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

July 3, 2017 updated by: Julia Anna Glombiewski, Philipps University Marburg Medical Center

Comparing Therapeutic Change During Exposure and Cognitive-Behavioral Therapy in the Context 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Marburg, Germany, 35037
        • Philipps University Marburg, Department of Clinical Psychology and Psychotherapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
from baseline phase (1-3 weeks) to intervention phase (5 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Philipps University Marburg Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Psychotherapie-Ambulanz Marburg e.V.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Julia Anna Glombiewski, Philipps-University Marburg, Departement of Clinical PSychology and Psychotherapy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015-17k

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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