Specific PhobiaNCT03505437
Effects of Stress on Exposure Therapy
A study testing Cold water condition and Warm water condition in people with Specific Phobia, run by Ruhr University of Bochum at 1 site in Germany.
Trial summary
This study investigates whether stress can augment exposure therapy outcome in patients with specific phobia (spider phobia). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Specific Phobia
- What is being tested?
- Cold water condition and Warm water condition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteGermany
- Study dates
- 20 Apr 2018to 30 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women using oral contraceptives (OC)
- Specific phobia (spider phobia)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Stress on Exposure-based Treatment Outcome
This study investigates whether stress can augment exposure therapy outcome in patients with specific phobia (spider phobia).
Read the 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).
- Conditions
- Specific Phobia
- Being tested
- Cold water condition, Warm water condition
- Keywords
- anxiety disorders, spider phobia, stress, exposure therapy, generalization
- Medical subject headings
- Phobia, Specific, Anxiety Disorders, Arachnophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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.
| Study group | Role | What they receive |
|---|---|---|
| Stress + Exposure | Experimental | Stress Condition: Cold water condition of the socially evaluated cold pressor test (SECPT; Schwabe et al, 2008). Receives: Other: Cold water condition |
| Control + Exposure | Active comparator | Control condition: Warm water condition of the SECPT. Receives: Other: Warm water condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: Pretreatment, Follow-up (with approx. 4 weeks between pretreatment and follow-up)
Secondary outcomes (5)
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.
Measured: 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
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.
Measured: Pretreatment, Posttreatment, Follow-up (with approx. 1 day between pre- and posttreatment and 4 weeks between pretreatment and follow-up)
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
Measured: 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
Manipulation check (SECPT). Systolic and diastolic blood pressure (mm/Hg) are measured at different time points
Measured: 9 times at Pretreatment
Activity of the enzyme alpha amylase
Alpha amylase will be collected using salivette sampling devices
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start20 Apr 2018
- Primary completion30 May 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Specific PhobiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Armin Zlomuzica, Ruhr University of Bochum
- Investigators
- Armin Zlomuzica, PhD, Principal investigator, Ruhr-University Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505437
- Sponsor's protocol ID
- FP 1-2
- Status last verified
- Sep 2019
- First submitted
- 1 Feb 2018
- Last updated
- 11 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18403130
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Stress on Exposure-based Treatment Outcome
- ClinicalTrials.gov ID
- NCT03505437
- Acronym / sponsor ID
- FP 1-2
- Conditions
- Specific Phobia
- Keywords
- anxiety disorders, spider phobia, stress, exposure therapy, generalization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- 20 Apr 2018 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 23 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress + Exposure | Experimental | Other: Cold water conditionStress Condition: Cold water condition of the socially evaluated cold pressor test (SECPT; Schwabe et al, 2008). |
| Control + Exposure | Active comparator | Other: Warm water conditionControl condition: Warm water condition of the SECPT. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women using oral contraceptives (OC)
- Specific phobia (spider phobia)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold water conditionCold 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 | Other | Stress + Exposure |
| Warm water conditionWarm 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. | Other | Control + Exposure |
Primary outcome
Change in the Behavioral Approach Test (BAT) with spiders (treated fear stimulus)
Time frame: 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)
Time frame: 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.
5 secondary outcomes
Change in the Spider-fear Related questionnaires
Time frame: 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
Time frame: Pretreatment, Posttreatment, Follow-up (with approx. 1 day between pre- and posttreatment and 4 weeks between pretreatment and follow-up)
Free cortisol concentrations
Time frame: 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
Time frame: 9 times at Pretreatment
Activity of the enzyme alpha amylase
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
- Background: PubMed 18403130Schwabe 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.
- Individual participant dataSharing planned: No
Related trials for Specific Phobia
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
Not yet recruiting
Effects of Dead Bug Exercises With and Without Diaphragmatic Breathing in Patients With Chronic Non-specific Low Back Pain.
Non-specific Chronic Low Back Pain
Not yet recruiting
Facing Fears From Home: Development, Feasibility and Maximization of FobiApp
Specific Phobia
Recruiting
Anxiety Skills Study
Anxiety, Anxiety Acute
Recruiting
Metacognitive Therapy Compared to Cognitive-behavioral Therapy
Generalized Anxiety Disorder, Social Anxiety Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armin Zlomuzica, PhD principal investigator
Ruhr-University Bochum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold water condition and Warm water condition in people with Specific Phobia, run by Ruhr University of Bochum at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Behavioral Approach Test (BAT) with spiders (treated fear stimulus) (time frame: Pretreatment, Posttreatment, Follow-up (with approx. 1 day between pre- and posttreatment and 4 weeks between pretreatment and follow-up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03505437, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2019.