Clinical trial NCT06879977: Body Awareness in People With Depressive Disorder
Official title: Body Awareness in People With Depressive Disorder
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Depressive Disorder
Keywords: Depression
Body awareness
Lead sponsor: Johannes Kepler University of Linz
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with depressive disorders at the beginning and end of an inpatient stay.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Awareness Body Chart Questionnaire (ABC)
timeFrame: Within the first 7 days after admission
Secondary outcomes:
measure: Awareness Body Chart Questionnaire (ABC)
timeFrame: Before discharge
measure: Like/Dislike Body Chart
timeFrame: Within the first 7 days after admission and before discharge
measure: Self-rating mood scale - revised
timeFrame: Within the first 7 days after admission and before discharge
measure: Beck Depression Inventory II (BDI-II)
timeFrame: Within the first 7 days after admission and before discharge
measure: Insomnia Severity Index (ISI)
timeFrame: Within the first 7 days after admission and before discharge
measure: Simple Physical Activity Questionnaire (SIMPAQ)
timeFrame: Within the first 7 days after admission
measure: Short Form 12 Health Survey (SF-12)
timeFrame: Within the first 7 days after admission
measure: Brief Symptom Inventory (BSI)
timeFrame: Within the first 7 days after admission
measure: Demographic data and chronic complaints and current illnesses
timeFrame: Within the first 7 days after admission
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Kepler University Clinic, Dept. of Physical Medicine & Rehabilitation
Study officials:
References: