- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06022432
Overcoming Treatment Barriers (OBSTACLE-S)
Overcoming Treatment Barriers: The Role of Expectations in the Behavioral Intention of Treatment Seeking for Social Anxiety
Study Overview
Status
Intervention / Treatment
Detailed Description
The investigators expect that participants receiving an intervention e.g., amplifying positive (performance) expectancies vs. reducing negative (performance) expectancies of psychotherapeutic treatment, will show an increase in intentions to seek treatment and are more likely to report actual treatment-seeking behavior after the intervention when compared with participants who will describe their treatment expectations via a writing task.
Further, the investigators want to explore if the expectancy-modulating interventions will differently affect the intention to seek treatment within socially anxious individuals.
If participants agree, the investigators plan to assess changes in expectations, attitudes as well as actual treatment seeking behavior at a Follow-Up assessment one week later (data from Follow-Up will be analyzed exploratively and is not part of the main hypotheses).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Marburg, Germany, 35032
- Philipps-Universität Marburg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- at least 18 years old
- fluent in German (C Level)
- access to a computer device with internet access
Exclusion Criteria:
- non correctable hearing or visual impairment
- current in psychotherapeutic treatment or on a waiting list
- no neurological impairment or psychotic disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Reducing Negative Expectations
This group will watch a video of a patient-therapist interaction.
The testimonial of the patient is framed to reduce negative expectations about therapeutic treatment.
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The intervention is a prerecorded video of a re-enacted patient-therapist interaction whereby the patient gives a testimonial about the treatment process while either reducing negative expectations or maximizing positive expectations about therapy, respectively.
Other Names:
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Experimental: Maximizing Positive Expectations
This group will watch a video of a patient-therapist interaction.
The testimonial of the patient is framed to maximize positive expectations about therapeutic treatment.
|
The intervention is a prerecorded video of a re-enacted patient-therapist interaction whereby the patient gives a testimonial about the treatment process while either reducing negative expectations or maximizing positive expectations about therapy, respectively.
Other Names:
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Other: Control Group
This group will explicate their current treatment expectations in a writing task.
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Participants write freely about their current treatment expectations / apprehensions to seek treatment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Treatment Expectations (Treatment Expectation Questionnaire, "TEX-Q")
Time Frame: At baseline (pre-measurement), immediately after intervention (post-measurement, approximately 20 minutes after beginning of study procedure) and at Follow-Up investigation (one week after post measurement)
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Explicit treatment expectations measured by 15 items on a 11point Likert-scale
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At baseline (pre-measurement), immediately after intervention (post-measurement, approximately 20 minutes after beginning of study procedure) and at Follow-Up investigation (one week after post measurement)
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Changes in intention to seek treatment
Time Frame: At baseline (pre-measurement), immediately after intervention (post-measurement, approximately 20 minutes after beginning of study procedure) and at Follow-Up investigation (one week after post measurement)
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Estimated Probability to seek treatment on a self-generated rating scale from 0 (not likely at all) to 100 (very much likely)
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At baseline (pre-measurement), immediately after intervention (post-measurement, approximately 20 minutes after beginning of study procedure) and at Follow-Up investigation (one week after post measurement)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intention to seek treatment (Behavioral Outcome 1)
Time Frame: After intervention (post measurement, approximately 30 minutes after beginning of study procedure)
|
Participants respond with "yes" or "no" to indicate their interest to receive more concrete information about social anxiety and its treatment possibilities.
If the answer was answered with "yes", participants are asked to give their e-mail address to receive information which is used to assess intention to seek treatment in form of a behavioral outcome.
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After intervention (post measurement, approximately 30 minutes after beginning of study procedure)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Treatment-seeking behavior (Behavioral Outcome 2)
Time Frame: At Follow-Up investigation (one week after post measurement)
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If participants agree to participate at our Follow Up, a second behavioral outcome will be assessed.
Participants will be asked if they meanwhile have researched more concrete information about social anxiety online, connected with internet platforms or self-support groups, applied for online therapy programs/sessions, contacted or sought professional help for outpatient or psychiatric clinics.
All categories have to be answered by a dichotomous scale ("yes" or "no").
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At Follow-Up investigation (one week after post measurement)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2022-76k
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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