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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Exposure in vivo

Cognitive Behavioural Psychotherapy

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Chronic Low Back Pain, Cognitive-Behavioural Therapy, Exposure, Therapeutic processes, Single-case study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Philipps University Marburg, Department of Clinical Psychology and Psychotherapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Exposure in vivo

Cognitive Behavioral Psychotherapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Therapeutic changes during the course of treatment compared to baseline

Specifically developed questionnaire on therapeutic change processes

Secondary Outcome Measures

Pain severity at posttest and follow-up compared to baseline pain severity

Brief Pain Inventory, BPI

Pain-related anxiety at posttest and follow-up compared to baseline pain-related anxiety

Pain Anxiety Symptom Scale, PASS- D 20

Pain catastrophizing thoughts at posttest and follow-up compared to baseline pain catastrophizing thoughts

Pain Catastrophizing Scale, PCS

Perceived harmfulness of daily activities at posttest and follow-up compared to baseline perceived harmfulness of daily activities

Photo Series of Daily Actives, Phoda

Pain-related avoidance behavior at posttest and follow-up compared to baseline pain-related avoidance behavior

Behavioral Avoidance Test, BAT Back

Change from baseline in global pain disability at posttest and follow-up compared to baseline global pain disability

Pain Disability Index, PDI

Change from baseline in specific pain disability at posttest and follow-up compared to baseline specific pain disability

Quebec Back Pain Disability Scale, QBPDS

Emotional distress at posttest and follow-up compared to baseline emotional distress

Hospital Anxiety and Depression Scale, HADS

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

Full Information

NCT ID

NCT03157622

First Posted

November 10, 2015

Last Updated

July 3, 2017

Sponsor

Philipps University Marburg Medical Center

Collaborators

Psychotherapie-Ambulanz Marburg e.V.

1. Study Identification

Unique Protocol Identification Number

NCT03157622

Brief Title

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

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

June 2015 (Actual)

Primary Completion Date

June 2017 (Actual)

Study Completion Date

June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Philipps University Marburg Medical Center

Collaborators

Psychotherapie-Ambulanz Marburg e.V.

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Low Back Pain

Keywords

Chronic Low Back Pain, Cognitive-Behavioural Therapy, Exposure, Therapeutic processes, Single-case study

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exposure in vivo

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Cognitive Behavioral Psychotherapy

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Exposure in vivo

Intervention Description

10 sessions based on an individualized fear hierarchy

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Behavioural Psychotherapy

Intervention Description

graded activity, relaxation techniques and cognitive interventions

Primary Outcome Measure Information:

Title

Therapeutic changes during the course of treatment compared to baseline

Description

Specifically developed questionnaire on therapeutic change processes

Time Frame

from baseline phase (1-3 weeks) to intervention phase (5 weeks)

Secondary Outcome Measure Information:

Title

Pain severity at posttest and follow-up compared to baseline pain severity

Description

Brief Pain Inventory, BPI

Time Frame