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Effects of Stress on Exposure Therapy

Primary Purpose

Specific Phobia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Cold water condition
Warm water condition
Sponsored by
Ruhr University of Bochum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Specific Phobia focused on measuring anxiety disorders, spider phobia, stress, exposure therapy, generalization

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women using oral contraceptives (OC)
  • Specific phobia (spider phobia)

Exclusion Criteria:

  • Body Mass Index (BMI) < 19 or > 27
  • Pregnancy
  • Any acute or chronic mental, somatic, endocrine, or metabolic disease
  • Psychological, psychiatric, neurological or pharmacological treatment
  • Shift work
  • Smoking more than 5 cigarettes per month
  • Vaccination in the past 2 month
  • Drug or alcohol abuse

Sites / Locations

  • Mental Health Research and Treatment Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stress + Exposure

Control + Exposure

Arm Description

Stress Condition: Cold water condition of the socially evaluated cold pressor test (SECPT; Schwabe et al, 2008).

Control condition: Warm water condition of the SECPT.

Outcomes

Primary Outcome Measures

Change in the Behavioral Approach Test (BAT) with spiders (treated fear stimulus)
During the Behavioral Approach Test (BAT) the closest distance to a spider as well as subjective fear and heart rate is measured.
Change in the Behavioral Approach Test with Cockroaches (untreated fear stimulus)
During the Behavioral Approach Test (BAT) the closest distance to a cockroach as well as subjective fear and heart rate is measured.

Secondary Outcome Measures

Change in the Spider-fear Related questionnaires
Self-report questionnaires assessing fear of spiders will be used. The Fear of Spiders Questionnaire (FSQ) and the Spider Beliefs Questionnaire (SBQ) will be employed. Scores on these scales range from 0 to 108 and 0 to 100, respectively, with higher scores indicating greater fear of spiders.
Change in the Cockroach-fear related questionnaires
Self-report questionnaires assessing fear of cockroaches will be used. The Fear of Cockroach Questionnaire and the Cockroach Beliefs Questionnaire will be employed. Scores on these scales range from 0 to 108 and 0 to 100, respectively, with higher scores indicating greater fear of cockroaches.
Free cortisol concentrations
Manipulation check (SECPT). Saliva will be collected using salivette sampling devices (Sarstedt, Nümbrecht) at different time points to assess free cortisol concentrations and activity of the enzyme alpha amylase
Blood pressure
Manipulation check (SECPT). Systolic and diastolic blood pressure (mm/Hg) are measured at different time points
Activity of the enzyme alpha amylase
Alpha amylase will be collected using salivette sampling devices

Full Information

First Posted
February 1, 2018
Last Updated
September 10, 2019
Sponsor
Ruhr University of Bochum
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1. Study Identification

Unique Protocol Identification Number
NCT03505437
Brief Title
Effects of Stress on Exposure Therapy
Official Title
The Impact of Stress on Exposure-based Treatment Outcome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
April 20, 2018 (Actual)
Primary Completion Date
May 30, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruhr University of Bochum

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study investigates whether stress can augment exposure therapy outcome in patients with specific phobia (spider phobia).
Detailed Description
Stress has been shown to modulate fear extinction. The present study is aimed at investigating whether stress (administered prior to exposure with the socially evaluated cold pressor test) augments exposure therapy outcome in patients with specific phobia (spider phobia). Furthermore, the effects of stress on the generalization of exposure-induced symptom reduction towards untreated fear stimuli (i.e. cockroaches) will be explored. Participants are randomly assigned to the cold or warm water condition of the socially evaluated cold pressor test (SECPT; Schwabe et al., 2008). Thereafter, participants of both conditions receive 45 minutes of in-vivo exposure to spiders. The effects of stress on exposure-based anxiety reductions toward spiders (treated fear stimulus) and cockroaches (untreated fear stimulus to assess generalization of treatment outcome) are assessed on the behavioral, subjective and physiological level at pretreatment, posttreatment (24 hours after exposure) and follow-up (4 weeks after exposure).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Specific Phobia
Keywords
anxiety disorders, spider phobia, stress, exposure therapy, generalization

