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Efficacy of Hypnotherapy for Agoraphobia (WIKI-A)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03684577
Recruitment Status : Completed
First Posted : September 25, 2018
Last Update Posted : November 5, 2020
Sponsor:
Information provided by (Responsible Party):
Anil Batra, University Hospital Tuebingen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Agoraphobia Behavioral: Hypnotherapy for Agoraphobia Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Hypnotherapy Compared to a Wait-list Control Group in the Treatment of Agoraphobia
Actual Study Start Date : November 1, 2018
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : September 29, 2020
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03684577


Locations
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Germany
Prof. Dr. A. Batra/ Dr. Kristina Fuhr, University Department for Psychiatry and Psychotherapie
Tuebingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
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Principal Investigator: Anil Batra, Prof. University Hospital Tuebingen
More Information
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Responsible Party: Anil Batra, Prof. Dr. Anil Batra, Pricinpal Investigator, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT03684577    
Other Study ID Numbers: WIKI-A
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anil Batra, University Hospital Tuebingen:
Hypnosis
Wait-list
Additional relevant MeSH terms:
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Agoraphobia
Phobic Disorders
Anxiety Disorders
Mental Disorders