A combined pain competence and depression prevention training in inpatient multidisciplinary rehabilitation for chronic low back pain (Debora I)

A combined pain competence and depression prevention training in inpatient multidisciplinary rehabilitation for chronic low back pain (Debora I) - Debora I

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

DRKS

Registry ID

DRKS00015465

Enrollment

1173

Registered

2018-09-03

Start date

2014-10-06

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M51 M54 M53

Interventions

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,

Eligibility

Sex/Gender

All

Age

20 Years to 65 Years

Inclusion criteria

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

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).

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Secondary

Measure	Time frame
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).	—

Countries

Germany

Contacts

Public ContactPetra Hampel

Europa-Universität Flensburg

petra.hampel@uni-flensburg.de04618052418

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 4, 2026