Effects of Stress on Exposure Therapy

Sponsor
Ruhr University of Bochum (Other)
Overall Status
Completed
CT.gov ID
NCT03505437
Collaborator
(none)
48
1
2
16.3
2.9

Study Details

Study Description

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
  • Other: Cold water condition
  • Other: Warm water condition
N/A

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
Actual Enrollment :
48 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 :
Apr 20, 2018
Actual Primary Completion Date :
May 30, 2019
Actual Study Completion Date :
Aug 30, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. 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.

  2. 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.

  3. 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

  4. Blood pressure [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mental Health Research and Treatment Center Bochum Germany 44787

Sponsors and Collaborators

  • Ruhr University of Bochum

Investigators

  • Principal Investigator: Armin Zlomuzica, PhD, Ruhr-University Bochum

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Armin Zlomuzica, Dr. / Principal Investigator, Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT03505437
Other Study ID Numbers:
  • FP 1-2
First Posted:
Apr 23, 2018
Last Update Posted:
Sep 11, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Armin Zlomuzica, Dr. / Principal Investigator, Ruhr University of Bochum
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 11, 2019