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stress + Exposure
Arm Type
Experimental
Arm Description
Stress Condition: Cold water condition of the socially evaluated cold pressor test (SECPT; Schwabe et al, 2008).
Arm Title
Control + Exposure
Arm Type
Active Comparator
Arm Description
Control condition: Warm water condition of the SECPT.
Intervention Type
Other
Intervention Name(s)
Cold water condition
Intervention Description
Cold water condition of the SECPT. Participants immerse their hand into ice-cold water (0-3°C). During the SECPT, participants are videotyped and monitored. After the SECPT, participants will receive 45 minutes of in-vivo exposure to spiders
Intervention Type
Other
Intervention Name(s)
Warm water condition
Intervention Description
Warm water condition of the SECPT. Participants immerse their hand into warm water (36-37°C). Participants are neither videotyped nor monitored during the whole procedure. After the SECPT, participants will receive 45 minutes of in-vivo exposure to spiders.
Primary Outcome Measure Information:
Title
Change in the Behavioral Approach Test (BAT) with spiders (treated fear stimulus)
Description
During the Behavioral Approach Test (BAT) the closest distance to a spider as well as subjective fear and heart rate is measured.
Time Frame
Pretreatment, Posttreatment, Follow-up (with approx. 1 day between pre- and posttreatment and 4 weeks between pretreatment and follow-up)
Title
Change in the Behavioral Approach Test with Cockroaches (untreated fear stimulus)
Description
During the Behavioral Approach Test (BAT) the closest distance to a cockroach as well as subjective fear and heart rate is measured.
Time Frame
Pretreatment, Follow-up (with approx. 4 weeks between pretreatment and follow-up)
Secondary Outcome Measure Information:
Title
Change in the Spider-fear Related questionnaires
Description
Self-report questionnaires assessing fear of spiders will be used. The Fear of Spiders Questionnaire (FSQ) and the Spider Beliefs Questionnaire (SBQ) will be employed. Scores on these scales range from 0 to 108 and 0 to 100, respectively, with higher scores indicating greater fear of spiders.
Time Frame
Pretreatment, Posttreatment, Follow-up (with approx. 1 day between pre- and posttreatment and 4 weeks between pretreatment and follow-up)
Title
Change in the Cockroach-fear related questionnaires
Description
Self-report questionnaires assessing fear of cockroaches will be used. The Fear of Cockroach Questionnaire and the Cockroach Beliefs Questionnaire will be employed. Scores on these scales range from 0 to 108 and 0 to 100, respectively, with higher scores indicating greater fear of cockroaches.
Time Frame
Pretreatment, Posttreatment, Follow-up (with approx. 1 day between pre- and posttreatment and 4 weeks between pretreatment and follow-up)
Title
Free cortisol concentrations
Description
Manipulation check (SECPT). Saliva will be collected using salivette sampling devices (Sarstedt, Nümbrecht) at different time points to assess free cortisol concentrations and activity of the enzyme alpha amylase
Time Frame
5 times at Pretreatment, 2 times at Posttreatment, 2 times at Follow-up. (with approx. 1 day between pre- and posttreatment and 4 weeks between pretreatment and follow-up)
Title
Blood pressure
Description
Manipulation check (SECPT). Systolic and diastolic blood pressure (mm/Hg) are measured at different time points
Time Frame
9 times at Pretreatment
Title
Activity of the enzyme alpha amylase
Description
Alpha amylase will be collected using salivette sampling devices
Time Frame
5 times at Pretreatment, 2 times at Posttreatment, 2 times at Follow-up ( (with approx. 1 day between pre- and posttreatment and 4 weeks between pretreatment and follow-up)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women using oral contraceptives (OC) Specific phobia (spider phobia) Exclusion Criteria: Body Mass Index (BMI) < 19 or > 27 Pregnancy Any acute or chronic mental, somatic, endocrine, or metabolic disease Psychological, psychiatric, neurological or pharmacological treatment Shift work Smoking more than 5 cigarettes per month Vaccination in the past 2 month Drug or alcohol abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armin Zlomuzica, PhD
Organizational Affiliation
Ruhr-University Bochum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mental Health Research and Treatment Center
City
Bochum
ZIP/Postal Code
44787
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18403130
Citation
Schwabe L, Haddad L, Schachinger H. HPA axis activation by a socially evaluated cold-pressor test. Psychoneuroendocrinology. 2008 Jul;33(6):890-5. doi: 10.1016/j.psyneuen.2008.03.001. Epub 2008 Apr 9.
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Effects of Stress on Exposure Therapy

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