Anorexia NervosaNCT00766558
The Effects of Written Emotional Disclosure on Eating Disorder Pathology in a Clinical Eating Disordered Population
An observational study of Anorexia Nervosa and Bulimia Nervosa, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
A technique that has been found to be effective at relieving the physical and psychological symptoms associated with inhibiting emotions and emotional thoughts is written emotional disclosure. Read more about this study
- Who is it for?
- Ages 14 to 50 years
- Conditions the study is for
- Anorexia Nervosa, Bulimia Nervosa, Eating Disorder
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jul 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 14 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients in the Penn State Hershey Adolescentand Adult Eating Disorders Partial Hospitalization Program
Who may be able to join
- Willing to sign consent form
Who cannot join
- Unwilling to sign consent form
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State College of Medicine
Hershey, Pennsylvania, 17033
About this study
Official title: Study of the Efficacy of Written Emotional Disclosure on Eating Disorder Pathology
A technique that has been found to be effective at relieving the physical and psychological symptoms associated with inhibiting emotions and emotional thoughts is written emotional disclosure. The goal of this study is to evaluate the effectiveness of written emotional disclosure on the remediation of eating disorder behaviour, cognitions, and management of emotions.
Read the detailed description
New Partial program participants complete a packet of questionnaires during their initial appointment, which will be used as baseline levels of eating disorder symptoms and psychological health. Participants will complete the writing as part of their eating disorder therapy. The writing will be completed individually. The writing will consist of continuous writing for fifteen minutes on three consecutive days. The experimental group will write about traumatic or stressful experiences, while the control group will objectively describe events. A post-writing packet of questionnaires will be completed one week after completing the writing. A follow-up evaluation will occur four-weeks after completion of the post-writing packet and will include completing a packet of questionnaires and debriefing.
- Conditions
- Anorexia Nervosa, Bulimia Nervosa, Eating Disorder
- Keywords
- anorexia, bulimia, eating disorder not otherwise specified
- Medical subject headings
- Anorexia Nervosa, Bulimia Nervosa, Feeding and Eating Disorders, Anorexia, Bulimia
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 |
|---|---|---|
| 1 Disclosure | Traumatic writing prompts provided. Participant is assigned a potential stress-producing topic for written disclosure. | |
| 2 control | Received nontraumatic writing prompts. Participant assigned a non-stressful writing condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Testing and behavioral changes
Measured: 6-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2008 (estimated)
- Study startJun 2009
- Primary completionJun 2010
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard L Levine, MD, Principal investigator, Penn State College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00766558
- Sponsor's protocol ID
- 28860
- Status last verified
- Jun 2017
- First submitted
- 3 Oct 2008
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pennebaker, J. W., Chung, C. K., Ireland, M., Gonzales, A., and Booth, R. J. (2007). The development and psychometric properties of LIWC2007. Retrieved June 1, 2008, from Linguistic Inquiry and Word Count web site http://www.LIWC.net/liwcdescription.php
Pennebaker, J. W. and Francis, M. E. (1996). Cognitive, emotional, and language processes in disclosure. Cognition and Emotion, 10, 601-626.
Pennebaker JW, Kiecolt-Glaser JK, Glaser R. Disclosure of traumas and immune function: health implications for psychotherapy. J Consult Clin Psychol. 1988 Apr;56(2):239-45. doi: 10.1037//0022-006x.56.2.239. No abstract available.
PubMed 3372832Petrie KJ, Booth RJ, Pennebaker JW. The immunological effects of thought suppression. J Pers Soc Psychol. 1998 Nov;75(5):1264-72. doi: 10.1037//0022-3514.75.5.1264.
PubMed 9866186Petrie KJ, Fontanilla I, Thomas MG, Booth RJ, Pennebaker JW. Effect of written emotional expression on immune function in patients with human immunodeficiency virus infection: a randomized trial. Psychosom Med. 2004 Mar-Apr;66(2):272-5. doi: 10.1097/01.psy.0000116782.49850.d3.
