Anorexia NervosaANAPRNCT03712384
Severe Anorexia Nervosa Personal Recovery
An observational study of Anorexia Nervosa and Eating Disorder, run by Institut Mutualiste Montsouris at 1 site in France.
Trial summary
A growing qualitative literature about personal recovery process in mental disorders emerges. However in Anorexia Nervosa (AN), it remains few understood, especially in severe AN during adolescence. Read more about this study
- Who is it for?
- Ages 20 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa, Eating Disorder
- What is being tested?
- Semi structured face to face interview
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jun 2014to 5 Jul 2014
- 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 20 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Young people who suffered of severe AN and experienced hospitalization during adolescence feels recovered
Who may be able to join
- woman
- Adult between 20 and 30 years old
- With history of restrictive AN (CIM 10: F50)
- Without no other comorbidity
- Hospitalized for AN during adolescence (10-19 years old) ten years ago, in adolescent psychiatry at Institute Mutualiste Montsouris (France)
- Native French speaker
- Considers herself recovered
- Agreement
Who cannot join
- Presence of AN criteria (ICD-10: F50) during research interview,
- Absence of all recovery qualitative criteria after qualitative analysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personal Recovery of Young Adults With Severe Anorexia Nervosa During Adolescence: a Pilot Qualitative Study
A growing qualitative literature about personal recovery process in mental disorders emerges. However in Anorexia Nervosa (AN), it remains few understood, especially in severe AN during adolescence.
This pilot study seeks to enhance understanding of recovery from AN in France and support the dissemination of the PR paradigm among the French mental health community working with AN, as a complement to the medical approach.
A qualitative research according to Interpretative Phenomenological Analysis (IPA) method was conducted .Five young women hospitalized ten years before for a severe AN during their adolescence were interviewed with a semi-structured face-to-face interview on recovery process.
Read the detailed description
Anorexia Nervosa (AN) is one of the most severe mental disorders with a mortality and high risk of developing chronicity. Lifetime prevalence is evaluated among women between 1.2% and 2.2%, with the higher incidence during adolescence. Recovery process remains poorly understood.
In scientific literature, recovery process of mental disorders can be seen in two different ways: the medical and the personal recovery (PR). The medical recovery is based on objective criteria, including cure (symptom disappearance), remission (symptom suspension) or therapeutic response (change of values after treatment). This medical recovery is generally studied in quantitative outcome studies. The experiential or PR is based on first person qualitative research or consensus methods, starting from patients' struggle for regaining place in their own recovery. It has become the paradigm orientation of mental health policy in anglophone countries.
A recent systematic review summeries relapse, remission or recovery criteria used in a AN outcome studies in 1-weigh measurement only; 2-symptoms reported only; 3-on both. In addition to weigh, other criteria are noticed: menstruations, psychological and behavioral features, disparities of time remission/recovery.
However, despite numerous quantitative studies, reasons for recovery, relapse or following struggle steal unclear. Medical framework is sometimes considered as reductive Moreover, those researches usually focus on risk factors, hiding protector's factors that are central for supporting recovery. Furthermore, symptom improvement is not always priority of patients(9), while improvement might happen despite symptoms persistence. Discrepancies are described in the negotiated link clinicians-patients: patient might wait for more singular and subjective approach whereas clinicians would be more invested in objective and rigorous features.
A recent systematic review offers a theorical framework to study PR in mental disorders. It is defines as an active, individual, unique, non-linearn, multidimensional and gradual process. It can be described as phase or stage, as struggle, as a life-changing experience or even as a trial or error process. It may be structured by a turning point, after when there are no turning back. It is aided by supporting and healing environment, and might occur without cure. Starting from first person narratives of mental disorders recovery, five factors supporting recovery are described: connectedness, hope and optimism about the future, identity, meaning in life, empowerment. One meta-ethnography review was published on qualitative research about PR in AN, concerning 8 studies. It provides elements on process of change, factors supporting PR and notion of empowerment and self-reconciliation.
Finally, most of PR studies come from USA, UK, Australia and Canada. Further research are needed to ground PR including cultural context. In France, AN PR has been rarely studied. These study tries to enhance understanding AN recovery in French context, to support implementation of PR paradigm among French mental health AN community; complementary to medical approach.
Study questions are: how people who suffered of severe AN and experienced hospitalization during adolescence feel and make sense to their recovery?
METHODS This study is a qualitative research with IPA, supplemented by quotation of ICD 10 criteria. We reported COREQ 32 guidelines.
