Efficacy of Hypnotherapy for Agoraphobia (WIKI-A)

November 3, 2020 updated by: Anil Batra, University Hospital Tuebingen

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tuebingen, Germany, 72076
        • Prof. Dr. A. Batra/ Dr. Kristina Fuhr, University Department for Psychiatry and Psychotherapie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Hypnotherapy for Agoraphobia
A total of 8-12 individual sessions of hypnotherapy over 12 weeks will be delivered. Hypnotherapy consists of hypnotic activation and reinforcement of the patient's own resources, the use of relevant positive and negative experiences from the biography, and the development of positive solution imagery. The central technique is the work with a symptom regression and the resolution of old and actual experiences. Furthermore, formal trance induction, utilisation techniques, indirect techniques such as the use of metaphors or the representative technique, or work with time progression will be used.
Behavioral: Hypnotherapy for Agoraphobia
see description of the experimental arm
NO_INTERVENTION: Wait-list control group
Patients in the wait-list control group will receive 8-12 sessions of individual hypnotherapy after a waiting period for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Panic and Agoraphobia Scale (PAS)
Time Frame: 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).
Between baseline (t1) and after 12 weeks (t2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2018

Primary Completion (ACTUAL)

June 30, 2020

Study Completion (ACTUAL)

September 29, 2020

Study Registration Dates

First Submitted

September 21, 2018

First Submitted That Met QC Criteria

September 24, 2018

First Posted (ACTUAL)

September 25, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 5, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WIKI-A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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