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

NCT ID: NCT03157622

Last Updated: 2017-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-06-30

Brief Summary

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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

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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

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Chronic Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Exposure in vivo

Intervention Type BEHAVIORAL

10 sessions based on an individualized fear hierarchy

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.

Group Type ACTIVE_COMPARATOR

Cognitive Behavioural Psychotherapy

Intervention Type BEHAVIORAL

graded activity, relaxation techniques and cognitive interventions

Interventions

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Exposure in vivo

10 sessions based on an individualized fear hierarchy

Intervention Type BEHAVIORAL

Cognitive Behavioural Psychotherapy

graded activity, relaxation techniques and cognitive interventions

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Psychotherapie-Ambulanz Marburg e.V.

OTHER

Sponsor Role collaborator

Philipps University Marburg

OTHER

Sponsor Role lead

Responsible Party

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Julia Anna Glombiewski

Dr. Julia A. Glombiewski

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julia Anna Glombiewski

Role: PRINCIPAL_INVESTIGATOR

Philipps-University Marburg, Departement of Clinical PSychology and Psychotherapy

Locations

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Philipps University Marburg, Department of Clinical Psychology and Psychotherapy

Marburg, , Germany

Site Status

Countries

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Germany

Related Links

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Other Identifiers

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2015-17k

Identifier Type: -

Identifier Source: org_study_id

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