AgoraphobiaExITTOHoPENCT04460378
Exposure Initializes Therapy - Treatment Of Homebound Patients Extended
A study testing cognitive behavioral therapy in people with Agoraphobia, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Cognitive behavioral treatment of homebound patients with severe agoraphobia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Agoraphobia
- What is being tested?
- cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2018to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- agoraphobia with/without Panic disorder
Who cannot join
- psychotic disorders
- bipolar disorders
- acute substance dependency
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin, 10117
Jens Plag, Dr., 0049 30 450 517306, jens.plag@charite.de
Carolin Liebscher, Dr., 0049 30 450 517017, carolin.liebscher@charite.de
About this study
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.
- Conditions
- Agoraphobia
- Being tested
- cognitive behavioral therapy
- Medical subject headings
- Agoraphobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behavioral therapyBehavioural
cognitive behavioral therapy with Focus on guided exposure
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Manualized Cognitive Behavioral Therapy starting at the patients' home. Receives: Behavioral: cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
MI
Mobility Inventory
Measured: 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 (15)
AKF
Angst-Kontroll-Fragebogen (anxiety control)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: change from baseline to follow up (+98 days)
cortisol
daily profile of salivary cortisol
Measured: change from baseline to follow up (+98 days)
PAS
Panik- und Agoraphobie-Skala (Panic and agoraphobia scale)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Jan 2018
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgoraphobiaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- repeated measure of a single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Humboldt-Universität zu Berlin, Stiftung Deutsche Klassenlotterie Berlin
- Responsible party
- Principal investigator, Dr. Jens Plag, Charite University, Berlin, Germany
- Investigators
- Jens Plag, MD, Study chair, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460378
- Sponsor's protocol ID
- ChariteAmb
- Acronym
- ExITTOHoPE
- Status last verified
- Jul 2020
- First submitted
- 22 Mar 2018
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exposure Initializes Therapy - Treatment Of Homebound Patients Extended
- ClinicalTrials.gov ID
- NCT04460378
- Acronym / sponsor ID
- ExITTOHoPE / ChariteAmb
- Conditions
- Agoraphobia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Humboldt-Universität zu Berlin, Stiftung Deutsche Klassenlotterie Berlin
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- repeated measure of a single group
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Behavioral: cognitive behavioral therapyManualized Cognitive Behavioral Therapy starting at the patients' home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- agoraphobia with/without Panic disorder
Key exclusion criteria (3 listed)
- psychotic disorders
- bipolar disorders
- acute substance dependency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive behavioral therapycognitive behavioral therapy with Focus on guided exposure | Behavioural | Cognitive Behavioral Therapy |
Primary outcome
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
15 secondary outcomes
AKF
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)
ASI
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)
NEO-FFI
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)
PSQ 20
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)
rs 13
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)
SWE
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)
UI18
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)
EQ-5D
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)
AAQ 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)
ACQ
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)
BSQ
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)
BDI 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)
alpha-amylase
Time frame: change from baseline to follow up (+98 days)
cortisol
Time frame: change from baseline to follow up (+98 days)
PAS
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Plag, MD study chair
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive behavioral therapy in people with Agoraphobia, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jens Plag, Dr. (+49 30 450 510 306, jens.plag@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.