Relational world of chronic pain patients in the course of an inpatient multimodal pain treatment focusing on psychosomatic interventions
Organizational Data
- DRKS-ID:
- DRKS00010256
- Recruitment Status:
- Recruiting complete, study continuing
- Date of registration in DRKS:
- 2016-04-01
- Last update in DRKS:
- 2017-12-07
- Registration type:
- Prospective
Acronym/abbreviation of the study
BECSPIN
URL of the study
No Entry
Brief summary in lay language
In this study we examine the context of chronic pain and the relational world of persons with chronic pain. "Relational world" means the relation and perception of the own body, relations to other persons and, eg. also to the medical system. Body perception or bodily changes play a major role for many medical syndromes. Therefore the treatment of chronic pain under a relational aspect and within a bio-psycho-social model is especially important. The treatment "multimodal pain treatment" stands for a bodily, kognitive, social and behavioural reflection and practice with medical-psychotherapeutic support and guidance. All therapists work with the same concept. The name derives from many (lat. multi) kinds of (lat. modi) of treatment. The study results in evaluating a clinical offer and also has impact on applied sciences.
Brief summary in scientific language
The improvement of the quality of life (QoL) of chronic pain patients is the primary goal of treatment. There is only little data about how a multimodal inpatient treatment with focus on psychotherapy has impact on salutegenetic processes via changes in pain detection and interoception. Especially in groups social issues can be made perceivable and being changed. Thus outpatient disorder-specific group therapy has been described and its promising outcomes has been reported on case-report level. So far, there are very little data on on group-process and outcome variables in the course of a treatment. The results of this study on interoception should have impact on models of pain syndromes and the concept of perceived chronic pain. Moreover they serve the evaluation of an existing clinical offer and the exploration of clinical impact factors with a direct benefit on disorder-specific diagnostic assessments and treatment planning.
Health condition or problem studied
- ICD10:
- F45.41
- ICD10:
- F45.40
- Free text:
- Chronic pain
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Patients who meet the criteria for the multimodal pain treatment and who decided to do the therapy after visiting an information group. The criteria are written down by the German Institute for medicial documentation and information (DIMDI) and comprise: A patient has to suffer from chronic (> 6 month) pain and has to meet additionally 3 criteria of the following list: mental comorbidity that is supportive to the pain disorder, severe physical comorbidity, already existing or imminent impairment of quality of life and/or sickness absence, failure of a previous unimodal pain therapy, of a pain related surgical intervention or a withdrawal intervention, drug misuse Data will be assessed via self-report questionnaires and electrocardiogram (ECG).
Endpoints
- Primary outcome:
- Dimensions of interoception: interoceptive accuracy, interoceptive sensibility and interoceptive awareness, as well as autonomous processes measured as (change in) vagal activity (via heart rate variability, HRV) (measured only in T1, T2, T3, T5). HRV and interoceptive accuracy are assessed via ECG with electrodes on the upper body (BIOPAC enhancer). This definitely is a non-invasive procedure. Interoceptive sensibility and awareness are assessed via body perception questionnaire (self-report). Timetable measures: T0-baseline, T1 start of the 5-week intervention, T2 2 weeks after start of the 5-week intervention, T3 end of 5-week intervention, T4 3 month after end of intervention, T5 12 month after end of intervention.
- Secondary outcome:
- All measures are assessed via self-reported questionnaires. Assessment baseline/T0: Pain history, utilisation (items adapted from the German Pain Questionnaire) and childhood trauma (Childhood Trauma Questionnaire). Assessment all measuring times T0-T5: Quality of life (SF-12), pain intensity and frequency (items adapted from the German Pain Questionnaire), clinical mental health (PHQ-9,-15-,-7). Assessment T1, T3, T4, T5: Empathie (Levels of emotional awareness scale & Empathy Quotient , Progredienzangst). During the 5-week intervention quality of therapeutic relationships within small groups will be assessed weekly as process variable with the Group Questionnaire (GQ-D).
Study Design
- Purpose:
- Treatment
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study continuing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Klinik für Psychosomatische Medizin und Psychotherapie Ulm
Recruitment period and number of participants
- Planned study start date:
- 2016-04-06
- Actual study start date:
- 2016-04-06
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 30
- Final Sample Size:
- 35
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Diagnosis of F45.41 or F45.40, having had a consultation in the outpatient unit and having taken part in the information group before deciding to take part in the treatment program.
Exclusion Criteria
not taking part in the treatment program
Addresses
Primary Sponsor
- Address:
- Universitätsklinik für Psychosomatische Medizin und Psychotherapie, Ulm89081 UlmGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinikum für Psychosomatische Medizin und Psychotherapie, UlmDr. Eva RothermundAlbert-Einstein-Allee 2389081 UlmGermany
- Telephone:
- +49 73150061848
- Fax:
- +49 73150061832
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-ulm.de/struktur/kliniken/psychosomatische-medizin-und-psychotherapie.html
Contact for Public Queries
- Address:
- Universitätsklinikum für Psychosomatische Medizin und Psychotherapie, UlmDr. Eva RothermundAlbert-Einstein-Allee89081 UlmGermany
- Telephone:
- +4973150061848
- Fax:
- +4973150061832
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-ulm.de/struktur/kliniken/psychosomatische-medizin-und-psychotherapie.html
Principal Investigator
- Address:
- Universitätsklinikum für Psychosomatische Medizin und Psychotherapie, UlmDr. Eva RothermundAlbert-Einstein-Allee 2389081 UlmGermany
- Telephone:
- +49 73150061848
- Fax:
- +49 73150061832
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-ulm.de/struktur/kliniken/psychosomatische-medizin-und-psychotherapie.html
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Universitätsklinikum für Psychosomatische Medizin und PsychotherapieAlbert-Einstein-Allee 2389081 UlmGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Universität UlmHelmholtzstr. 2089081 UlmGermany
- Telephone:
- +49-731-50022050
- Fax:
- +49-731-50022036
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2016-02-19
- Ethics committee number:
- 77/16
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2016-03-10
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry