Exposure Therapy and Safety-seeking Behavior in Chronic Low Back Pain

NCT01971151 | Unknown

• 1 other identifier: Exp_SSB_LBP
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Exposure in vivo therapy aims to reduce pain-related fear - a key maintaining factor of chronic low back pain- while increasing level of daily functioning, despite the pain. This is done by exposing patients to their most feared activities/movements, while behavioral experiments are performed that serve to correct catastrophic (erroneous) beliefs about pain. Yet, performing exposure exercises might be very threatening for patients and might encourage them to build in subtle safety-seeking behavior. Whether safety-seeking behavior should be allowed or not during therapy is heavily debated. Whereas some argue that it will only interfere with therapeutic progress because it prevents the disconfirming experience exposure tries to offer, other argue that it will facilitate therapeutic progress because it enhances one's sense of control, if used judiciously. So far (clinical-)experimental studies have provided mixed evidence nor have they lead to any clinical recommendation. Hence, in a replicated single-case experiment, we will compare exposure therapy with versus exposure without safety-seeking behavior versus exposure only. STUDY POPULATION: Participants are chronic low back pain patients seeking treatment, who fulfill all inclusion and exclusion criteria and participate voluntarily. INTERVENTION: All participants receive exposure therapy at the rehabilitation department of the academic hospital in Maastricht, but with different recommendations for the use of safety-seeking behavior. We will assess: 1) daily measures of fear, pain intensity and self-reported achievement of goals and 2) non-daily measures of pain disability, pain-related fear, pain catastrophizing, pain solutions, need to control and safety-seeking behavior. To measure to the influence of safety-seeking behavior on actual level of functioning, two behavioral performance tasks will also be presented, ie. a bag carrying task and a personalized task. BURDEN AND RISKS: There are no risks associated with participation to this study that are not otherwise related to rehabilitation and movement in general and participation is completely voluntary. Participants are requested to fill out questionnaires on a daily basis at home (computerized if possible), as well as on different time points during the study and at follow up and perform two behavioral performance tasks. This study could help to further improve the beneficial long-term effects of exposure.

Conditions

Chronic Low Back Pain

Keywords

Chronic; Back pain; Low back

Outcome Measures

Primary Outcomes (1)

• Change in pain-related fear level from baseline to end of treatment at 9 weeks and to follow-up at 20 weeks to 51 weeks

  Three self-report measures are used: 1) daily measures of fear, 2) The Tampa Scale of Kinesiophobia (TSK): a questionnaire to o assess general level of fear of (re)injury due to movement, 2) The Photograph Series of Daily activities(PHODA) and the PHODA-Short electronic version (PHODA-SeV): a tool to assess the perceived harmfulness of specific daily activities.

  baseline and 9 weeks , 20 weeks, and 51 weeks

Secondary Outcomes (3)

• Change in back pain-related disability from baseline to end of treatment at 9 weeks and to follow-up at 20 weeks and 51 weeks

  baseline, 9 weeks, 20, 51 weeks

• Change in pain from baseline to end of treatment at 9 weeks and to follow up at 20 weeks and 51 weeks

  baseline, 9 weeks, 20 weeks and 51 weeks

• Change in pain catastrophizing from baseline to end of treatment at 9 weeks and to follow up at 20 weeks and 51 weeks

  baseline, 9 weeks, 20 weeks and 51 weeks

Study Arms (3)

Exposure with safety-seeking behavior

EXPERIMENTAL

Patients receive exposure therapy. In the current condition, exposure is offered while patients are allowed to use their own safety-seeking behaviors (i.e., behavior believed to be necessary to prevent a feared catastrophe).

Behavioral: Exposure therapy

Exposure without safety-seeking behavior

EXPERIMENTAL

Patients receive exposure therapy.In the current condition, exposure is offered while patients are instructed to omit their safety-seeking behavior.

Behavioral: Exposure therapy

Exposure therapy only

ACTIVE COMPARATOR

Patients receive exposure therapy. In the current condition, exposure is offered while patients do not receive any specific instructions about what to do with their safety-seeking behavior.

Behavioral: Exposure therapy

Interventions

Exposure therapy BEHAVIORAL

Treatment protocol: 1\) preparation consisting of intake and identification of feared movements, activities and situations and their underlying catastrophic beliefs. 2) education, 3)exposure sessions: patients confront threatening situations and behavioral experiments are performed that are targeted at correcting erroneous catastrophic beliefs. 4) homework assignments.

Also known as: Cognitive-behavioural therapy

Exposure therapy only; Exposure with safety-seeking behavior; Exposure without safety-seeking behavior

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suffer from chronic low back pain not caused by serious spinal injury, for at least 3 to 6 months
• Report a sufficient level of disability (this is in itself already a criterion to start treatment at the Rehabilitation department) and
• Moderate to high levels of pain-related fear (TSK \> 37 or at least 4 items with a score of 3 or \>3)
• Have a partner willing to participate

You may not qualify if:

• Specific medical disorder or cardiovascular disease preventing participation in physical exercise
• Serious psychopathologic co-morbidity. This is checked during anamnesis in the intake session with the rehabilitation physician and during the screening (standard care, see session 1 and session 2). When psychopathologic co-morbidity is detected, patients cannot participate in the study and may not be suitable candidates for exposure therapy entirely. Any decision regarding treatment recommendation is made with the entire treatment team. Furthermore, the researcher performing the therapy has a Master's degree in Clinical Psychology, which adds to the treatment team's expertise on psychopathology.
• Alcohol or drug abuse, i.e., at least one out of the four following criteria needs to be fulfilled: continued use despite social or interpersonal problems; repeated use resulting in failure to fulfill obligations at work, school, or home; repeated use resulting in physically hazardous situations; use resulting in legal problems (according to the Diagnostic Statistical Manual of Mental disorders, 4th ed.). This is assessed by the rehabilitation physician during the first session.
• Illiteracy
• Pregnancy
• Involvement in litigation concerning the patient's ability to work or disability income
• Non-Dutch speaking

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• KU Leuven: collaborator
• Maastricht University: collaborator

Study Sites (1)

Maastricht medical care center, department of rehabilitation

Maastricht, Maastricht, 6202, Netherlands

Location

Related Publications (1)

• Vlaeyen JW, de Jong J, Geilen M, Heuts PH, van Breukelen G. Graded exposure in vivo in the treatment of pain-related fear: a replicated single-case experimental design in four patients with chronic low back pain. Behav Res Ther. 2001 Feb;39(2):151-66. doi: 10.1016/s0005-7967(99)00174-6.

  PMID: 11153970 BACKGROUND

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome; Back Pain

Interventions

Implosive Therapy; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Johan Vlaeyen, PhD

  Maastricht University and University of Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2013
• First Posted: October 29, 2013
• Study Start: February 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 29, 2013

Record last verified: 2013-10

Locations

NL (1)