Efficacy of Hypnotherapy for Agoraphobia

Not Applicable

Completed

• Conditions: Agoraphobia

• Registration Number: NCT03684577
• Lead Sponsor: University Hospital Tuebingen

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-09-21
• Study First Submitted QC: 2018-09-24
• Study First Posted: 2018-09-25
• Study Start: 2018-11-01
• Primary Completion: 2020-06-30
• Study Completion: 2020-09-29
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Panic and Agoraphobia Scale (PAS)	Between baseline (t1) and after 12 weeks (t2)	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).

Trial Locations

Locations (1)

Prof. Dr. A. Batra/ Dr. Kristina Fuhr, University Department for Psychiatry and Psychotherapie; 🇩🇪 Tuebingen, Germany