Effects of Stress on Exposure Therapy

Not Applicable

Completed

• Conditions: Specific Phobia
• Interventions: Other: Warm water condition; Other: Cold water condition

• Registration Number: NCT03505437
• Lead Sponsor: Ruhr University of Bochum

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 Timeline

• Study First Submitted: 2018-02-01
• Study Start: 2018-04-20
• Study First Submitted QC: 2018-04-20
• Study First Posted: 2018-04-23
• Primary Completion: 2019-05-30
• Study Completion: 2019-08-30
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-10
• Last Update Posted: 2019-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control + Exposure	Warm water condition	Control condition: Warm water condition of the SECPT.
Stress + Exposure	Cold water condition	Stress Condition: Cold water condition of the socially evaluated cold pressor test (SECPT; Schwabe et al, 2008).

Primary Outcome Measures

Name	Time	Method
Change in the Behavioral Approach Test (BAT) with spiders (treated fear stimulus)	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)	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

Name	Time	Method
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)	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.
Blood pressure	9 times at Pretreatment	Manipulation check (SECPT). Systolic and diastolic blood pressure (mm/Hg) are measured at different time points
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)	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	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
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)	Alpha amylase will be collected using salivette sampling devices

Trial Locations

Locations (1)

Mental Health Research and Treatment Center; 🇩🇪 Bochum, Germany