Therapeutic Strategies During Exposure to Pain in an Experimental Design

Not Applicable

Completed

• Conditions: Pain, Acute

• Registration Number: NCT03146832
• Lead Sponsor: Philipps University Marburg Medical Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-04-01
• Study First Submitted: 2017-04-18
• Study First Submitted QC: 2017-05-09
• Study First Posted: 2017-05-10
• Primary Completion: 2017-06-15
• Study Completion: 2017-06-15
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-03
• Last Update Posted: 2017-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 139

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain tolerance	5 minutes prior and 5 minutes after three exposure practice trials	Determined by the temperature at which the participant stopped the heat stimulus

Secondary Outcome Measures

Name	Time	Method
Pain quality	5 minutes prior and 5 minutes after three exposure practice trials	Measured on an 11-points scale (0 = bearable; 10 = unbearable)
Pain Processing (Fragebogen zur Erfassung der Schmerzverarbeitung, FESV)	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.")
Psychophysiological activation	throughout the experiment (5 minutes prior, during and 10 minutes after three exposure practice trails	e.g. skin conductance responses, heart rate
Pain intensity	5 minutes prior and 5 minutes after three exposure practice trials	Measured on an 11-point scale (0 = no pain; 10 = worst imaginable pain)
Pain Catastrophizing Scale (PCS)	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.")
Pain Anxiety Symptom Scale (PASS)	1-week prior and 10 minutes after three exposure practice trials	Pain-related anxiety (e.g. "I worry when I am in pain.")

Trial Locations

Locations (1)

Philipps University Marburg, Department of Clinical Psychology and Psychotherapy; 🇩🇪 Marburg, Germany