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

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.

Study Overview

• Status: Recruiting
• Conditions: Depressive Disorder

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.

• Study Type: Observational
• Enrollment (Estimated): 125

Contacts and Locations

• Study Contact: Name: Christian Mittermaier, M.D.; Phone Number: +43 (0)5 7680 83 - 6170; Email: Christian.Mittermaier@kepleruniklinikum.at

Study Locations

• Austria
  • Linz, Austria, 4020
    • Recruiting
    • Kepler University Clinic, Dept. of Physical Medicine & Rehabilitation
    • Contact: Christian Mittermaier, M.D.; Phone Number: +43 (0)5 7680 83 - 6170; Email: Christian.Mittermaier@kepleruniklinikum.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with depressive disorders; Patients with depressive disorders at the beginning and end of an inpatient stay

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Awareness Body Chart Questionnaire (ABC)	Body charts to fill in with colours according to intensity of body awareness. In sum, 51 body regions to colour with 5 different colour pencils (orange = "I can perceive with much detail", yellow = "I can perceive distinctly", green = "I can perceive", blue = "I can perceive indistinctly", black = "I cannot perceive"). To quantify the information, every region of the body will be coded as an extra item and the data of the colours will be transcribed: orange (= 5), yellow (= 4), green (= 3), blue (= 2), black (= 1). Higher values mean higher intensity of body awareness. In the case of pain, the pain location can also be marked on the body chart with a red pen and recorded on a 100 mm Visual Analogue Scale from 0 (no pain) to 100 (unbearable pain).	Within the first 7 days after admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Awareness Body Chart Questionnaire (ABC)	Body charts to fill in with colours according to intensity of body awareness. In sum, 51 body regions to colour with 5 different colour pencils (orange = "I can perceive with much detail", yellow = "I can perceive distinctly", green = "I can perceive", blue = "I can perceive indistinctly", black = "I cannot perceive"). To quantify the information, every region of the body will be coded as an extra item and the data of the colours will be transcribed: orange (= 5), yellow (= 4), green (= 3), blue (= 2), black (= 1). Higher values mean higher intensity of body awareness. In the case of pain, the pain location can also be marked on the body chart with a red pen and recorded on a 100 mm Visual Analogue Scale from 0 (no pain) to 100 (unbearable pain).	Before discharge
Like/Dislike Body Chart	As an extension to the ABC, this questionnaire is intended to answer the question of whether there are areas of the body that one particularly likes about oneself or that one dislikes about oneself. If yes, one can draw these with a purple color pencil ("particularly like") and/or with a gray color pencil ("do not like") in an extra Body Chart.	Within the first 7 days after admission and before discharge
Self-rating mood scale - revised	Verbal questionnaire concerning mood status. 24 pairs of oppositional adjectives concerning mood: One of them or <neither nor> should be ticked, depending on how it best corresponds to the current situation. The negative pole = 2. The positive pole = 0. <neither nor> = 1. Higher sum scores indicate worse subjective mood, lower values better mood.	Within the first 7 days after admission and before discharge
Beck Depression Inventory II (BDI-II)	The BDI-II represents a self-rating instrument to assess the severity of depression. Four statements are given for each of 21 questions, from which the one that best describes how the person has felt in the past week is to be selected. In scoring, each item is given a score of 0 to 3, depending on the choice (higher number means higher depression scores), and after directly adding the scores of the individual items, a total score of 0 to 63 is obtained. A score of 9-13 is considered minimal depression, 14-19 is mild depression, 20-28 is moderate depression, and scores above 29 indicate severe depression.	Within the first 7 days after admission and before discharge
Insomnia Severity Index (ISI)	The ISI is a self-assessment questionnaire used to evaluate the nature, severity, and impact of insomnia over the past two weeks. The ISI contains seven items rated with a five-point Likert scale (0 = not at all, 4 = very severe problem), with the total score ranging from 0 to 28. Higher scores indicate greater severity of insomnia. Scores from 0-7 are considered no insomnia, 8-14 is subthreshold insomnia, 15-21 is moderate insomnia, and 22-28 is severe insomnia.	Within the first 7 days after admission and before discharge
Simple Physical Activity Questionnaire (SIMPAQ)	Questionnaire to survey physical activity: It should show a snapshot of hours per day of an average day in the past week. The time in bed, the time while doing sedentary work (including dozing), while walking, while exercising and during other physical activities (such as household chores) is interrogated. The test does not measure the intensity of physical activity, but rather sorts it into the groups walking, sport and other categories.	Within the first 7 days after admission
Brief Symptom Inventory (BSI)	Questionnaire on the burden of symptoms. The BSI is also called the Brief Symptom Check List (BSCL), it is a short form of the SCL-90 (Derogatis, 1993). The BSI consists of 53 items (physical as well as psychological symptoms), which are assessed subjectively on a Likert scale in relation to the last seven days from 0 = "not at all" to 5 = "very strong". The items result in nine scales: somatization, obsession-compulsion, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation and psychoticism.	Within the first 7 days after admission
Demographic data and chronic complaints and current illnesses	Age, sex, height, weight, body mass index, and further demographic data. Chronic complaints and current illnesses.	Within the first 7 days after admission
Short Form 12 Health Survey (SF-12)	Questionnaire on health-related quality of life. It consists of twelve questions relating to the last four weeks and yields statements about eight different dimensions of subjective health: general health perception, physical health, physically-conditioned role function, physical pain, vitality, mental health, emotionally-related role function, social functionality. Different Likert-Scales are used. A physical sum scale and a psychological sum scale can be calculated. The polarity of four items must be reversed so that higher values in all items and total scales reflect a better state of health. Normative data are available. Values may range from 0-100, with a mean of 50 and a standard deviation of 10 in the general population. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.	Within the first 7 days after admission

Collaborators and Investigators

• Sponsor: Johannes Kepler University of Linz

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2025
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 11, 2025
• First Posted (Actual): March 17, 2025

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Depression; Body awareness
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: ABC-D_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No