NCT04460378

Brief Summary

Cognitive behavioral treatment of homebound patients with severe agoraphobia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

July 7, 2020

Status Verified

July 1, 2020

Enrollment Period

2.5 years

First QC Date

March 22, 2018

Last Update Submit

July 1, 2020

Conditions

Agoraphobia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (15)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • +10 more secondary outcomes

Study Arms (1)

Cognitive Behavioral Therapy

EXPERIMENTAL

Manualized Cognitive Behavioral Therapy starting at the patients' home.

Behavioral: cognitive behavioral therapy

Interventions

cognitive behavioral therapyBEHAVIORAL

cognitive behavioral therapy with Focus on guided exposure

Cognitive Behavioral Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • agoraphobia with/without Panic disorder

You may not qualify if:

  • psychotic disorders
  • bipolar disorders
  • acute substance dependency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

RECRUITING

MeSH Terms

Conditions

Agoraphobia

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jens Plag, MD

    Charite University, Berlin, Germany

    STUDY CHAIR

Central Study Contacts

Jens Plag, Dr.

CONTACT

+49 30 450 510 306jens.plag@charite.de

Carolin Liebscher, Dr.

CONTACT

+49 30 450 517 017carolin.liebscher@charite.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: repeated measure of a single group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. Jens Plag

Study Record Dates

First Submitted

March 22, 2018

First Posted

July 7, 2020

Study Start

January 1, 2018

Primary Completion

July 1, 2020

Study Completion

October 1, 2020

Last Updated

July 7, 2020

Record last verified: 2020-07

Locations

DE(1)