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Status unknownNCT04460378ExITTOHoPEUpdated Jul 7, 2020

Exposure Initializes Therapy - Treatment Of Homebound Patients Extended

An interventional study of cognitive behavioral therapy in Agoraphobia, sponsored by Charite University, Berlin, Germany. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-07.

Sponsored by Charite University, Berlin, Germany · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Cognitive behavioral treatment of homebound patients with severe agoraphobia.

Read the 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.

02

Conditions studied

  • Agoraphobia

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03

In context

Agoraphobia

65 studies on the registry are indexed under Agoraphobia; 12 are open to participants now.

This study's planned enrollment of 20 is below the median of 78 across 61 interventional studies indexed under Agoraphobia.

Browse Agoraphobia studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 857 studies on the registry; 129 are open to participants now.

Browse Charite University, Berlin, Germany studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • agoraphobia with/without Panic disorder

Exclusion criteria

Exclusion Criteria:

  • psychotic disorders
  • bipolar disorders
  • acute substance dependency
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Cognitive Behavioral Therapy

    Manualized Cognitive Behavioral Therapy starting at the patients' home.

    Behavioral: cognitive behavioral therapy

Interventions

  • Behavioralcognitive behavioral therapy

    cognitive behavioral therapy with Focus on guided exposure

06

What researchers measure

Primary outcomes

  1. MI

    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 outcomes

  1. AKF

    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)

  2. ASI

    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)

  3. NEO-FFI

    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)

  4. PSQ 20

    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)

  5. rs 13

    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)

  6. SWE

    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)

  7. UI18

    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)

  8. EQ-5D

    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)

  9. AAQ II

    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)

  10. ACQ

    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)

  11. BSQ

    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)

  12. BDI II

    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)

  13. alpha-amylase

    daily profile of salivary alpha amylase

    Time frame: change from baseline to follow up (+98 days)

  14. cortisol

    daily profile of salivary cortisol

    Time frame: change from baseline to follow up (+98 days)

  15. PAS

    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)

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2018 (actual). Primary completion is estimated for Jul 2020, 30 months after the start.

Of 35 non-industry interventional studies with no phase under Agoraphobia, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 53. This study's planned 30 months is below that.

Counting every sponsor, half of 35 studies reached it within 44 months; a quarter within 19 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 22, 2018
First posted
Jul 7, 2020
StartActual
Jan 1, 2018
Primary completionEst.
Jul 1, 2020
CompletionEst.
Oct 1, 2020
Last update
Jul 7, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04460378
Lead sponsor
Charite University, Berlin, Germany
Collaborators
Humboldt-Universität zu Berlin, Stiftung Deutsche Klassenlotterie Berlin
Responsible party
Dr. Jens Plag (Dr. med. Jens Plag, Charite University, Berlin, Germany) — Principal investigator
First posted
Jul 7, 2020
Start date
Jan 1, 2018
Primary completion
Jul 1, 2020 (estimated)
Completion
Oct 1, 2020 (estimated)
Last update
Jul 7, 2020

Study contacts

Jens Plag, Dr.
Contact
jens.plag@charite.de
+49 30 450 510 306
Carolin Liebscher, Dr.
Contact
carolin.liebscher@charite.de
+49 30 450 517 017
Jens Plag, MD
study chair · Charite University, Berlin, Germany

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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