NCT03505437

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

April 20, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 23, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
Last Updated

September 11, 2019

Status Verified

September 1, 2019

Enrollment Period

1.1 years

First QC Date

February 1, 2018

Last Update Submit

September 10, 2019

Conditions

Specific Phobia

Keywords

anxiety disordersspider phobiastressexposure therapygeneralization

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 Outcomes (5)

  • 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)

  • 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)

  • Blood pressure

    9 times at Pretreatment

  • 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)

Study Arms (2)

Stress + Exposure

EXPERIMENTAL

Stress Condition: Cold water condition of the socially evaluated cold pressor test (SECPT; Schwabe et al, 2008).

Other: Cold water condition

Control + Exposure

ACTIVE COMPARATOR

Control condition: Warm water condition of the SECPT.

Other: Warm water condition

Interventions

Cold water conditionOTHER

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

Stress + Exposure
Warm water conditionOTHER

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.

Control + Exposure

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women using oral contraceptives (OC)
  • Specific phobia (spider phobia)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mental Health Research and Treatment Center

Bochum, 44787, Germany

Location

Related 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.

    PMID: 18403130BACKGROUND

MeSH Terms

Conditions

Phobia, SpecificAnxiety DisordersArachnophobia

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Armin Zlomuzica, PhD

    Ruhr-University Bochum

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. / Principal Investigator

Study Record Dates

First Submitted

February 1, 2018

First Posted

April 23, 2018

Study Start

April 20, 2018

Primary Completion

May 30, 2019

Study Completion

August 30, 2019

Last Updated

September 11, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)