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

NCT03157622 | Completed

• 1 other identifier: 2015-17k
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

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

  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

  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

  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

  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

  from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion)

Study Arms (2)

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.

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.

Behavioral: Cognitive Behavioural Psychotherapy

Interventions

Exposure in vivo BEHAVIORAL

10 sessions based on an individualized fear hierarchy

Exposure in vivo

Cognitive Behavioural Psychotherapy BEHAVIORAL

graded activity, relaxation techniques and cognitive interventions

Cognitive Behavioral Psychotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philipps University Marburg: lead
• Psychotherapie-Ambulanz Marburg e.V.: collaborator

Study Sites (1)

Philipps University Marburg, Department of Clinical Psychology and Psychotherapy

Marburg, 35037, Germany

Location

Related Links

• CV of Principle Investigator

Study Officials

• Julia Anna Glombiewski

  Philipps-University Marburg, Departement of Clinical PSychology and Psychotherapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Julia A. Glombiewski

Study Record Dates

• First Submitted: November 10, 2015
• First Posted: May 17, 2017
• Study Start: June 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 5, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)