Exposure Initializes Therapy - Treatment Of Homebound Patients Extended (ExITTOHoPE)

Cognitive behavioral treatment of homebound patients with severe agoraphobia.

Study Overview

• Status: Unknown
• Conditions: Agoraphobia
• Intervention / Treatment: Behavioral: cognitive behavioral therapy

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jens Plag, Dr.; Phone Number: +49 30 450 510 306; Email: jens.plag@charite.de
• Study Contact Backup: Name: Carolin Liebscher, Dr.; Phone Number: +49 30 450 517 017; Email: carolin.liebscher@charite.de

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Recruiting
    • Charité - Universitätsmedizin Berlin
    • Contact: Jens Plag, Dr.; Phone Number: 0049 30 450 517306; Email: jens.plag@charite.de
    • Contact: Carolin Liebscher, Dr.; Phone Number: 0049 30 450 517017; Email: carolin.liebscher@charite.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• agoraphobia with/without Panic disorder

Exclusion Criteria:

• psychotic disorders
• bipolar disorders
• acute substance dependency

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Behavioral Therapy; Manualized Cognitive Behavioral Therapy starting at the patients' home.	Behavioral: cognitive behavioral therapy; cognitive behavioral therapy with Focus on guided exposure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
alpha-amylase	daily profile of salivary alpha amylase	change from baseline to follow up (+98 days)
cortisol	daily profile of salivary cortisol	change from baseline to follow up (+98 days)
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)

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: Humboldt-Universität zu Berlin; Stiftung Deutsche Klassenlotterie Berlin
• Investigators: Study Chair: Jens Plag, MD, Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: March 22, 2018
• First Submitted That Met QC Criteria: July 1, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 1, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Agoraphobia
• Other Study ID Numbers: ChariteAmb

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No