Efficacy of Hypnotherapy for Agoraphobia

Agoraphobia Clinical Trial

— WIKI-A  

Official title:

Efficacy of Hypnotherapy Compared to a Wait-list Control Group in the Treatment of Agoraphobia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03684577
• Other study ID #: WIKI-A
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: September 29, 2020

Study information

• Verified date: November 2020
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to compare the efficacy of Hypnotherapy for the treatment of Agoraphobia compared to a wait-list control group.

Description:

With the present study, the efficacy of 8-12 sessions of individual Hypnotherapy will be compared to a wait-list control groups. At study entry and at the end of treatment with Hypnotherapy, the Agoraphobia symptoms will be assessed via clinician-rating and self-report. It is expected that Hypnotherapy will be superior to a wait-list control regarding the percentage reduction of the anxiety symptoms after three months of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 29, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Written informed consent
• Patient fulfills DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) criteria for agoraphobia
• 18 - 65 years of age
• Sufficient knowledge of the German language in order to participate in the study
• Sufficient availability to participate in weekly therapy sessions

Exclusion Criteria:

• Acute suicidality (intended action, concrete plans or intermittent pronounced suicidal ideation)
• Lifetime diagnosis of a bipolar disorder or psychotic disorder
• Alcohol or substance use disorder without abstinence in the last 12 months
• Severe cognitive impairments (in cases of suspicion evaluation via Mini Mental State Test (MMST) < 26, will be conducted)
• Other severe primary mental disorders to be treated: severe Major Depressive Disorder, severe personality disorder of borderline type with self-injury, severe combined personality disorder, actual posttraumatic stress disorder, anorexia nervosa, obsessive compulsive disorder
• Somatic disorder impeding participation in regular psychotherapy sessions
• Outpatient psychotherapy during the last twelve months.
• Medication with anxiolytics or anti-psychotics (antidepressant medication is permitted if stable since more than eight weeks and no planned changes during the duration of therapy)

Related Conditions & MeSH terms

• Agoraphobia

Intervention

Behavioral:
• Hypnotherapy for Agoraphobia
see description of the experimental arm

Locations

Country	Name	City	State
Germany	Prof. Dr. A. Batra/ Dr. Kristina Fuhr, University Department for Psychiatry and Psychotherapie	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Panic and Agoraphobia Scale (PAS)	The clinician-rating PAS will be used to measure the symptom severity (range 0-56 with higher values indicating more symptoms) for the primary outcome that is defined as the (mean) percentage change of the total symptom score between baseline (t1) and after 12 weeks (t2).	Between baseline (t1) and after 12 weeks (t2)