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Therapeutic Strategies During Exposure to Pain in an Experimental Design

Primary Purpose

Pain, Acute

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Exposure therapy (according to habituation approach)
Exposure therapy (according to inhibitory learning approach)
Sponsored by
Philipps University Marburg Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Acute

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Philipps University Marburg, Department of Clinical Psychology and Psychotherapy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Habituation

Expectation Violation

Control

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain intensity
Measured on an 11-point scale (0 = no pain; 10 = worst imaginable pain)
Pain quality
Measured on an 11-points scale (0 = bearable; 10 = unbearable)
Pain Catastrophizing Scale (PCS)
Pain catastrophizing thoughts (e.g. "I worry all the time about whether the pain will end.")
Pain Anxiety Symptom Scale (PASS)
Pain-related anxiety (e.g. "I worry when I am in pain.")
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.")
Psychophysiological activation
e.g. skin conductance responses, heart rate

Full Information

First Posted
April 18, 2017
Last Updated
July 3, 2017
Sponsor
Philipps University Marburg Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03146832
Brief Title
Therapeutic Strategies During Exposure to Pain in an Experimental Design
Official Title
Exposure Works, But How? Testing Different Therapeutic Strategies During Exposure to Pain in an Experimental Design
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
June 15, 2017 (Actual)
Study Completion Date
June 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Philipps University Marburg Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
participants are assigned to one of three experimental groups in parallel for the duration of the study
Masking
Participant
Masking Description
Participants were not aware which experimental condition they were allocated to.
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Habituation
Arm Type
Experimental
Arm Description
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.
Arm Title
Expectation Violation
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exposure therapy (according to habituation approach)
Intervention Description
Exposure instruction focuses on fear reduction during exposure sessions
Intervention Type
Behavioral
Intervention Name(s)
Exposure therapy (according to inhibitory learning approach)
Intervention Description
Exposure instruction focuses on expectation violation during exposure sessions
Primary Outcome Measure Information:
Title
Pain tolerance
Description
Determined by the temperature at which the participant stopped the heat stimulus
Time Frame
5 minutes prior and 5 minutes after three exposure practice trials
Secondary Outcome Measure Information:
Title
Pain intensity
Description
Measured on an 11-point scale (0 = no pain; 10 = worst imaginable pain)
Time Frame
5 minutes prior and 5 minutes after three exposure practice trials
Title
Pain quality
Description
Measured on an 11-points scale (0 = bearable; 10 = unbearable)
Time Frame
5 minutes prior and 5 minutes after three exposure practice trials
Title
Pain Catastrophizing Scale (PCS)
Description
Pain catastrophizing thoughts (e.g. "I worry all the time about whether the pain will end.")
Time Frame
1-week prior and 10 minutes after three exposure practice trials
Title
Pain Anxiety Symptom Scale (PASS)
Description
Pain-related anxiety (e.g. "I worry when I am in pain.")
Time Frame
1-week prior and 10 minutes after three exposure practice trials
Title
Pain Processing (Fragebogen zur Erfassung der Schmerzverarbeitung, FESV)
Description
Cognitive pain coping strategies (e.g. "When I am in pain, I know several possibilities how to handle them.")
Time Frame
1-week prior and 10 minutes after three exposure practice trials
Title
Psychophysiological activation
Description
e.g. skin conductance responses, heart rate
Time Frame
throughout the experiment (5 minutes prior, during and 10 minutes after three exposure practice trails

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Anna Glombiewski, Phd
Organizational Affiliation
Department of Clinical Psychology and Psychotherapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Philipps University Marburg, Department of Clinical Psychology and Psychotherapy
City
Marburg
ZIP/Postal Code
35037
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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Therapeutic Strategies During Exposure to Pain in an Experimental Design

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