Therapeutic Strategies During Exposure to Pain in an Experimental Design

Exposure Works, But How? Testing Different 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.

Study Overview

• Status: Completed
• Conditions: Pain, Acute
• Intervention / Treatment: Behavioral: Exposure therapy (according to habituation approach); Behavioral: Exposure therapy (according to inhibitory learning approach)

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 Type: Interventional
• Enrollment (Actual): 139
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Marburg, Germany, 35037
    • Philipps University Marburg, Department of Clinical Psychology and Psychotherapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Habituation; 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.	Behavioral: Exposure therapy (according to habituation approach); Exposure instruction focuses on fear reduction during exposure sessions
Experimental: Expectation Violation; 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.	Behavioral: Exposure therapy (according to inhibitory learning approach); Exposure instruction focuses on expectation violation during exposure sessions
No Intervention: Control; Participants in the control group are not provided with information about exposure therapy. Instead, participants listen to a newspaper article which reports on the daily work in a botanical garden. Together with the experimenter, participants are then asked to name the most interesting aspect in the article. Before the practice trails, participants have to rate how likely it is that they would further inform themselves about botanical gardens on an 11-point scale (0= not likely, 10 = very likely). After the practice trails, participants are provided with some further questions about the newspaper article (e.g. "Did you find the newspaper article interesting?"). This cognitive exercise does not cover any pain-related topics and, therefore, does not serve as a distraction instruction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain tolerance	Determined by the temperature at which the participant stopped the heat stimulus	5 minutes prior and 5 minutes after three exposure practice trials

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Measured on an 11-point scale (0 = no pain; 10 = worst imaginable pain)	5 minutes prior and 5 minutes after three exposure practice trials
Pain quality	Measured on an 11-points scale (0 = bearable; 10 = unbearable)	5 minutes prior and 5 minutes after three exposure practice trials
Pain Catastrophizing Scale (PCS)	Pain catastrophizing thoughts (e.g. "I worry all the time about whether the pain will end.")	1-week prior and 10 minutes after three exposure practice trials
Pain Anxiety Symptom Scale (PASS)	Pain-related anxiety (e.g. "I worry when I am in pain.")	1-week prior and 10 minutes after three exposure practice trials
Pain Processing (Fragebogen zur Erfassung der Schmerzverarbeitung, FESV)	Cognitive pain coping strategies (e.g. "When I am in pain, I know several possibilities how to handle them.")	1-week prior and 10 minutes after three exposure practice trials
Psychophysiological activation	e.g. skin conductance responses, heart rate	throughout the experiment (5 minutes prior, during and 10 minutes after three exposure practice trails

Collaborators and Investigators

• Sponsor: Philipps University Marburg Medical Center
• Investigators: Principal Investigator: Julia Anna Glombiewski, Phd, Department of Clinical Psychology and Psychotherapy

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): June 15, 2017
• Study Completion (Actual): June 15, 2017

Study Registration Dates

• First Submitted: April 18, 2017
• First Submitted That Met QC Criteria: May 9, 2017
• First Posted (Actual): May 10, 2017

Study Record Updates

• Last Update Posted (Actual): July 5, 2017
• Last Update Submitted That Met QC Criteria: July 3, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: 2016-33v

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No