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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03146832
Enrollment
139
Registered
2017-05-10
Start date
2017-04-01
Completion date
2017-06-15
Last updated
2017-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Acute

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.

Interventions

BEHAVIORALExposure therapy (according to habituation approach)

Exposure instruction focuses on fear reduction during exposure sessions

BEHAVIORALExposure therapy (according to inhibitory learning approach)

Exposure instruction focuses on expectation violation during exposure sessions

Sponsors

Philipps University Marburg
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Participants were not aware which experimental condition they were allocated to.

Intervention model description

participants are assigned to one of three experimental groups in parallel for the duration of the study

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Pain tolerance5 minutes prior and 5 minutes after three exposure practice trialsDetermined by the temperature at which the participant stopped the heat stimulus

Secondary

MeasureTime frameDescription
Pain quality5 minutes prior and 5 minutes after three exposure practice trialsMeasured on an 11-points scale (0 = bearable; 10 = unbearable)
Pain Catastrophizing Scale (PCS)1-week prior and 10 minutes after three exposure practice trialsPain catastrophizing thoughts (e.g. I worry all the time about whether the pain will end.)
Pain intensity5 minutes prior and 5 minutes after three exposure practice trialsMeasured on an 11-point scale (0 = no pain; 10 = worst imaginable pain)
Pain Processing (Fragebogen zur Erfassung der Schmerzverarbeitung, FESV)1-week prior and 10 minutes after three exposure practice trialsCognitive pain coping strategies (e.g. When I am in pain, I know several possibilities how to handle them.)
Psychophysiological activationthroughout the experiment (5 minutes prior, during and 10 minutes after three exposure practice trailse.g. skin conductance responses, heart rate
Pain Anxiety Symptom Scale (PASS)1-week prior and 10 minutes after three exposure practice trialsPain-related anxiety (e.g. I worry when I am in pain.)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026