Testing the Effectiveness of Two Hospitalization Alternatives Compared to Psychiatric Hospitalization (HOSP-ALT)
HOSP-ALT
1 other identifier
observational
180
1 country
4
Brief Summary
studies show that many of the people who were hospitalized in psychiatric wards had negative experiences of their stay there. These reports regarding patients' experiences have led in recent years to the development of several hospitalization alternatives that were meant to improve patients' experiences in an acute time in their lives, out of hope that the staying in a familiar and safe place and in one's natural environment will allow better recovery. The current study, is an open comparative study. Testing the effectiveness of two hospitalization alternatives compared to psychiatric hospitalization. First alternative is called Soteria. a house in the community for people who are coping with extreme emotional states. The goal of the house is to allow the coping person to get through the crisis in an open, respectful atmosphere. Second alternative is online home hospitalization. The model uses technological solutions to allow management of effective, integrative treatment for people who are coping with extreme emotional states while they remain in their homes. this model is innovative and has not yet been attempted elsewhere in the world. The goal of the current study is to explore whether there are any differences between hospitalization in psychiatric units, online home hospitalization, and staying in Soteria homes in a series of qualitative, outcome and process measures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2020
Longer than P75 for all trials
4 active sites
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
First Submitted
Initial submission to the registry
November 23, 2019
CompletedStudy Start
First participant enrolled
February 12, 2020
CompletedFirst Posted
Study publicly available on registry
June 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2024
CompletedJune 24, 2022
June 1, 2022
3 years
November 23, 2019
June 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Frequency of repeated hospitalizations after release from each setting.
For each subject will be measured, the number of times they have been hospitalized In a psychiatric ward or its alternatives, since the beginning of the study.
One year since the release from the hospital or from the alternative settings
Duration of hospitalizations.
For each subject will be measured, the number of days that they stayed In a psychiatric ward or its alternatives. In all hospitalizations together (For those who have been hospitalized several times) since the beginning of the study.
One year since the release from the hospital or from the alternative settings
Secondary Outcomes (10)
Outcome Questionnaire-45 (OQ-45)
The questionnaire will be passed at several time points: Baseline and 6, 12 and 18 months since the release from the hospital or from the alternative settings.
Hopkins symptoms checklist - short form (HSCL-11)
The questionnaire will be passed at several time points: Baseline and release from the hospital or from the alternative settings and 3 months since the release from the hospital or from the alternative settings.
Prodromal Questionnaire - Brief Version (PQ-16)
The questionnaire will be passed at several time points: Baseline and release from the hospital or from the alternative settings and 3, 6, 12 and 18 months since the release from the hospital or from the alternative settings.
Manchester Short Assessment of Quality (MANSA)
The questionnaire will be passed at several time points: Baseline and release from the hospital or from the alternative settings and 3, 6, 12 and 18 months since the release from the hospital or from the alternative settings.
Self-Stigma of Mental Illness Scale (SSMIS)
The questionnaire will be passed at several time points: Baseline and release from the hospital or from the alternative settings and 3, 6, 12 and 18 months since the release from the hospital or from the alternative settings.
- +5 more secondary outcomes
Study Arms (3)
psychiatric ward
Adults consenting to treatment, who are admitted in the psychiatric ward at the Sheba Medical Health Center, whose first hospitalization has been up to five years before their current referral.
Online hospitalization
adults consenting to treatment in their homes, who are found in an acute state that requires hospitalization, whose first hospitalization has been up to five years before their current referral. All the therapeutic treatments, assessment and follow-up meetings that are included in the service are provided online.
Soteria
adults consenting to treatment in a house in the community, who are found in an acute state that requires hospitalization, whose first hospitalization has been up to five years before their current referral.
Interventions
a questionnaire that evaluates the patient's level of distress. The questionnaire was developed by Lambert et al. in 1996 and was translated to Hebrew by Gross, Glasser, Elisha et al. in 2015. The questionnaire is composed of 45 statements that describe emotional states, assessing three main components: subjective discomfort, interpersonal relationships and performance of social roles. The participants are asked to rate how often they have felt the states described by each statement using a five-level Likert scale (0 - never, 4 - almost always). This questionnaire has been used extensively and has showed good internal consistence of 0.93 for its English version and 0.91 for its Hebrew version.
a questionnaire for assessing symptomatic distress. The questionnaire was developed by Lutz, Tholen, Schürch, and Berking in 2006. It is a short version of the SCL-90-R, that was developed by Derogatis in 1992. The checklist includes 11 items that describe negative feelings and thoughts. Participants are asked to rate the extent to which a given feeling or thought has troubled them in the past week using a four-level Likert scale (1 - not at all, 4 - very much). This tool is highly correlated with the Global Severity Index (r=.91) and has shown high internal consistency.
