NCT03684577

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2020

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

1.7 years

First QC Date

September 21, 2018

Last Update Submit

November 3, 2020

Conditions

Agoraphobia

Keywords

HypnosisWait-list

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (2)

Hypnotherapy for Agoraphobia

EXPERIMENTAL

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

Wait-list control group

NO INTERVENTION

Patients in the wait-list control group will receive 8-12 sessions of individual hypnotherapy after a waiting period for 12 weeks.

Interventions

Hypnotherapy for AgoraphobiaBEHAVIORAL

see description of the experimental arm

Hypnotherapy for Agoraphobia

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent
  • Patient fulfills DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) criteria for agoraphobia
  • years of age
  • Sufficient knowledge of the German language in order to participate in the study
  • Sufficient availability to participate in weekly therapy sessions

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Dr. A. Batra/ Dr. Kristina Fuhr, University Department for Psychiatry and Psychotherapie

Tübingen, 72076, Germany

Location

Related Publications (1)

  • Fuhr K, Bender A, Wiegand A, Janouch P, Drujan M, Cyrny B, Schweizer C, Kreifelts B, Nieratschker V, Batra A. Hypnotherapy for agoraphobia-Feasibility and efficacy investigated in a pilot study. Front Psychol. 2023 Aug 10;14:1213792. doi: 10.3389/fpsyg.2023.1213792. eCollection 2023.

    PMID: 37637902DERIVED

MeSH Terms

Conditions

Agoraphobia

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Anil Batra, Prof.

    University Hospital Tuebingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Anil Batra, Pricinpal Investigator

Study Record Dates

First Submitted

September 21, 2018

First Posted

September 25, 2018

Study Start

November 1, 2018

Primary Completion

June 30, 2020

Study Completion

September 29, 2020

Last Updated

November 5, 2020

Record last verified: 2020-11

Locations

DE(1)