Effects of Stress on Exposure Therapy

Specific Phobia Clinical Trial

Official title:

The Impact of Stress on Exposure-based Treatment Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03505437
• Other study ID #: FP 1-2
• Status: Completed
• Phase: N/A
• Start date: April 20, 2018
• Est. completion date: August 30, 2019

Study information

• Verified date: September 2019
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 30, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Phobic Disorders
• Specific Phobia

Intervention

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
• 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.

Locations

Country	Name	City	State
Germany	Mental Health Research and Treatment Center	Bochum

Sponsors (1)

Lead Sponsor	Collaborator
Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Pretreatment, Posttreatment, Follow-up (with approx. 1 day between pre- and posttreatment and 4 weeks between pretreatment and follow-up)
Primary	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.	Pretreatment, Follow-up (with approx. 4 weeks between pretreatment and follow-up)
Secondary	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.	Pretreatment, Posttreatment, Follow-up (with approx. 1 day between pre- and posttreatment and 4 weeks between pretreatment and follow-up)
Secondary	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.	Pretreatment, Posttreatment, Follow-up (with approx. 1 day between pre- and posttreatment and 4 weeks between pretreatment and follow-up)
Secondary	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	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)
Secondary	Blood pressure	Manipulation check (SECPT). Systolic and diastolic blood pressure (mm/Hg) are measured at different time points	9 times at Pretreatment
Secondary	Activity of the enzyme alpha amylase	Alpha amylase will be collected using salivette sampling devices	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)