search
Back to results

The Role of Treatment Expectation in Exposure Training With Spider Fearful Participants

Primary Purpose

Phobic Disorders

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
positive treatment expectations
neutral treatment expectations
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Phobic Disorders focused on measuring psychotherapy, exposition, spider fear, expectation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • acute or chronic psychiatric disorder
  • currently in psychological or psychiatric treatment
  • knowledge of exposure training

Sites / Locations

  • Department of Clinical Psychology and Psychotherapy University of Basel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

experimental group

comparator group

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Change in subjective anxiety assessed by questionnaire
assessment of change in subjective anxiety by questionnaire at selcted time points

Secondary Outcome Measures

Full Information

First Posted
December 21, 2016
Last Updated
March 20, 2018
Sponsor
University Hospital, Basel, Switzerland
search

1. Study Identification

Unique Protocol Identification Number
NCT03012035
Brief Title
The Role of Treatment Expectation in Exposure Training With Spider Fearful Participants
Official Title
The Role of Treatment Expectation in Exposure Training With Spider Fearful Participants
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
May 18, 2017 (Actual)
Primary Completion Date
March 12, 2018 (Actual)
Study Completion Date
March 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phobic Disorders
Keywords
psychotherapy, exposition, spider fear, expectation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
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).
Arm Title
comparator group
Arm Type
Other
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
positive treatment expectations
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
neutral treatment expectations
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in subjective anxiety assessed by questionnaire
Description
assessment of change in subjective anxiety by questionnaire at selcted time points
Time Frame
Baseline, Pre exposition, Post exposition, Recovery; time between baseline and recovery approximately lasts 21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: acute or chronic psychiatric disorder currently in psychological or psychiatric treatment knowledge of exposure training
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Gaab, Prof. Dr.
Organizational Affiliation
Department of Clinical Psychology and Psychotherapy University of Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Psychology and Psychotherapy University of Basel
City
Basel
ZIP/Postal Code
4055
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Role of Treatment Expectation in Exposure Training With Spider Fearful Participants

We'll reach out to this number within 24 hrs