Clinical trial NCT03146832: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 139
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: participants are assigned to one of three experimental groups in parallel for the duration of the study
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Pain tolerance
timeFrame: 5 minutes prior and 5 minutes after three exposure practice trials
Secondary outcomes:
measure: Pain intensity
timeFrame: 5 minutes prior and 5 minutes after three exposure practice trials
measure: Pain quality
timeFrame: 5 minutes prior and 5 minutes after three exposure practice trials
measure: Pain Catastrophizing Scale (PCS)
timeFrame: 1-week prior and 10 minutes after three exposure practice trials
measure: Pain Anxiety Symptom Scale (PASS)
timeFrame: 1-week prior and 10 minutes after three exposure practice trials
measure: Pain Processing (Fragebogen zur Erfassung der Schmerzverarbeitung, FESV)
timeFrame: 1-week prior and 10 minutes after three exposure practice trials
measure: Psychophysiological activation
timeFrame: throughout the experiment (5 minutes prior, during and 10 minutes after three exposure practice trails
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Philipps University Marburg, Department of Clinical Psychology and Psychotherapy
Study officials:
affiliation: Department of Clinical Psychology and Psychotherapy
name: Julia Anna Glombiewski, Phd
role: PRINCIPAL_INVESTIGATOR
References: