Chronic Low Back PainNCT03157622
Single-Case Study on Therapeutic Change in Chronic Low Back Pain
A study testing Exposure in vivo and Cognitive Behavioural Psychotherapy in people with Chronic Low Back Pain, run by Philipps University Marburg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Exposure in vivo and Cognitive Behavioural Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2015to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Philipps University Marburg, Department of Clinical Psychology and Psychotherapy
Marburg, 35037
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Low Back Pain
- Being tested
- Exposure in vivo, Cognitive Behavioural Psychotherapy
- Keywords
- Chronic Low Back Pain, Cognitive-Behavioural Therapy, Exposure, Therapeutic processes, Single-case study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure in vivoBehavioural
10 sessions based on an individualized fear hierarchy
Cognitive Behavioural PsychotherapyBehavioural
graded activity, relaxation techniques and cognitive interventions
| Study group | Role | What they receive |
|---|---|---|
| Exposure in vivo | Active comparator | 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. Receives: Behavioral: Exposure in vivo |
| Cognitive Behavioral Psychotherapy | Active comparator | 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. Receives: Behavioral: Cognitive Behavioural Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic changes during the course of treatment compared to baseline
Specifically developed questionnaire on therapeutic change processes
Measured: from baseline phase (1-3 weeks) to intervention phase (5 weeks)
Secondary outcomes (9)
Pain severity at posttest and follow-up compared to baseline pain severity
Brief Pain Inventory, BPI
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study startJun 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Collaborators
- Psychotherapie-Ambulanz Marburg e.V.
- Responsible party
- Principal investigator, Julia Anna Glombiewski, Philipps University Marburg
- Investigators
- Julia Anna Glombiewski, Principal investigator, Philipps-University Marburg, Departement of Clinical PSychology and Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157622
- Sponsor's protocol ID
- 2015-17k
- Status last verified
- Jul 2017
- First submitted
- 10 Nov 2015
- Last updated
- 5 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Therapeutic Change During Exposure and Cognitive-Behavioral Therapy in the Context Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT03157622
- Acronym / sponsor ID
- 2015-17k
- Conditions
- Chronic Low Back Pain
- Keywords
- Chronic Low Back Pain, Cognitive-Behavioural Therapy, Exposure, Therapeutic processes, Single-case study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Collaborators
- Psychotherapie-Ambulanz Marburg e.V.
- Study start
- Jun 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 17 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure in vivo | Active comparator | Behavioral: Exposure in vivoIn 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. |
| Cognitive Behavioral Psychotherapy | Active comparator | Behavioral: Cognitive Behavioural PsychotherapyIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > 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
Key exclusion criteria (8 listed)
- Red flags
- Pregnancy
- Illiteracy
- Psychoses
- Alcohol addiction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure in vivo10 sessions based on an individualized fear hierarchy | Behavioural | Exposure in vivo |
| Cognitive Behavioural Psychotherapygraded activity, relaxation techniques and cognitive interventions | Behavioural | Cognitive Behavioral Psychotherapy |
Primary outcome
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
9 secondary outcomes
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)
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 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)
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2017.
- CV of Principle InvestigatorLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Anna Glombiewski principal investigator
Philipps-University Marburg, Departement of Clinical PSychology and Psychotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure in vivo and Cognitive Behavioural Psychotherapy in people with Chronic Low Back Pain, run by Philipps University Marburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic changes during the course of treatment compared to baseline (time frame: from baseline phase (1-3 weeks) to intervention phase (5 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2017.