Clinical trial NCT02768584: Construction of the Therapeutic Alliance Between Inpatient Psychiatric Patients and Nurses
Official title: Levers and Brakes to the Therapeutic Alliance Between Patients in Hospital Full-time Psychiatric and Nurses and Caregivers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychiatric Diseases
Keywords: severe mental illness
nursing
therapeutic alliance
psychiatric diseases
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patient suffer from pyschiatric diseases except perversion disorder or paranoia

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Therapeutic Alliance score overall with self-administered questionnaire STAR-P
timeFrame: day 0
Secondary outcomes:
measure: Number of patients reviewed in outpatient psychiatric consultation
timeFrame: three months after hospital discharge.
measure: AT evaluated in patients using semi-structured interviews
timeFrame: day 0
measure: AT evaluated in / nurse (s) and caregiver(s)
timeFrame: month 6
measure: Determinants of AT studied
timeFrame: day 0
measure: intermediate score STAR-P: score of positive collaboration
timeFrame: day 0
measure: intermediate scores STAR-P: positive contribution score
timeFrame: day 0
measure: intermediate scores STAR-P: uncooperative intake score of the nursing team and caregiver
timeFrame: day 0
Other outcomes:
Locations:
city: Paris
country: France
facility: EPS Maison Blanche
Study officials:
affiliation: centre hospitalier Maison Blanche
name: Jean-Manuel Morvillers, PhD
role: PRINCIPAL_INVESTIGATOR
References: