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Clinical Trials/NCT06879977
NCT06879977RecruitingNot Applicable

Body Awareness in People With Depressive Disorder

Johannes Kepler University of Linz1 site in 1 country125 target enrollmentStarted: March 26, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
125
Locations
1
Primary Endpoint
Awareness Body Chart Questionnaire (ABC)

Study Overview

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:

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 69 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • Demographic data and chronic complaints and current illnesses(Within the first 7 days after admission)
  • Like/Dislike Body Chart(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)
  • Short Form 12 Health Survey (SF-12)(Within the first 7 days after admission)
  • Brief Symptom Inventory (BSI)(Within the first 7 days after admission)
  • Awareness Body Chart Questionnaire (ABC)(Before discharge)
  • Self-rating mood scale - revised(Within the first 7 days after admission and before discharge)
  • Insomnia Severity Index (ISI)(Within the first 7 days after admission and before discharge)
  • Simple Physical Activity Questionnaire (SIMPAQ)(Within the first 7 days after admission)

Investigators

Sponsor
Johannes Kepler University of Linz
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Christian Mittermaier

Head of Department, M.D.

Johannes Kepler University of Linz

Study Sites (1)

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