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Completed

NCT Number: NCT03157622

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

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.

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Key information

Conditions

Chronic Low Back Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Philipps University Marburg, Department of Clinical Psychology and Psychotherapy

Marburg, 35037, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exposure in vivo

Behavioral

10 sessions based on an individualized fear hierarchy

Cognitive Behavioural Psychotherapy

Behavioral

graded activity, relaxation techniques and cognitive interventions

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Philipps University Marburg

Other

Collaborators

  • Psychotherapie-Ambulanz Marburg e.V.

Registry information

Official study title

Comparing Therapeutic Change During Exposure and Cognitive-Behavioral Therapy in the Context Chronic Low Back Pain

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 17, 2017
Registry last updated
Jul 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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