NCT02768584

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 6, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

August 13, 2018

Status Verified

July 1, 2018

Enrollment Period

2.2 years

First QC Date

March 16, 2016

Last Update Submit

August 10, 2018

Conditions

Psychiatric Diseases

Keywords

severe mental illnessnursingtherapeutic alliancepsychiatric diseases

Outcome Measures

Primary Outcomes (1)

  • Therapeutic Alliance score overall with self-administered questionnaire STAR-P

    AT score overall, committed to using the self-administered questionnaire STAR-P particularly suitable for "patients with severe psychiatric disorders" (Rebecca, 2007).

    day 0

Secondary Outcomes (7)

  • Number of patients reviewed in outpatient psychiatric consultation

    three months after hospital discharge.

  • AT evaluated in patients using semi-structured interviews

    day 0

  • AT evaluated in / nurse (s) and caregiver(s)

    month 6

  • Determinants of AT studied

    day 0

  • intermediate score STAR-P: score of positive collaboration

    day 0

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult patient suffer from pyschiatric diseases except perversion disorder or paranoia

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EPS Maison Blanche

Paris, 75018, France

Location

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Jean-Manuel Morvillers, PhD

    centre hospitalier Maison Blanche

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2016

First Posted

May 11, 2016

Study Start

November 6, 2015

Primary Completion

January 11, 2018

Study Completion

June 1, 2018

Last Updated

August 13, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

At the end of the study, patient could be informed of result of the study if they wish. No individual result will be communicate.

Locations

FR(1)