Clinical trial NCT03157622: Single-Case Study on Therapeutic Change in Chronic Low Back Pain
Official title: Comparing Therapeutic Change During Exposure and Cognitive-Behavioral Therapy in the Context Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: Chronic Low Back Pain
Cognitive-Behavioural Therapy
Exposure
Therapeutic processes
Single-case study
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
Collaborators: name: Psychotherapie-Ambulanz Marburg e.V.
First posted: 2017-05-17
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Therapeutic changes during the course of treatment compared to baseline
timeFrame: from baseline phase (1-3 weeks) to intervention phase (5 weeks)
Secondary outcomes:
measure: Pain severity at posttest and follow-up compared to baseline pain severity
timeFrame: from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion)
measure: Pain-related anxiety at posttest and follow-up compared to baseline pain-related anxiety
timeFrame: from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion)
measure: Pain catastrophizing thoughts at posttest and follow-up compared to baseline pain catastrophizing thoughts
timeFrame: from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion)
measure: Perceived harmfulness of daily activities at posttest and follow-up compared to baseline perceived harmfulness of daily activities
timeFrame: from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion)
measure: Pain-related avoidance behavior at posttest and follow-up compared to baseline pain-related avoidance behavior
timeFrame: from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion)
measure: Change from baseline in global pain disability at posttest and follow-up compared to baseline global pain disability
timeFrame: from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion)
measure: Change from baseline in specific pain disability at posttest and follow-up compared to baseline specific pain disability
timeFrame: from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion)
measure: Emotional distress at posttest and follow-up compared to baseline emotional distress
timeFrame: from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion)
measure: Biological stress markers distress at posttest and follow-up compared to baseline biological stress markers
timeFrame: from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion)
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Philipps University Marburg, Department of Clinical Psychology and Psychotherapy
Study officials:
affiliation: Philipps-University Marburg, Departement of Clinical PSychology and Psychotherapy
name: Julia Anna Glombiewski
role: PRINCIPAL_INVESTIGATOR
References: