AgoraphobiaWIKI-ANCT03684577
Efficacy of Hypnotherapy for Agoraphobia
A study testing Hypnotherapy for Agoraphobia in people with Agoraphobia, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Agoraphobia
- What is being tested?
- Hypnotherapy for Agoraphobia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2018to 29 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Prof. Dr. A. Batra/ Dr. Kristina Fuhr, University Department for Psychiatry and Psychotherapie
Tübingen, 72076
About this study
Official title: 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.
Read the 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.
- Conditions
- Agoraphobia
- Being tested
- Hypnotherapy for Agoraphobia
- Keywords
- Hypnosis, Wait-list
- Medical subject headings
- Agoraphobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypnotherapy for AgoraphobiaBehavioural
see description of the experimental arm
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Between baseline (t1) and after 12 weeks (t2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start1 Nov 2018
- Primary completion30 Jun 2020
- Study completion29 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgoraphobiaStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anil Batra, University Hospital Tuebingen
- Investigators
- Anil Batra, Prof., Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03684577
- Sponsor's protocol ID
- WIKI-A
- Acronym
- WIKI-A
- Status last verified
- Nov 2020
- First submitted
- 21 Sep 2018
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37637902
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Hypnotherapy Compared to a Wait-list Control Group in the Treatment of Agoraphobia
- ClinicalTrials.gov ID
- NCT03684577
- Acronym / sponsor ID
- WIKI-A / WIKI-A
- Conditions
- Agoraphobia
- Keywords
- Hypnosis, Wait-list
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 29 Sep 2020 (actual)
- First posted
- 25 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypnotherapy for Agoraphobia | Experimental | Behavioral: Hypnotherapy for AgoraphobiaA 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypnotherapy for Agoraphobiasee description of the experimental arm | Behavioural | Hypnotherapy for Agoraphobia |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Derived from this study: PubMed 37637902Fuhr 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anil Batra, Prof. principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnotherapy for Agoraphobia in people with Agoraphobia, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Panic and Agoraphobia Scale (PAS) (time frame: Between baseline (t1) and after 12 weeks (t2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03684577, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.