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Clinical Trials/NCT04460378
NCT04460378UnknownNot Applicable

Exposure Initializes Therapy - Treatment Of Homebound Patients Extended

Charite University, Berlin, Germany2 sites in 1 country20 target enrollmentStarted: January 1, 2018Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
20
Locations
2
Primary Endpoint
MI
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •agoraphobia with/without Panic disorder

Exclusion Criteria

  • •psychotic disorders
  • •bipolar disorders
  • •acute substance dependency

Outcomes

Primary Outcomes

MI

Time Frame: 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 Outcomes

  • 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))
  • 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))
  • 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))
  • 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))
  • 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))
  • 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))
  • 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))
  • 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))
  • 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))
  • alpha-amylase(change from baseline to follow up (+98 days))
  • 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))
  • cortisol(change from baseline to follow up (+98 days))
  • 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))
  • 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))
  • 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))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr. Jens Plag

Dr. med. Jens Plag

Charite University, Berlin, Germany

Study Sites (2)

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Exposure Initializes Therapy - Treatment... | Clinical Trial