Therapeutic Strategies During Exposure to Pain in an Experimental Design

Pain, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03146832
• Other study ID #: 2016-33v
• Status: Completed
• Phase: N/A
• First received: April 18, 2017
• Last updated: July 3, 2017
• Start date: April 1, 2017
• Est. completion date: June 15, 2017

Study information

• Verified date: July 2017
• Source: Philipps University Marburg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: June 15, 2017
• Est. primary completion date: June 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Pain
• Pain, Acute

Intervention

Behavioral:
• Exposure therapy (according to habituation approach)
Exposure instruction focuses on fear reduction during exposure sessions
• Exposure therapy (according to inhibitory learning approach)
Exposure instruction focuses on expectation violation during exposure sessions

Locations

Country	Name	City	State
Germany	Philipps University Marburg, Department of Clinical Psychology and Psychotherapy	Marburg

Sponsors (1)

Lead Sponsor	Collaborator
Philipps University Marburg Medical Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Pain quality	Measured on an 11-points scale (0 = bearable; 10 = unbearable)	5 minutes prior and 5 minutes after three exposure practice trials
Secondary	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
Secondary	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
Secondary	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
Secondary	Psychophysiological activation	e.g. skin conductance responses, heart rate	throughout the experiment (5 minutes prior, during and 10 minutes after three exposure practice trails