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Completed

NCT Number: NCT03505437

Effects of Stress on Exposure Therapy

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

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Key information

Conditions

Specific Phobia Anxiety Disorders Arachnophobia Mental Disorders Phobia, Specific

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mental Health Research and Treatment Center

Bochum, 44787, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cold water condition

Other

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

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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)

    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

    Time frame: 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

    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)

    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

    Time frame: 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

    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)

    Alpha amylase will be collected using salivette sampling devices

Sponsors and collaborators

Lead sponsor

Ruhr University of Bochum

Other

Registry information

Official study title

The Impact of Stress on Exposure-based Treatment Outcome

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 23, 2018
Registry last updated
Sep 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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