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Severe Anorexia Nervosa Personal Recovery (ANAPR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03712384
Recruitment Status : Completed
First Posted : October 19, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Institut Mutualiste Montsouris

Tracking Information
First Submitted Date October 15, 2018
First Posted Date October 19, 2018
Last Update Posted Date February 15, 2019
Actual Study Start Date June 20, 2014
Actual Primary Completion Date July 5, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 18, 2018)
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?
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Severe Anorexia Nervosa Personal Recovery
Official Title Personal Recovery of Young Adults With Severe Anorexia Nervosa During Adolescence: a Pilot Qualitative Study
Brief 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.

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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Young people who suffered of severe AN and experienced hospitalization during adolescence feels recovered
Condition
  • Anorexia Nervosa
  • Eating Disorder
Intervention Other: Semi structured face to face interview
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 Groups/Cohorts Young adult with severe anorexia
Young adult with severe Anorexia hospitalized during adolescence at Institut Mutualiste Montsouris
Intervention: Other: Semi structured face to face interview
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 18, 2018)
5
Original Actual Enrollment Same as current
Actual Study Completion Date July 5, 2014
Actual Primary Completion Date July 5, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Presence of AN criteria (ICD-10: F50) during research interview,
  • Absence of all recovery qualitative criteria after qualitative analysis
Sex/Gender
Sexes Eligible for Study: Female
Ages 20 Years to 30 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03712384
Other Study ID Numbers PSY-2014-04
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Institut Mutualiste Montsouris
Study Sponsor Institut Mutualiste Montsouris
Collaborators Not Provided
Investigators
Principal Investigator: Marie-Aude PIOT Institut Mutualiste Montsouris
PRS Account Institut Mutualiste Montsouris
Verification Date February 2019