a patient questionnaire that assesses the existence of a prodromal state or fully developed psychosis. It was developed by Ising et al. in 2012 and was translated to Hebrew by Koren et al. in 2016. The tool is based on a more extensive questionnaire - PQ-92 - that was developed by Loewy et al. in 2005 - and constitutes an attempt to create an improved shorter version. The PQ-16 includes 16 items that refer to thoughts, feelings and experiences that describe various symptoms, including abnormal perception (9 items), unconventional thinking and paranoia (5 items) and negative symptoms (2 items). For each item, first, the participant is asked to indicate whether he had experienced that phenomenon in the past month, and if he had, he is asked to describe the extent to which the phenomenon had caused him distress, using a four-level Likert scale (0 - no distress, 3 - severe distress). Ising et al. found that Kronbach's α was 0.774 for the whole questionnaire.
a patient questionnaire that assesses quality of life. This questionnaire was developed by Priebe, Huxley, Knight and Evans in 1999. It is based on a longer questionnaire - Lancashire Quality of Life Profile (LQLP) - and was created as an attempt to form an improved shorter version. The questionnaire is composed of two parts: personal details that can change over time and 16 questions that assess objective and subjective quality of life. The objective items are presented as yes or no questions, while regarding the subjective items, participants are asked to describe, using a 7-level Likert scale, the extent to which they are satisfied with their lives. Priebe et al. reported an alpha internal consistency of 0.74.
a patient questionnaire that assesses internalized self-stigma. It was developed by Corrigan, Watson, and Barr in 2006. The questionnaire is composed of four dimensions. The questionnaire includes 40 items, 10 items for each dimension. The participant is asked to rate the extent to which he agrees with each item using a 9-level Likert scale. The questionnaire yields four separate scores for each dimension, and each dimension can be administered separately and independently. In the current study, only one 10-item dimension will be administered - the extent to which the participant has internalized stereotypes concerning mental illness. Corrigan et al (2006) reported an internal consistency alpha of 0.81 and a test-retest reliability ratio of 0.82 for this dimension.
this questionnaire has two versions, one for patients and one for the main therapist in the therapeutic team, and its goal is to evaluate the therapist-patient relationship (therapeutic alliance). It is composed of 6 statements that relate to the therapeutic relationship. The participants are asked to rate the extent to which the statements describe their experience accurately using a 7-level Likert scale (1 - does not describe my experience in any way, 7 - describes my experience exactly). In the current study, patients will define who their main therapist is. Falkenstrom et al. reported that in their three tested samples, the alpha coefficients ranged from 0.89 to 0.94.
measured by the quality of service department at Sheba Medical Health Center (or - PROMS, to be decided). Here customer's experience of the online services would be measured as well.
a questionnaire with two - patient and therapist - versions, meant to evaluate decision making style. It was developed by Puschner, Neumann, Jordan, et al. in 2013. The questionnaire constitutes a modified version of the Autonomy Preference Index (API), which was developed by Ende, Kazis, Ash, \& Moskowitz in 1989 for mental health patients. In the current study, only the therapist/psychiatrist version would be administered. The questionnaire is composed of 21 items and yields two components related to clinical decision making: preferences in decision making style and information seeking during decision making. Puschner et al (2013) reported that Kronbach's α coefficient ranged from 0.87 to 0.89.
a questionnaire meant to assess the patient's global functioning. It was developed by Jones, Thornicroft, Coffey, \& Dunn in 1996. The GAF was used in DSM-IV as the fifth axis of psychiatric evaluation. The therapist is asked to determine for each patient a general score ranging from 10 to 100 to describe his everyday functioning in psychological, social and occupational fields. A score of 10 refers to a state of persistent danger of severely hurting the self or others, and a score of 100 refers to superior functioning in all areas of life. Jones et al. reported that Kronbach's α ranged from 0.74 to 0.76.
a questionnaire that has two - patient and therapist - versions, meant to assess the therapist-patient relationship (therapeutic alliance). It was developed by Falkenstrom, Hatcher, Skjulsvik, Larsson, \& Holmqvist in 2014. Each questionnaire (patient/therapist) is composed of 6 statements that refer to the therapeutic relationship. The participants are asked to rate the extent to which the statements describe their experience accurately using a 7-level Likert scale (1 - does not describe my experience in any way, 7 - describes my experience exactly). Falkenstrom et al reported that Kronbach's α coefficient ranged from 0.89 to 0.94 for their three tested samples. In the current study, patients will define who their main therapist is.
Eligibility Criteria
adults who are found in an acute state that requires hospitalization
You may qualify if:
- Mental condition requiring psychiatric hospitalization
- History of hospitalizations up to 5 years
You may not qualify if:
- A condition requiring forced hospitalization
- poor compliance with treatment
- developmental cognitive disability
- complex organic states including dementia
- patients with severe comorbidity such as substance abuse (drugs, alcohol)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Soteria Home for Women
Jerusalem, 9346733, Israel
Soteria Home for Men
Jerusalem, 9510112, Israel
Soteria Home in the Sharon
Kfar Yona, 4032461, Israel
Sheba Medical Center, Psychiatry Department
Ramat Gan, Israel
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2019
First Posted
June 24, 2022
Study Start
February 12, 2020
Primary Completion
February 1, 2023
Study Completion
February 1, 2024
Last Updated
June 24, 2022
Record last verified: 2022-06