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Completed

NCT Number: NCT03012035

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical Psychology and Psychotherapy University of Basel

Basel, 4055, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

positive treatment expectations

Other

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 expectations

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).

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 6, 2017
Registry last updated
Mar 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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