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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00015465 |
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Date of registration:
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03/09/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A combined pain competence and depression prevention training in inpatient multidisciplinary rehabilitation for chronic low back pain (Debora I)
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Scientific title:
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A combined pain competence and depression prevention training in inpatient multidisciplinary rehabilitation for chronic low back pain (Debora I) - Debora I |
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Date of first enrolment:
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06/10/2014 |
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Target sample size:
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1173 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00015465 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: prevention
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Phase:
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2
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Countries of recruitment
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Germany
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Contacts
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Name:
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Steffen
Ohmann |
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Address:
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Postfach
10704
Berlin
Germany |
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Telephone:
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03086582613 |
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Email:
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steffen.ohmann@drv-bund.de |
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Affiliation:
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Deutsche Rentenversicherung Bund |
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Name:
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Petra
Hampel |
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Address:
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Auf dem Campus 1
24943
Flensburg
Germany |
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Telephone:
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04618052418 |
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Email:
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petra.hampel@uni-flensburg.de |
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Affiliation:
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Europa-Universität Flensburg |
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Key inclusion & exclusion criteria
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Inclusion criteria: A diagnosis of CLBP lasting at least 6 months (ICD-10: M51, M53, M54), informed consent for participation, and German language skills.
Exclusion criteria: Patients were excluded if they underwent surgery or had an accident in the last 6 months before rehabilitation, had somatic diseases inducing back pain (radicular symptoms, tumors, osteoporosis, inflammation, fibromyalgia), were pregnant, had infections, had cardiovascular or metabolic diseases affecting rehabilitation, or had a serious psychiatric disorder (severe anxiety disorder, depression, or psychotic symptoms, posttraumatic stress disorder).
Age minimum:
20 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Other intervertebral disc disorders
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Dorsalgia
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Other dorsopathies, not elsewhere classified
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M51
M54
M53
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Intervention(s)
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Group 1: Control group: consisted of 75-minute group interventions guided by a psychotherapist and a 25-minute group workshop without a psychotherapist and dealt with behavioral patterns, cognitions, emotions, and stress and their relation to pain (see also Mohr et al., 2017).
Group 2: Intervention group: also received pain competence training and additionally a cognitive-behavioral depression prevention training, which included another four 75-minute sessions followed by a 25-minute workshop without a psychotherapist. The treatment elements were Activity Management, Pain Communication and Emotions, Cognitive Restructuring and Stress Management. The depression prevention training built on the contents of pain competence training and deepened it.
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Primary Outcome(s)
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To assess the primary outcome and the secondary outcome measures as well as the sociodemographic parameters, standardized questionnaires were used at the beginning of rehabilitation (t0), immediate after rehabilitation (t1), 6 (t2), 12 (t3) and 24 months after rehabilitation (t4).
Primary target size:
- Depression (German version of the Center for Epidemiological Studies Depression Scale (CES-D)
- anxiety (anxiety scale of the Hospital Anxiety and Depression Scale; HADS)
- Somatization (Brief Symptom Inventory; BSI-18)
- Symptoms of anxiety and depression in addition with Patient Health Questionnaire (PHQ-4)
- Short version of the short-form health survey (SF-12)
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Secondary Outcome(s)
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Other essential parameters relate inter alia. on:
- Pain-related parameters (e.g., DGSS pain questionnaire),
- pain-related self-efficacy (FESS)
- pain coping (FESV-BW),
- pain cognitions (AEQ),
- General and occupational-related strain (TICS and SPE)
- Subjective work ability (WAI).
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Source(s) of Monetary Support
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Deutsche Rentenversicherung Bund
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Ethics review
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Status: Approved
Approval date: 19/09/2013
Contact:
Ethikkommission der Deutschen Gesellschaft für Psychologie Ethik-Kommission DG Psychologie - Universität Trier [Ethikkommission der Deutschen Gesellschaft für Psychologie Ethik-Kommission DGPsychologie - Universität Trier
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