Phobic DisordersNCT03012035
The Role of Treatment Expectation in Exposure Training With Spider Fearful Participants
A study testing positive treatment expectations and neutral treatment expectations in people with Phobic Disorders, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This study evaluates the role of treatment success expectation in spider fearful individuals on the actual treatment success. Half of participants will have positive treatment success expectations, while the other half will have neutral treatment outcome expectations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Phobic Disorders
- What is being tested?
- positive treatment expectations and neutral treatment expectations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSwitzerland
- Study dates
- 18 May 2017to 12 Mar 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- good knowledge of German language
- fulfilling criteria A-E and G for specific phobia according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-V (fulfilling criteria F is not an inclusion criteria)
- marked fear or anxiety about spiders
- spiders almost always provoke immediate fear or anxiety
- spiders are actively avoided or endured with intense fear or anxiety
- the fear or anxiety is out of proportion to the actual danger posed by spiders
- the fear, anxiety, or avoidance is persistent, typically lasting for 6 months or more
- the disturbance is not better explained by the symptoms of mental disorders as agoraphobia, obsessive-compulsive disorder, posttraumatic stress disorder, separation anxiety or social anxiety disorder
Who cannot join
- acute or chronic psychiatric disorder
- currently in psychological or psychiatric treatment
- knowledge of exposure training
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Clinical Psychology and Psychotherapy University of Basel
Basel, 4055
About this study
This study evaluates the role of treatment success expectation in spider fearful individuals on the actual treatment success. Half of participants will have positive treatment success expectations, while the other half will have neutral treatment outcome expectations.
Read the detailed description
The investigator plan to conduct a randomized, single blind study with two parallel groups. Both groups undergo the same standardized psychotherapeutic intervention, i.e. exposure training. All participants will receive the same exposure training in groups of maximum three participants of the same study group. The two study groups only differ regarding the induced treatment expectations towards the effects of the exposure training. While the experimental group will get an open administration of treatment and be informed in order to have a positive treatment expectation, the comparator group will receive a hidden administration of treatment and get neutral information, thus treatment expectations will be neutral. Study members conducting the exposure training with the participants will not be aware of the allocation of the study participants. Study participants will be informed about the aim of the allocated condition, but they will be blind to the aim of the study in order to induce the specific expectation. Differences in treatment outcomes are compared between both groups to investigate the association with treatment expectation.
- Conditions
- Phobic Disorders
- Being tested
- positive treatment expectations, neutral treatment expectations
- Keywords
- psychotherapy, exposition, spider fear, expectation
- Medical subject headings
- Phobic Disorders, Arachnophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
positive treatment expectationsOther
Before participants undergo the exposure training their expectation of treatment efficacy is manipulated with different information regarding the following treatment. The experimental group will get positive treatment expectations induced with the accurate information, that exposure training refers to the gold standard in psychotherapy to reduce spider fear (= open administration of treatment).
neutral treatment expectationsOther
The comparator group will get neutral expectations regarding treatment outcome. To induce neutral treatment expectations about the following exposure training, it is necessary to tell them they are in the comparator group and that they will receive a comparator condition exposure training for diagnostic purposes only (= hidden administration of treatment).
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Before participants undergo the exposure training their expectation of treatment efficacy is manipulated with different information regarding the following treatment. The experimental group will get positive treatment expectations induced with the accurate information, that exposure training refers to the gold standard in psychotherapy to reduce spider fear (= open administration of treatment). Receives: Other: positive treatment expectations |
| comparator group | Other | The comparator group will get neutral expectations regarding treatment outcome. To induce neutral treatment expectations about the following exposure training, it is necessary to tell them they are in the comparator group and that they will receive a comparator condition exposure training for diagnostic purposes only (= hidden administration of treatment). Receives: Other: neutral treatment expectations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in subjective anxiety assessed by questionnaire
assessment of change in subjective anxiety by questionnaire at selcted time points
Measured: Baseline, Pre exposition, Post exposition, Recovery; time between baseline and recovery approximately lasts 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study start18 May 2017
- Primary completion12 Mar 2018
- Study completion12 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phobic DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jens Gaab, Prof. Dr., Principal investigator, Department of Clinical Psychology and Psychotherapy University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012035
- Sponsor's protocol ID
- SPFE 2017
- Status last verified
- Mar 2018
- First submitted
- 21 Dec 2016
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Treatment Expectation in Exposure Training With Spider Fearful Participants
- ClinicalTrials.gov ID
- NCT03012035
- Acronym / sponsor ID
- SPFE 2017
- Conditions
- Phobic Disorders
- Keywords
- psychotherapy, exposition, spider fear, expectation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 18 May 2017 (actual)
- Primary completion
- 12 Mar 2018 (actual)
- Study completion
- 12 Mar 2018 (actual)
- First posted
- 6 Jan 2017 (estimated)
- 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.
