Clinical trial NCT04460378: Exposure Initializes Therapy - Treatment Of Homebound Patients Extended
Official title: Exposure Initializes Therapy - Treatment Of Homebound Patients Extended
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Agoraphobia
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Humboldt-Universität zu Berlin
name: Stiftung Deutsche Klassenlotterie Berlin
First posted: 2020-07-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: repeated measure of a single group
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* agoraphobia with/without Panic disorder

Exclusion Criteria:

* psychotic disorders
* bipolar disorders
* acute substance dependency

Primary outcomes:
measure: MI
timeFrame: 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 outcomes:
measure: AKF
timeFrame: 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)
measure: ASI
timeFrame: 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)
measure: NEO-FFI
timeFrame: 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)
measure: PSQ 20
timeFrame: 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)
measure: rs 13
timeFrame: 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)
measure: SWE
timeFrame: 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)
measure: UI18
timeFrame: 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)
measure: EQ-5D
timeFrame: 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)
measure: AAQ II
timeFrame: 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)
measure: ACQ
timeFrame: 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)
measure: BSQ
timeFrame: 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)
measure: BDI II
timeFrame: 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)
measure: alpha-amylase
timeFrame: change from baseline to follow up (+98 days)
measure: cortisol
timeFrame: change from baseline to follow up (+98 days)
measure: PAS
timeFrame: 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)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Jens Plag, MD
role: STUDY_CHAIR
References: