Depressive DisorderABC-DNCT06879977
Body Awareness in People With Depressive Disorder
An observational study of Depressive Disorder, run by Johannes Kepler University of Linz at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Depressive Disorder
- How many people
- 125 participants
- Where
- 1 siteAustria
- Study dates
- 26 Mar 2025to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with depressive disorders at the beginning and end of an inpatient stay.
Who may be able to join
- 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
Show all 10Show fewer
- F43.20 Adjustment Disorder with Brief Depressive Reaction
- F43.21 Adjustment Disorder with Prolonged Depressive Reaction
- Inpatient admission
- Written informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Christian Mittermaier, M.D. contact
Austria1 site, 1 recruiting
- Recruiting
Kepler University Clinic, Dept. of Physical Medicine & Rehabilitation
Linz, 4020
Christian Mittermaier, M.D., +43 (0)5 7680 83 - 6170, Christian.Mittermaier@kepleruniklinikum.at
About this study
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.
Read the detailed description
Research Questions:
- Primary Research Question What are the distribution properties of the body awareness assessed by the ABC?
- Secondary Research Questions (exploratory)
- Which factors (demographic, physical, psychological) correlate with body awareness?
- 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.
- Conditions
- Depressive Disorder
- Keywords
- Depression, Body awareness
- Medical subject headings
- Depressive Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with depressive disorders | Patients with depressive disorders at the beginning and end of an inpatient stay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Within the first 7 days after admission
Secondary outcomes (9)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within the first 7 days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start26 Mar 2025
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Kepler University of Linz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Mittermaier, Johannes Kepler University of Linz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879977
- Sponsor's protocol ID
- ABC-D_1
- Acronym
- ABC-D
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Awareness in People With Depressive Disorder
- ClinicalTrials.gov ID
- NCT06879977
- Acronym / sponsor ID
- ABC-D / ABC-D_1
- Conditions
- Depressive Disorder
- Keywords
- Depression, Body awareness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Johannes Kepler University of LinzUniversity, hospital or other
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
- Which factors (demographic, physical, psychological) correlate with body awareness?
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with depressive disorders | – | –Patients with depressive disorders at the beginning and end of an inpatient stay |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with depressive disorders at the beginning and end of an inpatient stay.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Awareness Body Chart Questionnaire (ABC)
Time frame: Within the first 7 days after admission
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).
9 secondary outcomes
Awareness Body Chart Questionnaire (ABC)
Time frame: Before discharge
Like/Dislike Body Chart
Time frame: Within the first 7 days after admission and before discharge
Self-rating mood scale - revised
Time frame: Within the first 7 days after admission and before discharge
Beck Depression Inventory II (BDI-II)
Time frame: Within the first 7 days after admission and before discharge
Insomnia Severity Index (ISI)
Time frame: Within the first 7 days after admission and before discharge
Simple Physical Activity Questionnaire (SIMPAQ)
Time frame: Within the first 7 days after admission
Short Form 12 Health Survey (SF-12)
Time frame: Within the first 7 days after admission
Brief Symptom Inventory (BSI)
Time frame: Within the first 7 days after admission
Demographic data and chronic complaints and current illnesses
Time frame: Within the first 7 days after admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christian Mittermaier, M.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Disorder, run by Johannes Kepler University of Linz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian Mittermaier, M.D. (+43 (0)5 7680 83 - 6170, Christian.Mittermaier@kepleruniklinikum.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Awareness Body Chart Questionnaire (ABC) (time frame: Within the first 7 days after admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.