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

Study Overview
=================
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.

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

Conditions
-----------------
Chronic Low Back Pain

Intervention / Treatment
-----------------
* Behavioral: Exposure in vivo
* Behavioral: Cognitive Behavioural Psychotherapy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exposure in vivo<br>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<br>* 10 sessions based on an individualized fear hierarchy<br>|
| Active Comparator: Cognitive Behavioral Psychotherapy<br>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<br>* graded activity, relaxation techniques and cognitive interventions<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapeutic changes during the course of treatment compared to baseline | Specifically developed questionnaire on therapeutic change processes | from baseline phase (1-3 weeks) to intervention phase (5 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain severity at posttest and follow-up compared to baseline pain severity | Brief Pain Inventory, BPI | 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-related anxiety at posttest and follow-up compared to baseline pain-related anxiety | Pain Anxiety Symptom Scale, PASS- D 20 | 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 thoughts at posttest and follow-up compared to baseline pain catastrophizing thoughts | Pain Catastrophizing Scale, PCS | from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion) | 
| Perceived harmfulness of daily activities at posttest and follow-up compared to baseline perceived harmfulness of daily activities | Photo Series of Daily Actives, Phoda | 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-related avoidance behavior at posttest and follow-up compared to baseline pain-related avoidance behavior | Behavioral Avoidance Test, BAT Back | from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion) | 
| Change from baseline in global pain disability at posttest and follow-up compared to baseline global pain disability | Pain Disability Index, PDI | from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion) | 
| Change from baseline in specific pain disability at posttest and follow-up compared to baseline specific pain disability | Quebec Back Pain Disability Scale, QBPDS | from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion) | 
| Emotional distress at posttest and follow-up compared to baseline emotional distress | Hospital Anxiety and Depression Scale, HADS | from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion) | 
| Biological stress markers distress at posttest and follow-up compared to baseline biological stress markers | collection of salivary cortisol using SaliCaps during the behavioral test, collection of hair samples | from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Low Back Pain, Cognitive-Behavioural Therapy, Exposure, Therapeutic processes, Single-case study