Clinical trial NCT03505437: Effects of Stress on Exposure Therapy
Official title: The Impact of Stress on Exposure-based Treatment Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Specific Phobia
Keywords: anxiety disorders
spider phobia
stress
exposure therapy
generalization
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2018-04-23
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

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

Primary outcomes:
measure: Change in the Behavioral Approach Test (BAT) with spiders (treated fear stimulus)
timeFrame: Pretreatment, Posttreatment, Follow-up (with approx. 1 day between pre- and posttreatment and 4 weeks between pretreatment and follow-up)
measure: Change in the Behavioral Approach Test with Cockroaches (untreated fear stimulus)
timeFrame: Pretreatment, Follow-up (with approx. 4 weeks between pretreatment and follow-up)
Secondary outcomes:
measure: Change in the Spider-fear Related questionnaires
timeFrame: Pretreatment, Posttreatment, Follow-up (with approx. 1 day between pre- and posttreatment and 4 weeks between pretreatment and follow-up)
measure: Change in the Cockroach-fear related questionnaires
timeFrame: Pretreatment, Posttreatment, Follow-up (with approx. 1 day between pre- and posttreatment and 4 weeks between pretreatment and follow-up)
measure: Free cortisol concentrations
timeFrame: 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)
measure: Blood pressure
timeFrame: 9 times at Pretreatment
measure: Activity of the enzyme alpha amylase
timeFrame: 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)
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Mental Health Research and Treatment Center
Study officials:
affiliation: Ruhr-University Bochum
name: Armin Zlomuzica, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.