Efficacy of Hypnotherapy for Agoraphobia

Study Overview
=================
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.

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

Conditions
-----------------
Agoraphobia

Intervention / Treatment
-----------------
* Behavioral: Hypnotherapy for Agoraphobia


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypnotherapy for Agoraphobia<br>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<br>* see description of the experimental arm<br>|
| No Intervention: Wait-list control group<br>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) | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypnosis, Wait-list