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Construction of the Therapeutic Alliance Between Inpatient Psychiatric Patients and Nurses (ATIASP)

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. Identifier: NCT02768584
Recruitment Status : Completed
First Posted : May 11, 2016
Last Update Posted : August 13, 2018
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
Clarify the determinants of the construction of a Therapeutic Alliance (AT) between paramedical staff (nurses and caregivers ) and adult patients in a functional unit of full-time general psychiatric Whether the quality of Therapeutic Alliance influences the continued support outpatient , after completion of full-time hospitalization.

Condition or disease
Psychiatric Diseases

Detailed Description:

This is a prospective, observational, multicenter inpatient units Parisian full time of the Etablissement Public Health White House (spread over 4 sites).

The study seeks to collect, on the one hand the level of AT obtained at the end of hospitalization in general adult psychiatry and, secondly, to understand how this one was built.

The AT will be measured:

  • Firstly by the self-administered questionnaire STAR-P, translated into French by the "translation / back-translation" method.
  • Secondly through semi-structured qualitative interviews, conducted at discharge by a health care setting or a specially trained and who did not participate directly in the patient's care included. Indeed, the questionnaires allow, through scales to measure the AT quantitative way through proposals (items) presented as so, and look for associations with some predefined decisive.

However, it is difficult to explore more complex combination of mechanisms. Conducting interviews can meet this goal. An interview grid will be conducted and organized around the search for representations and affects related relational patient / nurse(s) and caregiver(s) in the context of hospital care. The interviews will be recorded and fully transcribed. A thematic analysis will be conducted to identify the objects and themes. The inclusions in this qualitative analysis will stop when reaching the saturation process. In this type of study, it is generally necessary to include thirty people to reach saturation.

Finally, semi-structured group interviews (focus group) will be conducted by co-investigators and doctoral student psychologist caregivers with the discussion topic imposed: the AT construction. They will be directed to paramedics caregivers (nurses and caregivers) are not part of the investigation team conducting research but actively involved in care. Their goal will be to harvest their representations regarding the quality of the therapeutic relationship they're trying to build with patients. A focus group will be conducted by site (4 sites), with 5 to 12 volunteers per group.

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Study Type : Observational
Actual Enrollment : 240 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Levers and Brakes to the Therapeutic Alliance Between Patients in Hospital Full-time Psychiatric and Nurses and Caregivers
Actual Study Start Date : November 6, 2015
Actual Primary Completion Date : January 11, 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Therapeutic Alliance score overall with self-administered questionnaire STAR-P [ Time Frame: day 0 ]
    AT score overall, committed to using the self-administered questionnaire STAR-P particularly suitable for "patients with severe psychiatric disorders" (Rebecca, 2007).

Secondary Outcome Measures :
  1. Number of patients reviewed in outpatient psychiatric consultation [ Time Frame: three months after hospital discharge. ]
  2. AT evaluated in patients using semi-structured interviews [ Time Frame: day 0 ]
    AT evaluated in patients using semi-structured interviews (20-40 minutes), led with an interview grid: research of representations and affects related relational patient / nurse (s) and caregiver ( s) under hospital care.

  3. AT evaluated in / nurse (s) and caregiver(s) [ Time Frame: month 6 ]
    AT evaluated in / nurse (s) and caregiver (s), through focus group: Research performances and determinants of therapeutic alliance with caregivers.

  4. Determinants of AT studied [ Time Frame: day 0 ]
    socio-demographic characteristics (age, sex, socio-professional category (CSP), educational level, profession last exercised, wage level; Marital Status; Place of birth); primary psychiatric diagnosis (ICD-10); Companion diagnostics; Total number of psychiatric hospitalizations prior to the study; which stays in Difficult Patient Unit (UMD) in Free Care, in care without consent, or at the request of a representative of the state); Stay in therapeutic isolation room during hospitalization; Length of hospital stay; Supported by a referent nurse; Highlights in the treatment period and that could presuppose an impact on the quality of care

  5. intermediate score STAR-P: score of positive collaboration [ Time Frame: day 0 ]
  6. intermediate scores STAR-P: positive contribution score [ Time Frame: day 0 ]
  7. intermediate scores STAR-P: uncooperative intake score of the nursing team and caregiver [ Time Frame: day 0 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
adult patient suffer from pyschiatric diseases except perversion disorder or paranoia

Inclusion Criteria:

  • adult patient (>18 years old)
  • Adult psychiatric inpatients

Exclusion Criteria:

  • Patients carrying perversion disorder or paranoia
  • Patients trust whose legal representative refuses participation in the survey
  • patients non covered by the french health system
  • non consenting patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02768584

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EPS Maison Blanche
Paris, France, 75018
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Principal Investigator: Jean-Manuel Morvillers, PhD centre hospitalier Maison Blanche
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Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT02768584    
Other Study ID Numbers: PHRIP 1300036N
First Posted: May 11, 2016    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

At the end of the study, patient could be informed of result of the study if they wish.

No individual result will be communicate.

Keywords provided by Assistance Publique - Hôpitaux de Paris:
severe mental illness
therapeutic alliance
psychiatric diseases
Additional relevant MeSH terms:
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Mental Disorders