Setting and participants IPA recommends homogeneous and short sampling so as to better appreciate convergences and divergences of phenomena. To maximize homogenization, very precise criteria (presented in box 1) were first chosen in order to focus on studied phenomena with in-depth way, before opening to wider study on AN recovery. Recruitment was restrained to the same hospital (Institut Mutualiste Montsouris) at the same year of hospitalization, so as to homogenize experience of care. Period of 10 years was chosen for being widely beyond largest literature mean criteria of medical recovery fixed at seven years, to get some distance with recovery process.
- Conditions
- Anorexia Nervosa, Eating Disorder
- Being tested
- Semi structured face to face interview
- Keywords
- Recovery, Qualitative research, Personal narratives
- Medical subject headings
- Anorexia Nervosa, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi structured face to face interviewOther
Face-to-face semi-structured interview conducted in the hospital, where young adults were hospitalized 10 years before, in a quiet and isolated office. The topic guide was built according to literature review, without further change after pilot test. Interviews where audio-recorded and transcribed
| Study group | Role | What they receive |
|---|---|---|
| Young adult with severe anorexia | Young adult with severe Anorexia hospitalized during adolescence at Institut Mutualiste Montsouris Receives: Other: Semi structured face to face interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery process of AN
Initial interview topic guide domain
- How have you spent your life for the first hospitalization for AN?
- What are the factors that help or prevent from going ahead?
- All this way long, how did feel talking about yourself?
- How did evolve your relationships?
- How have you felt your body all this way long?
- How do you define recovery of AN during adolescence?
- How would you define yourself?
- What kind of stories do you tell yourself about AN?
- If you would be faced with someone with current AN, what would you advice him/her?
Measured: Semi structured face to face interview, 10 years after hospitalization for AN.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start20 Jun 2014
- Primary completion5 Jul 2014
- Study completion5 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies 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
- Retrospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Mutualiste Montsouris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Aude PIOT, Principal investigator, Institut Mutualiste Montsouris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712384
- Sponsor's protocol ID
- PSY-2014-04
- Acronym
- ANAPR
- Status last verified
- Feb 2019
- First submitted
- 15 Oct 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khalsa SS, Portnoff LC, McCurdy-McKinnon D, Feusner JD. What happens after treatment? A systematic review of relapse, remission, and recovery in anorexia nervosa. J Eat Disord. 2017 Jun 14;5:20. doi: 10.1186/s40337-017-0145-3. eCollection 2017.
PubMed 28630708Arcelus J, Mitchell AJ, Wales J, Nielsen S. Mortality rates in patients with anorexia nervosa and other eating disorders. A meta-analysis of 36 studies. Arch Gen Psychiatry. 2011 Jul;68(7):724-31. doi: 10.1001/archgenpsychiatry.2011.74.
PubMed 21727255Strober M, Freeman R, Morrell W. The long-term course of severe anorexia nervosa in adolescents: survival analysis of recovery, relapse, and outcome predictors over 10-15 years in a prospective study. Int J Eat Disord. 1997 Dec;22(4):339-60. doi: 10.1002/(sici)1098-108x(199712)22:43.0.co;2-n.
PubMed 9356884Leamy M, Bird V, Le Boutillier C, Williams J, Slade M. Conceptual framework for personal recovery in mental health: systematic review and narrative synthesis. Br J Psychiatry. 2011 Dec;199(6):445-52. doi: 10.1192/bjp.bp.110.083733.
PubMed 22130746Wollburg E, Meyer B, Osen B, Lowe B. Psychological change mechanisms in anorexia nervosa treatments: how much do we know? J Clin Psychol. 2013 Jul;69(7):762-73. doi: 10.1002/jclp.21945. Epub 2013 Jan 24.
PubMed 23349069Espindola CR, Blay SL. Anorexia nervosa's meaning to patients: a qualitative synthesis. Psychopathology. 2009;42(2):69-80. doi: 10.1159/000203339. Epub 2009 Feb 19.
PubMed 19225241Noordenbos G, Seubring A. Criteria for recovery from eating disorders according to patients and therapists. Eat Disord. 2006 Jan-Feb;14(1):41-54. doi: 10.1080/10640260500296756.
PubMed 16757448Westwood LM, Kendal SE. Adolescent client views towards the treatment of anorexia nervosa: a review of the literature. J Psychiatr Ment Health Nurs. 2012 Aug;19(6):500-8. doi: 10.1111/j.1365-2850.2011.01819.x. Epub 2011 Sep 27.
PubMed 22070426Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007 Dec;19(6):349-57. doi: 10.1093/intqhc/mzm042. Epub 2007 Sep 14.
PubMed 17872937Jenkins J, Ogden J. Becoming 'whole' again: a qualitative study of women's views of recovering from anorexia nervosa. Eur Eat Disord Rev. 2012 Jan;20(1):e23-31. doi: 10.1002/erv.1085. Epub 2011 Mar 10.
