Back to resultsEfficacy of Hypnotherapy for Agoraphobia (WIKI-A)
Primary Purpose
Agoraphobia
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Hypnotherapy for Agoraphobia
Sponsored by
About this trial
This is an interventional treatment trial for Agoraphobia focused on measuring Hypnosis, Wait-list
Eligibility 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)
Sites / Locations
- Prof. Dr. A. Batra/ Dr. Kristina Fuhr, University Department for Psychiatry and Psychotherapie
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Hypnotherapy for Agoraphobia
Wait-list control group
Arm Description
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.
Patients in the wait-list control group will receive 8-12 sessions of individual hypnotherapy after a waiting period for 12 weeks.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT03684577
First Posted
September 21, 2018
Last Updated
November 3, 2020
Sponsor
University Hospital Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT03684577
Brief Title
Efficacy of Hypnotherapy for Agoraphobia
Acronym
WIKI-A
Official Title
Efficacy of Hypnotherapy Compared to a Wait-list Control Group in the Treatment of Agoraphobia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
September 29, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Tuebingen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agoraphobia
Keywords
Hypnosis, Wait-list
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hypnotherapy for Agoraphobia
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait-list control group
Arm Type
No Intervention
Arm Description
Patients in the wait-list control group will receive 8-12 sessions of individual hypnotherapy after a waiting period for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Hypnotherapy for Agoraphobia
Intervention Description
see description of the experimental arm
Primary Outcome Measure Information:
Title
Panic and Agoraphobia Scale (PAS)
Description
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).
Time Frame
Between baseline (t1) and after 12 weeks (t2)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anil Batra, Prof.
Organizational Affiliation
University Hospital Tuebingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prof. Dr. A. Batra/ Dr. Kristina Fuhr, University Department for Psychiatry and Psychotherapie
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Hypnotherapy for Agoraphobia
We'll reach out to this number within 24 hrs