Therapeutic Strategies During Exposure to Pain in an Experimental Design

NCT ID: NCT03146832

Last Updated: 2017-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2017-06-15

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.

Conditions

Pain, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Exposure therapy (according to habituation approach)

Intervention Type: BEHAVIORAL

Exposure instruction focuses on fear reduction during exposure sessions

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.

Group Type: EXPERIMENTAL

Exposure therapy (according to inhibitory learning approach)

Intervention Type: BEHAVIORAL

Exposure instruction focuses on expectation violation during exposure sessions

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exposure therapy (according to habituation approach)

Exposure instruction focuses on fear reduction during exposure sessions

Intervention Type: BEHAVIORAL

Exposure therapy (according to inhibitory learning approach)

Exposure instruction focuses on expectation violation during exposure sessions

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Philipps University Marburg

OTHER

Sponsor Role: lead

Responsible Party

Julia Anna Glombiewski

Ph.D, Licensed Psychologist, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julia Anna Glombiewski, Phd

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Psychology and Psychotherapy

Locations

Philipps University Marburg, Department of Clinical Psychology and Psychotherapy

Marburg, , Germany

Countries

Germany

Other Identifiers

2016-33v

Identifier Type: -

Identifier Source: org_study_id