DepressionNCT01136070
A Prospective Study of Body Image, Social Avoidance and Distress and Psychological Functioning in Burn Patients
An observational study of Depression and Anxiety, run by Saint Elizabeth Regional Medical Center at 1 site in United States.
Trial summary
The present study seeks to examine the course of body image, social avoidance and psychosocial aspects of depression and anxiety over time in burn patients. Gaining a better understanding of the effects of burn injury on body image in burn patients over time could help us to better understand the psychosocial sequelae… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Depression, Anxiety, Body Image
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Burn patients in community hospital with an estimated follow-up time of at least 3 months post-burn.
Who may be able to join
- Patients are admitted to the Saint Elizabeth Regional Medical Center Burn Unit.
- Age 19 and older.
- Patients have the cognitive and physical capacity to answer the questionnaires.
- Patients are expected to be seen at follow-up clinic visits or if they are still in the hospital within 2 weeks and at 3 months (+ or - 4 weeks)post-burn.
Who cannot join
- Patients are unable to return for follow up visits
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Elizabeth Regional Medical Center
Lincoln, Nebraska, 68510
About this study
The present study seeks to examine the course of body image, social avoidance and psychosocial aspects of depression and anxiety over time in burn patients. Gaining a better understanding of the effects of burn injury on body image in burn patients over time could help us to better understand the psychosocial sequelae of burns and to identify potential interventions which may serve to improve the quality of life in burn patients.
Read the detailed description
Gaining a better understanding of the effects of burn injury on body image in burn patients over time could help us to better understand the psychosocial sequelae of burns and to identify potential interventions which may serve to improve the quality of life in burn patients.
The original protocol has been modified to include more assessment times. The original protocol was set up to assess patients after patient discharge from the inpatient burn unit and at 6 and 12-months post discharge. The present protocol has been modified to capture assessments at 2 weeks, 3 months, 6 months, 9 months, 12 months post-burn. Patients will be assessed at these time points or until they are discharged from the outpatient burn clinic. In addition, inclusion criteria have been modified to include patients who are anticipated to have a follow-up visit to the burn outpatient clinic at 3 months post-burn. The original protocol required an anticipated follow-up for 12 months post-hospital discharge.
- Conditions
- Depression, Anxiety, Body Image
- Keywords
- Psychological Functioning in Burn Patients
- Medical subject headings
- Depression, Anxiety Disorders
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 |
|---|---|---|
| Burn Trauma Patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction With Appearance Scale
Measured: 2 weeks post-burn
Brief Symptom Inventory
Measured: 2 weeks post-burn
Satisfaction with Appearance Scale
Measured: 3 months post-burn
Satisfaction with Appearance Scale
Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.
Measured: 6 months post-burn
Satisfaction with Appearance Scale
Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.
Measured: 9 months post-burn
Satisfaction with Appearance Scale
Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.
Measured: 12 months post-burn
Brief Symptom Inventory
Measured: 3 months post-burn
Brief Symptom Inventory
Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.
Measured: 6 months post-burn
Brief Symptom Inventory
Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.
Measured: 9 months post-burn
Brief Symptom Inventory
Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.
Measured: 12 months post-burn
Secondary outcomes (5)
The Social Avoidance and Distress Scale
Measured: 2 weeks post-burn
The Social Avoidance and Distress Scale
Measured: 3 months post-burn
The Social Avoidance and Distress Scale
Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.
Measured: 6 moths post-burn
The Social Avoidance and Distress Scale
Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.
Measured: 9 months post-burn
The Social Avoidance and Distress Scale
Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.
Measured: 12 months post-burn
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Elizabeth Regional Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- David W. Voigt, MD, Principal investigator, Saint Elizabeth Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01136070
- Sponsor's protocol ID
- 609-053
- Status last verified
- Oct 2016
- First submitted
- 26 May 2010
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Body Image, Social Avoidance and Distress and Psychological Functioning in Burn Patients
- ClinicalTrials.gov ID
- NCT01136070
- Acronym / sponsor ID
- 609-053
- Conditions
- Depression, Anxiety, Body Image
- Keywords
- Psychological Functioning in Burn Patients
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Saint Elizabeth Regional Medical CenterUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 3 Jun 2010 (estimated)
- 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.
The present study seeks to examine the course of body image, social avoidance and psychosocial aspects of depression and anxiety over time in burn patients. Gaining a better understanding of the effects of burn injury on body image in burn patients over time could help us to better understand the psychosocial sequelae of burns and to identify potential interventions which may serve to improve the quality of life in burn patients.
Detailed description
Gaining a better understanding of the effects of burn injury on body image in burn patients over time could help us to better understand the psychosocial sequelae of burns and to identify potential interventions which may serve to improve the quality of life in burn patients.
The original protocol has been modified to include more assessment times. The original protocol was set up to assess patients after patient discharge from the inpatient burn unit and at 6 and 12-months post discharge. The present protocol has been modified to capture assessments at 2 weeks, 3 months, 6 months, 9 months, 12 months post-burn. Patients will be assessed at these time points or until they are discharged from the outpatient burn clinic. In addition, inclusion criteria have been modified to include patients who are anticipated to have a follow-up visit to the burn outpatient clinic at 3 months post-burn. The original protocol required an anticipated follow-up for 12 months post-hospital discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Burn Trauma Patients | – | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Burn patients in community hospital with an estimated follow-up time of at least 3 months post-burn.
Key inclusion criteria (4 listed)
- Patients are admitted to the Saint Elizabeth Regional Medical Center Burn Unit.
- Age 19 and older.
- Patients have the cognitive and physical capacity to answer the questionnaires.
- Patients are expected to be seen at follow-up clinic visits or if they are still in the hospital within 2 weeks and at 3 months (+ or - 4 weeks)post-burn.
Key exclusion criteria (1 listed)
- Patients are unable to return for follow up visits
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
Satisfaction With Appearance Scale
Time frame: 2 weeks post-burn
Brief Symptom Inventory
Time frame: 2 weeks post-burn
Satisfaction with Appearance Scale
Time frame: 3 months post-burn
Satisfaction with Appearance Scale
Time frame: 6 months post-burn
Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.
Satisfaction with Appearance Scale
Time frame: 9 months post-burn
Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.
Satisfaction with Appearance Scale
Time frame: 12 months post-burn
Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.
Brief Symptom Inventory
Time frame: 3 months post-burn
Brief Symptom Inventory
Time frame: 6 months post-burn
Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.
Brief Symptom Inventory
Time frame: 9 months post-burn
Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.
Brief Symptom Inventory
Time frame: 12 months post-burn
Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.
5 secondary outcomes
The Social Avoidance and Distress Scale
Time frame: 2 weeks post-burn
The Social Avoidance and Distress Scale
Time frame: 3 months post-burn
The Social Avoidance and Distress Scale
Time frame: 6 moths post-burn
The Social Avoidance and Distress Scale
Time frame: 9 months post-burn
The Social Avoidance and Distress Scale
Time frame: 12 months post-burn
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
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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. This study is not recruiting at the moment.
David W. Voigt, MD principal investigator
Saint Elizabeth Regional Medical Center
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 Depression and Anxiety, run by Saint Elizabeth Regional Medical Center at 1 site in United States.
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 4 inclusion and 1 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: withdrawn, as of the sponsor's last update on 13 Oct 2016. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction With Appearance Scale (time frame: 2 weeks post-burn). The study lists 10 primary outcomes in all. 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 13 Oct 2016.