Therapeutic Strategies During Exposure to Pain in an Experimental Design

Not Applicable

Completed

• Conditions: Pain, Acute
• Interventions: Behavioral: Exposure therapy (according to habituation approach); Behavioral: Exposure therapy (according to inhibitory learning approach)

• 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

Arm && Interventions

Group	Intervention	Description
Habituation	Exposure therapy (according to habituation approach)	The habituation instruction focuses on changes of the initial physical fear-responses during exposure sessions. It is explained that the level of anxiety will gradually decrease, or habituate, each time someone faces a feared situation. Participants are then instructed to observe their own level of fear during the three practice trials with the thermode. Together with the experimenter, participants have to indicate their level of arousal on an 11-point scale (0= neutral, 10 = very high) in-between and after the three practice trials. After the practice trial, participants are instructed to reconsider their own development of physical responses. Participants are encouraged to remember the development of their level of arousal during the test trail with the thermode.
Expectation Violation	Exposure therapy (according to inhibitory learning approach)	The expectation violation instruction focuses on the verification of negative expectancies during exposures sessions. It is explained that exposure exercises help to create own experiences which allow to directly test negative predicted outcomes. Together with the experimenter, participants are then encouraged to formulate concrete concerns in regard to the practice trail with the thermode. Before the practice trails, participants have to indicate the likelihood of their concerns on an 11-point scale (0= not likely, 10 = very likely). After the practice trails, participants are instructed to evaluate their own concerns by some guided questions (e.g. "What did you learn?"). Participants are encouraged to keep their own experience in mind during the test trail with the thermode.

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