Trial document





This trial has been registered retrospectively.
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  DRKS00013323

Trial Description

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Title

Efficacy of an attachment-based working alliance in multimodal pain treatment - Amendment

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The following study is a follow-up study to the main intervention study (DRKS00008715). To date, the knowledge about attachment concepts has not been used to improve pain treatment outcomes with the help of a differential approach based on individual attachment styles. Therefore, we will compare the short- and long-term treatment outcomes for pain patients who will receive multidisciplinary, attachment-specific treatment with the outcomes for patients in a control group who do not receive any treatment. The main outcomes are pain severity, physical functioning, Oxytocin-level, Oxytocinreceptor Gen, Vasopression and Cortisol in the blood measured at four different time points: T1 (Beginning of treatment/Baseline), T2 (2 weeks after beginning of the treatment - only intervention group), T3 (End of Treatment - only Intervention group) and T4 (3 - months follow-up).

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Brief Summary in Scientific Language

The primary aim of the study is to examine the efficacy of an attachment-based intervention for pain patients (mainly with an insecure attachment style) on pain and also physiological biomarkers such as Oxytocin, Oxytocin receptor Gene, Vasopressin, and Cortisol. The study aims to look at short and log term outcomes effects of an attachment based working alliance.
The primary aim of this study is to examine the association between pain, attachment behaviour and physiological biomarkers in chronic pain patients.
Evaluation of the Oxytocin-level in the treatment process, Comparison of the Cortisol-Level from the beginning of treatment to treatment determination, Identifying of mediators of pain intensity and stress,Association between Oxytocin-level and attachment behaviour, Comparison of securely and insecurely attached patients in regards to pain, Oxytocin-level, Cortisol-level, Vasopressin-Level, Comparison of patients of the intervention group and participants from the control group in regards to the methylation level of the oxytocin receptor gen as well as childhood traumata

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Organizational Data

  •   DRKS00013323
  •   2018/01/16
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  •   yes
  •   Approved
  •   S-305/2013, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   F45.40 -  [generalization F45.4: Persistent somatoform pain disorder]
  •   F45.41 -  [generalization F45.4: Persistent somatoform pain disorder]
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Interventions/Observational Groups

  •   The intervention group receive the standard multimodal pain therapy with an the attachment-based intervention. The have to do an attachment style interview for the determination of the individual attachment style as well as the completion of 4 different questionnaires over the 4 measurement points.

    T1 Beginning of the therapy (ca. 30 min)
    T2 2 weeks after beginning of therapy (ca. 10 min)
    T3 End of Therapy (ca. 30 min)
    T4 3 Months Follow-up (ca. 20 min)

    Blood will be drawn at every of the four measurement points as well.
  •   The control group contains healthy participants that have no chronic pain and that do not receive a pain treatment therapy. They have to fill in a questionnaire at T1 (Baseline) and T2 (3-months follow-up). Blood will be drawn at each measurement point as well.
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

With two Visual Analogue Scales, we assess the pain intensity at present and within the previous week. We also look at the Oxytocin-levels as well as Vasopressin levels at each measurement point. Physical functioning will be assessed with the Oswestry Disability Index by Mannion et al. (2006). Also, we included a widely used German short version of the Health Survey to assess physical functioning and health-related quality of life more generally (Bullinger and Kirchberger, 1998). All of those questionnaires were assessed at T1 (beginning of Treatment), T2 (middle of treatment), T3 (after Treatment) and T4 (3 months after Treatment).

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Secondary Outcome

Assessments of both intervention group and baseline group are identical. Patients’ attachment patterns will be assessed with the help of the relationship questionnaire (RQ 2; Bartholomew and Horowitz, 1991) and the revised Experience of Close Relationships questionnaire (Ehrenthal et al., 2009) in its newly developed German short version (ECR-RD 12; Brenk-Franz, Ehrenthal, et al. Version 1.0, 2011, personal communication) and the attachment style interview at T1 (Treatment begin) and T3 (post-treatment). To measure emotional distress, we included the Depression, Anxiety and Stress Scale (Lovibond and Lovibond, 1995) in its German version by Nilges and colleagues at T1, T2; T3 and T4. For the assessment of patients’ personality based on the five basic personality factors we chose the NEO-Five Factor Inventory (Costa and McCrae, 1989; German short version Körner et al., 2008) at T1. Also, we included measures of self-esteem (Rosenberg Self Esteem Scale; Rosenberg, 1965), interpersonal problems (Inventory of Interpersonal Problems, German short version; Thomas et al., 2011), coping strategies (Coping Strategies Questionnaire; Verra et al., 2006) at T1, T2 and T3; T4, as well as patients’ subjective evaluation of the therapeutic working alliance (Working Alliance Inventory, revised German short version; Wilmers et al., 2008) at T3 (After Treatment). Additionally, we will ask patients to evaluate their overall experience with the therapeutic process (for example, their relationships with therapists and other patients during the program) with the German “Stationserfahrungsbogen” (Sammet and Schauenburg, 1999) at T3 (after Treatment). Part of the standard procedure is also the general assessment of psychological disorders based on the DSM-IV with the German structured clinical interview (Wittchen et al., 1997) at T1 (beginning of treatment).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/04/20
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

Our participants are enrolled as outpatients in the orthopedic clinic of the Heidelberg University Hospital and participate in a four-week multidisciplinary pain treatment including physiotherapy, ergotherapy, music and dance therapy, individual and group psychotherapy. As such, they
- have experienced chronic pain for at least six months
- are between 18 and 80 years of age
- have previously received standard treatment consisting of at least one rehabilitation program or two inpatient treatments or one pain treatment with a registered doctor, which did not yield lasting effects.

The participants of control group are
- between 18 - 65 years old
- understand the study and can answer the questions of the questionnaire independently
- written, signed consent

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Exclusion Criteria

- high CRP levels as an indicator of rheumatoid arthritis
- acute inflammations of the spine
- a tumor
- a diagnosed psychosis
- a diagnosis of a bipolar or neurological disorder
- an insufficient ability to communicate in German

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Addresses

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    • Schmerztherapie Tagesklinik Orthopädie Heidelberg
    • Mr.  Prof. Dr. med.  Marcus  Schiltenwolf 
    • Schlierbacher Landstraße 200a
    • 69118  Heidelberg
    • Germany
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    • Schmerztherapie Tagesklinik Orthopädie Heidelberg
    • Ms.  M.Sc.  Ann-Christin  Pfeifer 
    • Schlierbacher Landstr. 200a
    • 69118  Heidelberg
    • Germany
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    • Schmerztherapie Tagesklinik Orthopädie Heidelberg
    • Ms.  M.Sc.  Ann-Christin  Pfeifer 
    • Schlierbacher Landstr. 200a
    • 69118  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Stiftung Psychosomatik der Wirbelsäulenerkrankungen
    • Mr.  Dr.  Klaus  Kessler 
    • Königstraße 84
    • 70173  Stuttgart
    • Germany
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    • B. BRAUN-STIFTUNG
    • Ms.  M.A.  Nicole  Jacob 
    • Stadtwaldpark 10
    • 34212  Melsungen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/03/22
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Trial Publications, Results and other Documents

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