Skip to main content
OpenTrials
Completed

NCT Number: NCT03146832

Therapeutic Strategies During Exposure to Pain in an Experimental Design

The goal of the present study is to compare different therapeutic strategies (according to habituation model vs. according to the inhibitory learning approach) during exposure to thermal pain in an experimental design.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain, Acute Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Philipps University Marburg, Department of Clinical Psychology and Psychotherapy

Marburg, 35037, Germany

About this study

Exposure therapy is effective for the treatment of individuals with chronic pain and high levels of fear-avoidance. Nevertheless, mechanisms of change for exposure treatment are not sufficiently investigated. According to the habituation model, the activation of a fear structure leads to a habituation of the initial physical response. Therefore, the therapeutic recommendation is to focus on the reduction of fear during exposure sessions. According to the inhibitory learning approach, however, exposure experiences compete with the original US-CS fear association. Therefore, the therapist should maximize the violation of negative expectancies. The present study intends to compare both strategies during the exposure to pain in an experimental design.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • female gender
  • sufficient knowledge of German language

Exclusion criteria

  • chronic and acute pain conditions
  • Raynaud's disease
  • high blood pressure
  • neuropathy, coronary diseases
  • diabetes, current alcohol
  • drug or pain-medication (last 24hours)

Treatment and study plan

Exposure therapy (according to habituation approach)

Behavioral

Exposure instruction focuses on fear reduction during exposure sessions

Exposure therapy (according to inhibitory learning approach)

Behavioral

Exposure instruction focuses on expectation violation during exposure sessions

Primary outcomes

  1. Pain tolerance

    Time frame: 5 minutes prior and 5 minutes after three exposure practice trials

    Determined by the temperature at which the participant stopped the heat stimulus

Secondary outcomes

  1. Pain intensity

    Time frame: 5 minutes prior and 5 minutes after three exposure practice trials

    Measured on an 11-point scale (0 = no pain; 10 = worst imaginable pain)

  2. Pain quality

    Time frame: 5 minutes prior and 5 minutes after three exposure practice trials

    Measured on an 11-points scale (0 = bearable; 10 = unbearable)

  3. Pain Catastrophizing Scale (PCS)

    Time frame: 1-week prior and 10 minutes after three exposure practice trials

    Pain catastrophizing thoughts (e.g. "I worry all the time about whether the pain will end.")

  4. Pain Anxiety Symptom Scale (PASS)

    Time frame: 1-week prior and 10 minutes after three exposure practice trials

    Pain-related anxiety (e.g. "I worry when I am in pain.")

  5. Pain Processing (Fragebogen zur Erfassung der Schmerzverarbeitung, FESV)

    Time frame: 1-week prior and 10 minutes after three exposure practice trials

    Cognitive pain coping strategies (e.g. "When I am in pain, I know several possibilities how to handle them.")

  6. Psychophysiological activation

    Time frame: throughout the experiment (5 minutes prior, during and 10 minutes after three exposure practice trails

    e.g. skin conductance responses, heart rate

Sponsors and collaborators

Lead sponsor

Philipps University Marburg

Other

Registry information

Official study title

Exposure Works, But How? Testing Different Therapeutic Strategies During Exposure to Pain in an Experimental Design

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 10, 2017
Registry last updated
Jul 5, 2017

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.