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Effects of Stress on Exposure Therapy

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ClinicalTrials.gov Identifier: NCT03505437
Recruitment Status : Recruiting
First Posted : April 23, 2018
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Armin Zlomuzica, Ruhr University of Bochum

Brief Summary:
This study investigates whether stress can augment exposure therapy outcome in patients with specific phobia (spider phobia).

Condition or disease Intervention/treatment Phase
Specific Phobia Other: Cold water condition Other: Warm water condition Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: The Impact of Stress on Exposure-based Treatment Outcome
Actual Study Start Date : April 20, 2018
Estimated Primary Completion Date : February 15, 2020
Estimated Study Completion Date : February 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Phobias

Arm Intervention/treatment
Experimental: Stress + Exposure
Stress Condition: Cold water condition of the socially evaluated cold pressor test (SECPT; Schwabe et al, 2008).
Other: Cold water condition
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

Active Comparator: Control + Exposure
Control condition: Warm water condition of the SECPT.
Other: Warm water condition
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 Measures :
  1. Change in the Behavioral Approach Test (BAT) with spiders (treated fear stimulus) [ Time Frame: Pretreatment, Posttreatment, Follow-up (with approx. 1 day between pre- and posttreatment and 4 weeks between pretreatment and follow-up) ]
    During the Behavioral Approach Test (BAT) the closest distance to a spider as well as subjective fear and heart rate is measured.

  2. Change in the Behavioral Approach Test with Cockroaches (untreated fear stimulus) [ Time Frame: Pretreatment, Follow-up (with approx. 4 weeks between pretreatment and follow-up) ]
    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 :
  1. Change in the Spider-fear Related questionnaires [ Time Frame: Pretreatment, Posttreatment, Follow-up (with approx. 1 day between pre- and posttreatment and 4 weeks between pretreatment and follow-up) ]
    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.

  2. Change in the Cockroach-fear related questionnaires [ Time Frame: Pretreatment, Posttreatment, Follow-up (with approx. 1 day between pre- and posttreatment and 4 weeks between pretreatment and follow-up) ]
    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.

  3. Free cortisol concentrations [ 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) ]
    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

  4. Blood pressure [ Time Frame: 9 times at Pretreatment ]
    Manipulation check (SECPT). Systolic and diastolic blood pressure (mm/Hg) are measured at different time points

  5. 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) ]
    Alpha amylase will be collected using salivette sampling devices



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505437


Contacts
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Contact: Armin Zlomuzica, PhD +492343222347 armin.zlomuzica@rub.de

Locations
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Germany
Mental Health Research and Treatment Center Recruiting
Bochum, Germany, 44787
Sponsors and Collaborators
Ruhr University of Bochum
Investigators
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Principal Investigator: Armin Zlomuzica, PhD Ruhr-University Bochum

Publications:
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Responsible Party: Armin Zlomuzica, Dr. / Principal Investigator, Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT03505437     History of Changes
Other Study ID Numbers: FP 1-2
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Armin Zlomuzica, Ruhr University of Bochum:
anxiety disorders
spider phobia
stress
exposure therapy
generalization

Additional relevant MeSH terms:
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Phobic Disorders
Anxiety Disorders
Mental Disorders