PubMed 21394835
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personal Recovery of Young Adults With Severe Anorexia Nervosa During Adolescence: a Pilot Qualitative Study
- ClinicalTrials.gov ID
- NCT03712384
- Acronym / sponsor ID
- ANAPR / PSY-2014-04
- Conditions
- Anorexia Nervosa, Eating Disorder
- Keywords
- Recovery, Qualitative research, Personal narratives
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Institut Mutualiste MontsourisUniversity, hospital or other
- Study start
- 20 Jun 2014 (actual)
- Primary completion
- 5 Jul 2014 (actual)
- Study completion
- 5 Jul 2014 (actual)
- First posted
- 19 Oct 2018 (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.
A growing qualitative literature about personal recovery process in mental disorders emerges. However in Anorexia Nervosa (AN), it remains few understood, especially in severe AN during adolescence.
This pilot study seeks to enhance understanding of recovery from AN in France and support the dissemination of the PR paradigm among the French mental health community working with AN, as a complement to the medical approach.
A qualitative research according to Interpretative Phenomenological Analysis (IPA) method was conducted .Five young women hospitalized ten years before for a severe AN during their adolescence were interviewed with a semi-structured face-to-face interview on recovery process.
Detailed description
Anorexia Nervosa (AN) is one of the most severe mental disorders with a mortality and high risk of developing chronicity. Lifetime prevalence is evaluated among women between 1.2% and 2.2%, with the higher incidence during adolescence. Recovery process remains poorly understood.
In scientific literature, recovery process of mental disorders can be seen in two different ways: the medical and the personal recovery (PR). The medical recovery is based on objective criteria, including cure (symptom disappearance), remission (symptom suspension) or therapeutic response (change of values after treatment). This medical recovery is generally studied in quantitative outcome studies. The experiential or PR is based on first person qualitative research or consensus methods, starting from patients' struggle for regaining place in their own recovery. It has become the paradigm orientation of mental health policy in anglophone countries.
A recent systematic review summeries relapse, remission or recovery criteria used in a AN outcome studies in 1-weigh measurement only; 2-symptoms reported only; 3-on both. In addition to weigh, other criteria are noticed: menstruations, psychological and behavioral features, disparities of time remission/recovery.
However, despite numerous quantitative studies, reasons for recovery, relapse or following struggle steal unclear. Medical framework is sometimes considered as reductive Moreover, those researches usually focus on risk factors, hiding protector's factors that are central for supporting recovery. Furthermore, symptom improvement is not always priority of patients(9), while improvement might happen despite symptoms persistence. Discrepancies are described in the negotiated link clinicians-patients: patient might wait for more singular and subjective approach whereas clinicians would be more invested in objective and rigorous features.
A recent systematic review offers a theorical framework to study PR in mental disorders. It is defines as an active, individual, unique, non-linearn, multidimensional and gradual process. It can be described as phase or stage, as struggle, as a life-changing experience or even as a trial or error process. It may be structured by a turning point, after when there are no turning back. It is aided by supporting and healing environment, and might occur without cure. Starting from first person narratives of mental disorders recovery, five factors supporting recovery are described: connectedness, hope and optimism about the future, identity, meaning in life, empowerment. One meta-ethnography review was published on qualitative research about PR in AN, concerning 8 studies. It provides elements on process of change, factors supporting PR and notion of empowerment and self-reconciliation.
Finally, most of PR studies come from USA, UK, Australia and Canada. Further research are needed to ground PR including cultural context. In France, AN PR has been rarely studied. These study tries to enhance understanding AN recovery in French context, to support implementation of PR paradigm among French mental health AN community; complementary to medical approach.
Study questions are: how people who suffered of severe AN and experienced hospitalization during adolescence feel and make sense to their recovery?
METHODS This study is a qualitative research with IPA, supplemented by quotation of ICD 10 criteria. We reported COREQ 32 guidelines.
