Psychiatric DiseasesATIASPNCT02768584
Construction of the Therapeutic Alliance Between Inpatient Psychiatric Patients and Nurses
An observational study of Psychiatric Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychiatric Diseases
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- 6 Nov 2015to Jun 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patient suffer from pyschiatric diseases except perversion disorder or paranoia
Who may be able to join
- adult patient (>18 years old)
- Adult psychiatric inpatients
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Levers and Brakes to the Therapeutic Alliance Between Patients in Hospital Full-time Psychiatric and Nurses and Caregivers
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.
Read the 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.
- Conditions
- Psychiatric Diseases
- Keywords
- severe mental illness, nursing, therapeutic alliance, psychiatric diseases
- Medical subject headings
- Mental Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: day 0
Secondary outcomes (7)
Number of patients reviewed in outpatient psychiatric consultation
Measured: three months after hospital discharge.
AT evaluated in patients using semi-structured interviews
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.
Measured: day 0
AT evaluated in / nurse (s) and caregiver(s)
AT evaluated in / nurse (s) and caregiver (s), through focus group: Research performances and determinants of therapeutic alliance with caregivers.
Measured: month 6
Determinants of AT studied
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
Measured: day 0
intermediate score STAR-P: score of positive collaboration
Measured: day 0
intermediate scores STAR-P: positive contribution score
Measured: day 0
intermediate scores STAR-P: uncooperative intake score of the nursing team and caregiver
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study start6 Nov 2015
- Primary completion11 Jan 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DiseasesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Manuel Morvillers, PhD, Principal investigator, centre hospitalier Maison Blanche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768584
- Sponsor's protocol ID
- PHRIP 1300036N
- Acronym
- ATIASP
- Status last verified
- Jul 2018
- First submitted
- 16 Mar 2016
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: At the end of the study, patient could be informed of result of the study if they wish. No individual result will be communicate.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levers and Brakes to the Therapeutic Alliance Between Patients in Hospital Full-time Psychiatric and Nurses and Caregivers
- ClinicalTrials.gov ID
- NCT02768584
- Acronym / sponsor ID
- ATIASP / PHRIP 1300036N
- Conditions
- Psychiatric Diseases
- Keywords
- severe mental illness, nursing, therapeutic alliance, psychiatric diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 6 Nov 2015 (actual)
- Primary completion
- 11 Jan 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 11 May 2016 (estimated)
- 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.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patient suffer from pyschiatric diseases except perversion disorder or paranoia
Key inclusion criteria (2 listed)
- adult patient (>18 years old)
- Adult psychiatric inpatients
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
7 secondary outcomes
Number of patients reviewed in outpatient psychiatric consultation
Time frame: three months after hospital discharge.
AT evaluated in patients using semi-structured interviews
Time frame: day 0
AT evaluated in / nurse (s) and caregiver(s)
Time frame: month 6
Determinants of AT studied
Time frame: day 0
intermediate score STAR-P: score of positive collaboration
Time frame: day 0
intermediate scores STAR-P: positive contribution score
Time frame: day 0
intermediate scores STAR-P: uncooperative intake score of the nursing team and caregiver
Time frame: day 0
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 13 Aug 2018.
- Individual participant dataSharing planned: No. At the end of the study, patient could be informed of result of the study if they wish. No individual result will be communicate.
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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.
Jean-Manuel Morvillers, PhD principal investigator
centre hospitalier Maison Blanche
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 Psychiatric Diseases, run by Assistance Publique - Hôpitaux de Paris 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 2 inclusion and 4 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 13 Aug 2018. 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?
Therapeutic Alliance score overall with self-administered questionnaire STAR-P (time frame: day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2018.