PubMed 15039514Quinton, S. and Wagner, H. L. (2005). Emotional expression, alexithymia, and characteristics associated with eating psychopathology in non-clinical women. Personality and Individual Differences, 38, 1163-1173.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Efficacy of Written Emotional Disclosure on Eating Disorder Pathology
- ClinicalTrials.gov ID
- NCT00766558
- Acronym / sponsor ID
- 28860
- Conditions
- Anorexia Nervosa, Bulimia Nervosa, Eating Disorder
- Keywords
- anorexia, bulimia, eating disorder not otherwise specified
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 6 Oct 2008 (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.
A technique that has been found to be effective at relieving the physical and psychological symptoms associated with inhibiting emotions and emotional thoughts is written emotional disclosure. The goal of this study is to evaluate the effectiveness of written emotional disclosure on the remediation of eating disorder behaviour, cognitions, and management of emotions.
Detailed description
New Partial program participants complete a packet of questionnaires during their initial appointment, which will be used as baseline levels of eating disorder symptoms and psychological health. Participants will complete the writing as part of their eating disorder therapy. The writing will be completed individually. The writing will consist of continuous writing for fifteen minutes on three consecutive days. The experimental group will write about traumatic or stressful experiences, while the control group will objectively describe events. A post-writing packet of questionnaires will be completed one week after completing the writing. A follow-up evaluation will occur four-weeks after completion of the post-writing packet and will include completing a packet of questionnaires and debriefing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Disclosure | – | –Traumatic writing prompts provided. Participant is assigned a potential stress-producing topic for written disclosure. |
| 2 control | – | –Received nontraumatic writing prompts. Participant assigned a non-stressful writing condition |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients in the Penn State Hershey Adolescentand Adult Eating Disorders Partial Hospitalization Program
Key inclusion criteria (1 listed)
- Willing to sign consent form
Key exclusion criteria (1 listed)
- Unwilling to sign consent form
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
Testing and behavioral changes
Time frame: 6-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- BackgroundPennebaker, J. W., Chung, C. K., Ireland, M., Gonzales, A., and Booth, R. J. (2007). The development and psychometric properties of LIWC2007. Retrieved June 1, 2008, from Linguistic Inquiry and Word Count web site http://www.LIWC.net/liwcdescription.php
- BackgroundPennebaker, J. W. and Francis, M. E. (1996). Cognitive, emotional, and language processes in disclosure. Cognition and Emotion, 10, 601-626.
- Background: PubMed 3372832Pennebaker JW, Kiecolt-Glaser JK, Glaser R. Disclosure of traumas and immune function: health implications for psychotherapy. J Consult Clin Psychol. 1988 Apr;56(2):239-45. doi: 10.1037//0022-006x.56.2.239. No abstract available.
- Background: PubMed 9866186Petrie KJ, Booth RJ, Pennebaker JW. The immunological effects of thought suppression. J Pers Soc Psychol. 1998 Nov;75(5):1264-72. doi: 10.1037//0022-3514.75.5.1264.
- Background: PubMed 15039514Petrie KJ, Fontanilla I, Thomas MG, Booth RJ, Pennebaker JW. Effect of written emotional expression on immune function in patients with human immunodeficiency virus infection: a randomized trial. Psychosom Med. 2004 Mar-Apr;66(2):272-5. doi: 10.1097/01.psy.0000116782.49850.d3.
- BackgroundQuinton, S. and Wagner, H. L. (2005). Emotional expression, alexithymia, and characteristics associated with eating psychopathology in non-clinical women. Personality and Individual Differences, 38, 1163-1173.
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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.
Richard L Levine, MD principal investigator
Penn State College of Medicine
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 Anorexia Nervosa and Bulimia Nervosa, run by Milton S. Hershey 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 1 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: finished, as of the sponsor's last update on 20 Jun 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Testing and behavioral changes (time frame: 6-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00766558, which also lists 6 linked publications.
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 20 Jun 2017.