioral Therapy starting at the patients' home.

Primary Outcome Measures

Name	Time	Method
MI	Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)	Mobility Inventory

Secondary Outcome Measures

Name	Time	Method
rs 13	Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)	Resilienzskala (resilience scale)
NEO-FFI	Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)	Persönlichkeitsfragebogen (personality inventory)
BSQ	Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)	Bosy Sensation Questionnaire
ASI	Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)	Angstsensitivität (anxiety sensitivity)
AKF	Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)	Angst-Kontroll-Fragebogen (anxiety control)
SWE	Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)	Selbstwirksamkeitsfragebogen (self-efficacy questionnaire)
UI18	Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)	Unsicherheitsintoleranz Fragebogen (intolerance of uncertainty questionnaire)
ACQ	Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)	Agoraphobic cognition questionnaire
BDI II	Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)	Beck Depression inventory II
alpha-amylase	change from baseline to follow up (+98 days)	daily profile of salivary alpha amylase
PSQ 20	Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)	perceived stress questionnaire
cortisol	change from baseline to follow up (+98 days)	daily profile of salivary cortisol
PAS	Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)	Panik- und Agoraphobie-Skala (Panic and agoraphobia scale)
EQ-5D	Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)	life quality questionnaire
AAQ II	Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)	Acceptance and Action questionnaire

Trial Locations

Locations (1)

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany