Exposure Initializes Therapy - Treatment Of Homebound Patients Extended

Agoraphobia Clinical Trial

— ExITTOHoPE  

Official title:

Exposure Initializes Therapy - Treatment Of Homebound Patients Extended

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04460378
• Other study ID #: ChariteAmb
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: October 1, 2020

Study information

• Verified date: July 2020
• Source: Charite University, Berlin, Germany
• Contact: Jens Plag, Dr.
• Phone: +49 30 450 510 306
• Email: jens.plag[@]charite.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cognitive behavioral treatment of homebound patients with severe agoraphobia.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• agoraphobia with/without Panic disorder

Exclusion Criteria:

• psychotic disorders

• bipolar disorders

• acute substance dependency

Related Conditions & MeSH terms

• Agoraphobia

Intervention

Behavioral:
• cognitive behavioral therapy
cognitive behavioral therapy with Focus on guided exposure

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin	Berlin

Sponsors (3)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Humboldt-Universität zu Berlin, Stiftung Deutsche Klassenlotterie Berlin

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MI	Mobility Inventory	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)
Secondary	AKF	Angst-Kontroll-Fragebogen (anxiety control)	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)
Secondary	ASI	Angstsensitivität (anxiety sensitivity)	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)
Secondary	NEO-FFI	Persönlichkeitsfragebogen (personality inventory)	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)
Secondary	PSQ 20	perceived stress questionnaire	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)
Secondary	rs 13	Resilienzskala (resilience scale)	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)
Secondary	SWE	Selbstwirksamkeitsfragebogen (self-efficacy questionnaire)	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)
Secondary	UI18	Unsicherheitsintoleranz Fragebogen (intolerance of uncertainty questionnaire)	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)
Secondary	EQ-5D	life quality questionnaire	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)
Secondary	AAQ II	Acceptance and Action questionnaire	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)
Secondary	ACQ	Agoraphobic cognition questionnaire	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)
Secondary	BSQ	Bosy Sensation Questionnaire	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)
Secondary	BDI II	Beck Depression inventory 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)
Secondary	alpha-amylase	daily profile of salivary alpha amylase	change from baseline to follow up (+98 days)
Secondary	cortisol	daily profile of salivary cortisol	change from baseline to follow up (+98 days)
Secondary	PAS	Panik- und Agoraphobie-Skala (Panic and agoraphobia scale)	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)