This study evaluates the role of treatment success expectation in spider fearful individuals on the actual treatment success. Half of participants will have positive treatment success expectations, while the other half will have neutral treatment outcome expectations.
Detailed description
The investigator plan to conduct a randomized, single blind study with two parallel groups. Both groups undergo the same standardized psychotherapeutic intervention, i.e. exposure training. All participants will receive the same exposure training in groups of maximum three participants of the same study group. The two study groups only differ regarding the induced treatment expectations towards the effects of the exposure training. While the experimental group will get an open administration of treatment and be informed in order to have a positive treatment expectation, the comparator group will receive a hidden administration of treatment and get neutral information, thus treatment expectations will be neutral. Study members conducting the exposure training with the participants will not be aware of the allocation of the study participants. Study participants will be informed about the aim of the allocated condition, but they will be blind to the aim of the study in order to induce the specific expectation. Differences in treatment outcomes are compared between both groups to investigate the association with treatment expectation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: positive treatment expectationsBefore participants undergo the exposure training their expectation of treatment efficacy is manipulated with different information regarding the following treatment. The experimental group will get positive treatment expectations induced with the accurate information, that exposure training refers to the gold standard in psychotherapy to reduce spider fear (= open administration of treatment). |
| comparator group | Other | Other: neutral treatment expectationsThe comparator group will get neutral expectations regarding treatment outcome. To induce neutral treatment expectations about the following exposure training, it is necessary to tell them they are in the comparator group and that they will receive a comparator condition exposure training for diagnostic purposes only (= hidden administration of treatment). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- good knowledge of German language
- fulfilling criteria A-E and G for specific phobia according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-V (fulfilling criteria F is not an inclusion criteria)
Key exclusion criteria (3 listed)
- acute or chronic psychiatric disorder
- currently in psychological or psychiatric treatment
- knowledge of exposure training
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 |
|---|---|---|
| positive treatment expectationsBefore participants undergo the exposure training their expectation of treatment efficacy is manipulated with different information regarding the following treatment. The experimental group will get positive treatment expectations induced with the accurate information, that exposure training refers to the gold standard in psychotherapy to reduce spider fear (= open administration of treatment). | Other | experimental group |
| neutral treatment expectationsThe comparator group will get neutral expectations regarding treatment outcome. To induce neutral treatment expectations about the following exposure training, it is necessary to tell them they are in the comparator group and that they will receive a comparator condition exposure training for diagnostic purposes only (= hidden administration of treatment). | Other | comparator group |
Primary outcome
Change in subjective anxiety assessed by questionnaire
Time frame: Baseline, Pre exposition, Post exposition, Recovery; time between baseline and recovery approximately lasts 21 days
assessment of change in subjective anxiety by questionnaire at selcted time points
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 21 Mar 2018.
- Individual participant dataSharing planned: No
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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.
Jens Gaab, Prof. Dr. principal investigator
Department of Clinical Psychology and Psychotherapy University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing positive treatment expectations and neutral treatment expectations in people with Phobic Disorders, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 8 inclusion and 3 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 21 Mar 2018. 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 Switzerland. 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?
Change in subjective anxiety assessed by questionnaire (time frame: Baseline, Pre exposition, Post exposition, Recovery; time between baseline and recovery approximately lasts 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Mar 2018.