Setting and participants IPA recommends homogeneous and short sampling so as to better appreciate convergences and divergences of phenomena. To maximize homogenization, very precise criteria (presented in box 1) were first chosen in order to focus on studied phenomena with in-depth way, before opening to wider study on AN recovery. Recruitment was restrained to the same hospital (Institut Mutualiste Montsouris) at the same year of hospitalization, so as to homogenize experience of care. Period of 10 years was chosen for being widely beyond largest literature mean criteria of medical recovery fixed at seven years, to get some distance with recovery process.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young adult with severe anorexia | – | Other: Semi structured face to face interviewYoung adult with severe Anorexia hospitalized during adolescence at Institut Mutualiste Montsouris |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Young people who suffered of severe AN and experienced hospitalization during adolescence feels recovered
Key inclusion criteria (8 listed)
- woman
- Adult between 20 and 30 years old
- With history of restrictive AN (CIM 10: F50)
- Without no other comorbidity
- Hospitalized for AN during adolescence (10-19 years old) ten years ago, in adolescent psychiatry at Institute Mutualiste Montsouris (France)
Key exclusion criteria (2 listed)
- Presence of AN criteria (ICD-10: F50) during research interview,
- Absence of all recovery qualitative criteria after qualitative analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semi structured face to face interviewFace-to-face semi-structured interview conducted in the hospital, where young adults were hospitalized 10 years before, in a quiet and isolated office. The topic guide was built according to literature review, without further change after pilot test. Interviews where audio-recorded and transcribed | Other | Young adult with severe anorexia |
Primary outcome
Recovery process of AN
Time frame: Semi structured face to face interview, 10 years after hospitalization for AN.
Initial interview topic guide domain 1. How have you spent your life for the first hospitalization for AN? 2. What are the factors that help or prevent from going ahead? 3. All this way long, how did feel talking about yourself? 4. How did evolve your relationships? 5. How have you felt your body all this way long? 6. How do you define recovery of AN during adolescence? 7. How would you define yourself? 8. What kind of stories do you tell yourself about AN? 9. If you would be faced with someone with current AN, what would you advice him/her?
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 15 Feb 2019.
- Background: PubMed 28630708Khalsa SS, Portnoff LC, McCurdy-McKinnon D, Feusner JD. What happens after treatment? A systematic review of relapse, remission, and recovery in anorexia nervosa. J Eat Disord. 2017 Jun 14;5:20. doi: 10.1186/s40337-017-0145-3. eCollection 2017.
- Background: PubMed 21727255Arcelus J, Mitchell AJ, Wales J, Nielsen S. Mortality rates in patients with anorexia nervosa and other eating disorders. A meta-analysis of 36 studies. Arch Gen Psychiatry. 2011 Jul;68(7):724-31. doi: 10.1001/archgenpsychiatry.2011.74.
- Background: PubMed 9356884Strober M, Freeman R, Morrell W. The long-term course of severe anorexia nervosa in adolescents: survival analysis of recovery, relapse, and outcome predictors over 10-15 years in a prospective study. Int J Eat Disord. 1997 Dec;22(4):339-60. doi: 10.1002/(sici)1098-108x(199712)22:43.0.co;2-n.
- Background: PubMed 22130746Leamy M, Bird V, Le Boutillier C, Williams J, Slade M. Conceptual framework for personal recovery in mental health: systematic review and narrative synthesis. Br J Psychiatry. 2011 Dec;199(6):445-52. doi: 10.1192/bjp.bp.110.083733.
- Background: PubMed 23349069Wollburg E, Meyer B, Osen B, Lowe B. Psychological change mechanisms in anorexia nervosa treatments: how much do we know? J Clin Psychol. 2013 Jul;69(7):762-73. doi: 10.1002/jclp.21945. Epub 2013 Jan 24.
- Background: PubMed 19225241Espindola CR, Blay SL. Anorexia nervosa's meaning to patients: a qualitative synthesis. Psychopathology. 2009;42(2):69-80. doi: 10.1159/000203339. Epub 2009 Feb 19.
- Background: PubMed 16757448Noordenbos G, Seubring A. Criteria for recovery from eating disorders according to patients and therapists. Eat Disord. 2006 Jan-Feb;14(1):41-54. doi: 10.1080/10640260500296756.
- Background: PubMed 22070426Westwood LM, Kendal SE. Adolescent client views towards the treatment of anorexia nervosa: a review of the literature. J Psychiatr Ment Health Nurs. 2012 Aug;19(6):500-8. doi: 10.1111/j.1365-2850.2011.01819.x. Epub 2011 Sep 27.
- Background: PubMed 17872937Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007 Dec;19(6):349-57. doi: 10.1093/intqhc/mzm042. Epub 2007 Sep 14.
- Background: PubMed 21394835Jenkins J, Ogden J. Becoming 'whole' again: a qualitative study of women's views of recovering from anorexia nervosa. Eur Eat Disord Rev. 2012 Jan;20(1):e23-31. doi: 10.1002/erv.1085. Epub 2011 Mar 10.
- 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. This study is not recruiting at the moment.
Marie-Aude PIOT principal investigator
Institut Mutualiste Montsouris
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 Eating Disorder, run by Institut Mutualiste Montsouris at 1 site in France.
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 8 inclusion and 2 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 15 Feb 2019. 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 France. 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?
Recovery process of AN (time frame: Semi structured face to face interview, 10 years after hospitalization for AN.). 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 NCT03712384, which also lists 10 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 15 Feb 2019.