The Impact of Stress on Exposure-based Treatment Outcome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 48
- Locations
- 2
- Primary Endpoint
- Change in the Behavioral Approach Test (BAT) with spiders (treated fear stimulus)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Stress + Exposure
Stress Condition: Cold water condition of the socially evaluated cold pressor test (SECPT; Schwabe et al, 2008).
Intervention: Cold water condition (Other)
Control + Exposure
Control condition: Warm water condition of the SECPT.
Intervention: Warm water condition (Other)
Outcomes
Primary Outcomes
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.
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 Outcomes
- Change in the Spider-fear Related questionnaires(Pretreatment, Posttreatment, Follow-up (with approx. 1 day between pre- and posttreatment and 4 weeks between pretreatment and follow-up))
- Blood pressure(9 times at Pretreatment)
- Change in the Cockroach-fear related questionnaires(Pretreatment, Posttreatment, Follow-up (with approx. 1 day between pre- and posttreatment and 4 weeks between pretreatment and follow-up))
- Free cortisol concentrations(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))
- Activity of the enzyme alpha amylase(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))
Investigators
Armin Zlomuzica
Dr. / Principal Investigator
Ruhr University of Bochum