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

Primary Purpose

Agoraphobia

Status

Unknown status

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

cognitive behavioral therapy

About this trial

This is an interventional treatment trial for Agoraphobia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

agoraphobia with/without Panic disorder

Exclusion Criteria:

psychotic disorders
bipolar disorders
acute substance dependency

Sites / Locations

Charité - Universitätsmedizin BerlinRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cognitive Behavioral Therapy

Arm Description

Manualized Cognitive Behavioral Therapy starting at the patients' home.

Outcomes

Primary Outcome Measures

Mobility Inventory

Secondary Outcome Measures

AKF

Angst-Kontroll-Fragebogen (anxiety control)

ASI

Angstsensitivität (anxiety sensitivity)

NEO-FFI

Persönlichkeitsfragebogen (personality inventory)

PSQ 20

perceived stress questionnaire

rs 13

Resilienzskala (resilience scale)

SWE

Selbstwirksamkeitsfragebogen (self-efficacy questionnaire)

UI18

Unsicherheitsintoleranz Fragebogen (intolerance of uncertainty questionnaire)

EQ-5D

life quality questionnaire

AAQ II

Acceptance and Action questionnaire

ACQ

Agoraphobic cognition questionnaire

BSQ

Bosy Sensation Questionnaire

BDI II

Beck Depression inventory II

alpha-amylase

daily profile of salivary alpha amylase

cortisol

daily profile of salivary cortisol

PAS

Panik- und Agoraphobie-Skala (Panic and agoraphobia scale)

Full Information

NCT ID

NCT04460378

First Posted

March 22, 2018

Last Updated

July 1, 2020

Sponsor

Charite University, Berlin, Germany

Collaborators

Humboldt-Universität zu Berlin, Stiftung Deutsche Klassenlotterie Berlin

1. Study Identification

Unique Protocol Identification Number

NCT04460378

Brief Title

Exposure Initializes Therapy - Treatment Of Homebound Patients Extended

Acronym

ExITTOHoPE

Official Title

Exposure Initializes Therapy - Treatment Of Homebound Patients Extended

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2018 (Actual)

Primary Completion Date

July 1, 2020 (Anticipated)

Study Completion Date

October 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Charite University, Berlin, Germany

Collaborators

Humboldt-Universität zu Berlin, Stiftung Deutsche Klassenlotterie Berlin

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Agoraphobia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

repeated measure of a single group

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cognitive Behavioral Therapy

Arm Type

Experimental

Arm Description

Manualized Cognitive Behavioral Therapy starting at the patients' home.

Intervention Type

Behavioral

Intervention Name(s)

cognitive behavioral therapy

Intervention Description

cognitive behavioral therapy with Focus on guided exposure

Primary Outcome Measure Information:

Title

Description

Mobility Inventory

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)

Secondary Outcome Measure Information:

Title

AKF

Description

Angst-Kontroll-Fragebogen (anxiety control)

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)

Title

ASI

Description

Angstsensitivität (anxiety sensitivity)

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)

Title

NEO-FFI

Description

Persönlichkeitsfragebogen (personality inventory)

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)

Title

PSQ 20

Description

perceived stress questionnaire

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)

Title

rs 13

Description

Resilienzskala (resilience scale)

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)

Title

SWE

Description

Selbstwirksamkeitsfragebogen (self-efficacy questionnaire)

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)

Title

UI18

Description

Unsicherheitsintoleranz Fragebogen (intolerance of uncertainty questionnaire)

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)

Title

EQ-5D

Description

life quality questionnaire

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)

Title

AAQ II

Description

Acceptance and Action questionnaire

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)

Title

ACQ

Description

Agoraphobic cognition questionnaire

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)

Title

BSQ

Description

Bosy Sensation Questionnaire

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)

Title

BDI II

Description

Beck Depression inventory II

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)

Title

alpha-amylase

Description

daily profile of salivary alpha amylase

Time Frame

change from baseline to follow up (+98 days)

Title

cortisol

Description

daily profile of salivary cortisol

Time Frame

change from baseline to follow up (+98 days)

Title

PAS

Description

Panik- und Agoraphobie-Skala (Panic and agoraphobia scale)

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: agoraphobia with/without Panic disorder Exclusion Criteria: psychotic disorders bipolar disorders acute substance dependency

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jens Plag, Dr.

Phone

+49 30 450 510 306

jens.plag@charite.de

First Name & Middle Initial & Last Name or Official Title & Degree

Carolin Liebscher, Dr.

Phone

+49 30 450 517 017

carolin.liebscher@charite.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jens Plag, MD

Organizational Affiliation

Charite University, Berlin, Germany

Official's Role

Study Chair

Facility Information:

Facility Name

Charité - Universitätsmedizin Berlin

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jens Plag, Dr.

Phone

0049 30 450 517306

jens.plag@charite.de

First Name & Middle Initial & Last Name & Degree

Carolin Liebscher, Dr.

Phone

0049 30 450 517017

carolin.liebscher@charite.de

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Exposure Initializes Therapy - Treatment Of Homebound Patients Extended

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