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Single-Case Study on Therapeutic Change in Chronic Low Back Pain

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ClinicalTrials.gov Identifier: NCT03157622
Recruitment Status : Completed
First Posted : May 17, 2017
Last Update Posted : July 5, 2017
Sponsor:
Collaborator:
Psychotherapie-Ambulanz Marburg e.V.
Information provided by (Responsible Party):
Julia Anna Glombiewski, Philipps University Marburg Medical Center

Brief Summary:
Exploration of treatment processes during exposure and cognitive-behavioral therapy in the context of chronic low back pain in a multiple baseline single-case design.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Behavioral: Exposure in vivo Behavioral: Cognitive Behavioural Psychotherapy Not Applicable

Detailed Description:
The present study intends to specifically investigate treatment elements during exposure and cognitive-behavioral therapy, which are especially powerful in electing time contingent therapeutic change. hereby, it is the goal to explore further change processes, which play an important role during psychological treatment of individuals with CLBP and high levels of fear-avoidance.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparing Therapeutic Change During Exposure and Cognitive-Behavioral Therapy in the Context Chronic Low Back Pain
Actual Study Start Date : June 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Active Comparator: Exposure in vivo
In the Exposure in vivo (EXP) condition, patients are given a careful explanation of the fear-avoidance model. Patients are encouraged to adopt the model to their individual situation. Factors for the maintenance of chronic pain (such as pain cognitions and pain-related fear) are discussed. Especially, negative consequences of avoidance behavior are highlighted. In preparation of the exposure sessions, patients develop an individual fear hierarchy using the Photo Series of Daily Actives. Subsequently, patients are encouraged to test their fear-avoidance beliefs during behavioral experiments and to reduce avoidance behaviors during individually tailored exposure exercises.
Behavioral: Exposure in vivo
10 sessions based on an individualized fear hierarchy

Active Comparator: Cognitive Behavioral Psychotherapy
In the Cognitive Behavioral Psychotherapy (CBT) condition, patients are introduced to several strategies to improve their pain management. The principle of graded activity encourages patients to re-engage in former activities by dividing these activities into smaller steps. Predetermined resting periods are offered as a form to prevent patients from phases of excessive demands followed by long terms of recovery. Progressive muscle relaxation is introduced as a technique to improve the experience of pain. The strategy of attention shifting is presented to change their perception of pain. Maladaptive pain-related cognitions are identified and challenged by cognitive interventions.
Behavioral: Cognitive Behavioural Psychotherapy
graded activity, relaxation techniques and cognitive interventions




Primary Outcome Measures :
  1. Therapeutic changes during the course of treatment compared to baseline [ Time Frame: from baseline phase (1-3 weeks) to intervention phase (5 weeks) ]
    Specifically developed questionnaire on therapeutic change processes


Secondary Outcome Measures :
  1. Pain severity at posttest and follow-up compared to baseline pain severity [ Time Frame: from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion) ]
    Brief Pain Inventory, BPI

  2. Pain-related anxiety at posttest and follow-up compared to baseline pain-related anxiety [ Time Frame: from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion) ]
    Pain Anxiety Symptom Scale, PASS- D 20

  3. Pain catastrophizing thoughts at posttest and follow-up compared to baseline pain catastrophizing thoughts [ Time Frame: from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion) ]
    Pain Catastrophizing Scale, PCS

  4. Perceived harmfulness of daily activities at posttest and follow-up compared to baseline perceived harmfulness of daily activities [ Time Frame: from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion) ]
    Photo Series of Daily Actives, Phoda

  5. Pain-related avoidance behavior at posttest and follow-up compared to baseline pain-related avoidance behavior [ Time Frame: from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion) ]
    Behavioral Avoidance Test, BAT Back

  6. Change from baseline in global pain disability at posttest and follow-up compared to baseline global pain disability [ Time Frame: from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion) ]
    Pain Disability Index, PDI

  7. Change from baseline in specific pain disability at posttest and follow-up compared to baseline specific pain disability [ Time Frame: from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion) ]
    Quebec Back Pain Disability Scale, QBPDS

  8. Emotional distress at posttest and follow-up compared to baseline emotional distress [ Time Frame: from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion) ]
    Hospital Anxiety and Depression Scale, HADS

  9. Biological stress markers distress at posttest and follow-up compared to baseline biological stress markers [ Time Frame: from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion) ]
    collection of salivary cortisol using SaliCaps during the behavioral test, collection of hair samples



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • > 6 months chronic low back pain
  • Sufficient level on fear avoidance scores (PCS > 35, PASS >20, QBPDS > 30, PDI > 20 and Phoda harm ratings of 13 activities > 50, including 8 > 80)
  • German-speaking
  • Agreeing to participate, verified by completion of informed consent

Exclusion Criteria:

  • Red flags
  • Pregnancy
  • Illiteracy
  • Psychoses
  • Alcohol addiction
  • Surgeries during the last 6 months or planed surgeries
  • Specific medical disorders or cardiovascular diseases preventing participation in physical exercise
  • Participating in another psychotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03157622


Locations
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Germany
Philipps University Marburg, Department of Clinical Psychology and Psychotherapy
Marburg, Germany, 35037
Sponsors and Collaborators
Philipps University Marburg Medical Center
Psychotherapie-Ambulanz Marburg e.V.
Investigators
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Principal Investigator: Julia Anna Glombiewski Philipps-University Marburg, Departement of Clinical PSychology and Psychotherapy
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Responsible Party: Julia Anna Glombiewski, Dr. Julia A. Glombiewski, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT03157622    
Other Study ID Numbers: 2015-17k
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: July 5, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Julia Anna Glombiewski, Philipps University Marburg Medical Center:
Chronic Low Back Pain
Cognitive-Behavioural Therapy
Exposure
Therapeutic processes
Single-case study
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations