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Body Awareness in People With Depressive Disorder (ABC-D)

J

Johannes Kepler University of Linz

Status

Enrolling

Conditions

Depressive Disorder

Study type

Observational

Funder types

Other

Identifiers

NCT06879977
ABC-D_1

Details and patient eligibility

About

Body awareness plays a crucial role in health and well-being. However, too little research has been carried out on how it manifests in individuals with depressive disorders. The Awareness Body Chart (ABC), a tool developed in recent years to assess body awareness, may provide new insights into the physical experience of people with depression and may lead the way in the application of body-oriented therapies in this cohort. Information about the distribution properties of the Awareness Body Chart in people with depressive disorder will be collected and analysed in this observational study.

Full description

Research Questions:

  • Primary Research Question What are the distribution properties of the body awareness assessed by the ABC?

  • Secondary Research Questions (exploratory)

    1. Which factors (demographic, physical, psychological) correlate with body awareness?
    2. Does body awareness and mood change during an inpatient stay? Method: Observational Study Participants: 125 patients with depressive disorders at the beginning and end of an inpatient stay.

Assessments via Questionnaires:

Completion of questionnaires (partially with assistance) within the first 7 days after admission:

  • Demographic data and questions about health/relevant pre-existing conditions, including body weight and height, i.e. Body Mass Index
  • Awareness Body Chart (ABC)
  • Like/Dislike Body Chart (L/D-BC)
  • Self-Rating Mood Scale-Revised (Bf-SR)
  • Simple Physical Activity Questionnaire (SIMPAQ)
  • Short Form Health Survey (SF-12)
  • Brief Symptom Inventory (BSI)
  • Beck Depression Inventory II (BDI-II)
  • Insomnia Severity Index (ISI)

Pre-Discharge Questionnaire Completion:

  • ABC
  • L/D-BC
  • Bf-SR
  • BDI-II
  • ISI

Statistical Analysis:

For the analysis of the primary outcome, the ABC score for the entire sample will be presented using the mean and standard deviation or median and interquartile range, depending on the distribution properties of the ABC score. For the analysis of secondary questions, the total scores of the ABC and factor scores will be compared between men and women, between patients with and without pain, using t-tests or Mann-Whitney U-tests, and between individuals with different categories of depressive disorders or varying severities of depression using ANOVA or Kruskal-Wallis tests.

Furthermore, the correlation of body awareness with demographic data, body mass index, diagnosis group, disease duration, test results from SIMPAQ, SF-12, BSI, Bf-SR, and ISI will be investigated using correlation analyses, where the correlation coefficient will be calculated either using Pearson or Spearman, depending on the distribution of the data. Changes in body awareness and well-being during an inpatient stay will be analyzed using paired t-tests or Wilcoxon signed-rank tests.

Outlook:

The study serves as a basis for further research on body awareness in individuals with depressive disorders.

Enrollment

125 estimated patients

Sex

All

Ages

18 to 69 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age 18 - 69 years
  • Medical diagnosis of a depressive disorder, including depressive adjustment disorder and depressive episodes in the context of bipolar disorder, i.e. one of the following ICD-10 codes:
  • F32 Depressive Episode
  • F33 Recurrent Depressive Disorder
  • F31.3 Bipolar Affective Disorder, current mild or moderate depressive episode
  • F31.4 Bipolar Affective Disorder, current severe depressive episode without psychotic symptoms
  • F43.20 Adjustment Disorder with Brief Depressive Reaction
  • F43.21 Adjustment Disorder with Prolonged Depressive Reaction
  • Inpatient admission
  • Written informed consent

Exclusion criteria

  • Inability to fill out questionnaires with or without assistance due to language, physical, or cognitive limitations
  • Acute psychotic state
  • Known body schema disorders, e.g. due to significant neurological or malignant diseases, eating disorders, congenital or acquired physical limitations such as the absence of a body part
  • Deafness, blindness

Trial design

125 participants in 1 patient group

Patients with depressive disorders
Description:
Patients with depressive disorders at the beginning and end of an inpatient stay

Trial contacts and locations

1

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Central trial contact

Christian Mittermaier, M.D.

Data sourced from clinicaltrials.gov

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