NCT06879977

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 17, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

March 26, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 8, 2025

Status Verified

March 1, 2025

Enrollment Period

5 months

First QC Date

March 11, 2025

Last Update Submit

April 3, 2025

Conditions

Keywords

DepressionBody awareness

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Awareness Body Chart Questionnaire (ABC)

    Before discharge

  • Like/Dislike Body Chart

    Within the first 7 days after admission and before discharge

  • Self-rating mood scale - revised

    Within the first 7 days after admission and before discharge

  • Beck Depression Inventory II (BDI-II)

    Within the first 7 days after admission and before discharge

  • Insomnia Severity Index (ISI)

    Within the first 7 days after admission and before discharge

  • +4 more secondary outcomes

Study Arms (1)

Patients with depressive disorders

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

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kepler University Clinic, Dept. of Physical Medicine & Rehabilitation

Linz, 4020, Austria

RECRUITING

MeSH Terms

Conditions

Depressive DisorderDepression

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersBehavioral SymptomsBehavior

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department, M.D.

Study Record Dates

First Submitted

March 11, 2025

First Posted

March 17, 2025

Study Start

March 26, 2025

Primary Completion

September 1, 2025

Study Completion

December 1, 2025

Last Updated

April 8, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations