QuestionnairesHOSP-ALTNCT05431231
Testing the Effectiveness of Two Hospitalization Alternatives Compared to Psychiatric Hospitalization (HOSP-ALT)
An observational study of Questionnaires and Data Collection, run by Sheba Medical Center at 4 sites in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Questionnaires, Data Collection
- What is being tested?
- Outcome Questionnaire-45, Hopkins symptoms checklist - short form and Prodromal Questionnaire - Brief Version
- Type of treatment
- Injection or infusion
- How many people
- 180 participants
- Where
- 4 sitesIsrael
- Study dates
- 12 Feb 2020to Feb 2024
- 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: adults who are found in an acute state that requires hospitalization
Who may be able to join
- Mental condition requiring psychiatric hospitalization
- History of hospitalizations up to 5 years
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country.
Israel4 sites, 4 recruiting
- Recruiting
Soteria Home for Women
Jerusalem, 9346733
Bar Sinay, 054-726-5754 ext. 972, aptch007@gmail.com
Bar Shay, 054-796-1735 ext. 972, yovel100@gmail.com
- Recruiting
Soteria Home for Men
Jerusalem, 9510112
Lichtenberg, 050-828-8100, pesach.lichtenberg@mail.huji.ac.il
gesser, 054-450-7898, hila.gesser@gmail.com
- Recruiting
Soteria Home in the Sharon
Kfar Yona, 4032461
tzivoni, 052-382-3698 ext. 972, ytzivoni@gmail.com
Bor, 052-336-0877 ext. 972, oren_bor@yahoo.com
- Recruiting
Sheba Medical Center, Psychiatry Department
Ramat Gan
Mark Weiser, MD, +972-3-5303773, mweiser@netvision.net.il
Amit Ezra, +972-3-5303454, amit.ezra@sheba.health.gov.il
About this study
Official title: Testing the Effectiveness of Two Hospitalization Alternatives Compared to Psychiatric Hospitalization: an Open Comparative Study
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.
Read the detailed description
studies show that many of the people who were hospitalized in psychiatric wards had negative experiences. Thus, for example, patients mentioned experiences of uncertainty regarding the treatment that patients received, the rules of the psychiatric ward, length of the hospitalization, nurses' lack of time to interact with patients and even feelings of humiliation. On the other hand, patients noted that the involvement and presence of family and friends during the hospitalization aroused positive feelings. 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.
One of the first alternatives to inpatient hospitalization that was developed in Israel was Soteria. The Soteria house is a house in the community for people who are coping with extreme emotional states. The therapeutic model is based on a model that was developed in California in the beginning of the seventies by psychiatrist Dr. Loren Mosher and on additional homes in the world that were established upon his inspiration, the oldest one established in Bern, Switzerland in the eighties that is still active today. The goal of the house is to offer an alternative to inpatient psychiatric hospitalization, which would allow the coping person to get through the crisis in an open, respectful atmosphere. In the Soteria house, mental health professionals work in full cooperation with the patient's family and loved ones, with an emphasis on reducing stigma. The house is based on principles of security, open communication, nonjudgmental listening and respectful treatment as necessary conditions for coping and recovery. Every house contains up to 10 residents along with two or three guides, who are usually students who major in therapeutic professions and/or people with a history of receiving psychiatric care ("Peer Specialists"). The daily work in the house is accompanied by a group of professionals that includes a psychiatrist, a psychologist, a social worker and a nurse. In addition, the family-social circle of the resident is offered supportive conversations in the "open dialogue" spirit. The Soteria house has been active in Israel since September 2016 and so far, its effectiveness has not been studied empirically. However, numerous studies of this model were performed in the world and a meta-analysis conducted at 2008 even showed that in the short term, balancing houses decreased the symptomatic level in the same rate as psychiatric wards, while in the long term, they led to higher improvement in patients' quality of life and psycho-social functioning in comparison to inpatient hospitalization units.
Another alternative to inpatient hospitalization that has been applied recently in the Sheba Medical Center at Tel HaShomer is one of online home hospitalization. This setting is an alternative to psychiatric hospitalization that 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. The model is based on containment, lack of judgment and cooperation with figures in the community. It was established to try to reduce the damages of acute psychiatric illness, decrease the influences of stigma (that often even leads to avoidance of treatment for a long, crucial period of time) and to significantly improve the experience of the patient and his family. All the therapeutic treatments, assessment and follow-up meetings that are included in the service are provided online. Firstly, the service includes video chats with an interdisciplinary staff that includes a psychiatrist, a psychologist, a social worker, a nurse and an occupational therapist. Secondly, it involves sensors that continuously monitor behavioral data such as medication taking, and physiological data such as sleep, temperature and pulse. Thirdly, it involves reminders to take medication, to participate in follow-up meetings etc. Fourthly, a psychiatric nurse is available to the patient 24/7. Since it is not location dependent, the online service allows the entire staff (psychiatrist, psychologist, social worker) to be there for the patient continuously. Even though this model is innovative and has not yet been attempted elsewhere in the world, it is based on an extensive body of knowledge that demonstrates the effectiveness of online therapy in the treatment of psychological problems.
Despite encouraging data demonstrating the promise of hospitalization alternatives for patients' psychological wellbeing, so far, no studies compared the effectiveness of these models to that of standard psychiatric hospitalization. The goal of the current study is to try to bridge this gap through an open comparative study that examines several measures that are meant to assess the effectiveness of hospitalization alternatives in comparison to psychiatric hospitalization. Specifically, the investigators would like to explore whether there are any differences between hospitalization in psychiatric units, online home hospitalization, and staying in balancing homes in a series of qualitative, outcome and process measures. An emphasis will be made on three main components: symptomatic improvement, improvement in psycho-social functioning and improvement in patient experience. The research hypotheses are as follows:
- In accordance with previous findings, all three models would lead to similar symptomatic improvement, with no short-term differences.
- The follow-up measurements would show differences in the quality of life measures; i.e. patients' quality of life and psychological wellbeing are expected to improve significantly in the long-term among patients of both hospitalization alternatives.
- Differences in patients' satisfaction, compliance and psychosocial functioning are expected, with higher improvement rates in hospitalization alternatives compared to psychiatric hospitalization. However, the investigators do not expect to find any differences between the two hospitalization alternatives.
- Conditions
- Questionnaires, Data Collection
- Being tested
- Outcome Questionnaire-45, Hopkins symptoms checklist - short form, Prodromal Questionnaire - Brief Version, Manchester Short Assessment of Quality, Self-Stigma of Mental Illness Scale
- Keywords
- psychiatric hospitalization, hospitalization alternatives, soteria, online hospitalization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outcome Questionnaire-45Diagnostic test
Also called OQ-45
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.
Hopkins symptoms checklist - short formDiagnostic test
Also called HSCL-11
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.
Prodromal Questionnaire - Brief VersionDiagnostic test
Also called PQ-16
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.
Manchester Short Assessment of QualityDiagnostic test
Also called MANSA
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.
Self-Stigma of Mental Illness ScaleDiagnostic test
Also called SSMIS
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.
Session Alliance Inventory - for patientDiagnostic test
Also called SAI
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.
Quality of service/satisfaction questionnaireOther
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.
Clinical decision-making styleDiagnostic test
Also called CDMS
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.
Global Assessment of Functioning ScaleDiagnostic test
Also called GAF
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.
Session Alliance Inventory - for therapistDiagnostic test
Also called SAI
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Outcome Questionnaire-45; Diagnostic Test: Hopkins symptoms checklist - short form; Diagnostic Test: Prodromal Questionnaire - Brief Version; Diagnostic Test: Manchester Short Assessment of Quality; Diagnostic Test: Self-Stigma of Mental Illness Scale; Diagnostic Test: Session Alliance Inventory - for patient; Other: Quality of service/satisfaction questionnaire; Diagnostic Test: Clinical decision-making style; Diagnostic Test: Global Assessment of Functioning Scale; Diagnostic Test: Session Alliance Inventory - for therapist | |
| 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. Receives: Diagnostic Test: Outcome Questionnaire-45; Diagnostic Test: Hopkins symptoms checklist - short form; Diagnostic Test: Prodromal Questionnaire - Brief Version; Diagnostic Test: Manchester Short Assessment of Quality; Diagnostic Test: Self-Stigma of Mental Illness Scale; Diagnostic Test: Session Alliance Inventory - for patient; Other: Quality of service/satisfaction questionnaire; Diagnostic Test: Clinical decision-making style; Diagnostic Test: Global Assessment of Functioning Scale; Diagnostic Test: Session Alliance Inventory - for therapist | |
| 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. Receives: Diagnostic Test: Outcome Questionnaire-45; Diagnostic Test: Hopkins symptoms checklist - short form; Diagnostic Test: Prodromal Questionnaire - Brief Version; Diagnostic Test: Manchester Short Assessment of Quality; Diagnostic Test: Self-Stigma of Mental Illness Scale; Diagnostic Test: Session Alliance Inventory - for patient; Other: Quality of service/satisfaction questionnaire; Diagnostic Test: Clinical decision-making style; Diagnostic Test: Global Assessment of Functioning Scale; Diagnostic Test: Session Alliance Inventory - for therapist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: One year since the release from the hospital or from the alternative settings
Secondary outcomes (10)
Outcome Questionnaire-45 (OQ-45)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
a patient questionnaire that assesses quality of life. The questionnaire is composed of two parts: personal details that can change over time (education, occupational state, family state and income) and 16 questions that assess objective (4 items) and subjective (12 items) 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.
Measured: 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)
a patient questionnaire that assesses internalized self-stigma. The questionnaire is composed of four parts/dimensions: level of awareness of common stereotypes concerning others who suffer from mental illness, level of agreement with stereotypes concerning others who suffer from mental illness, the extent to which the participant has internalized these stereotypes, and the influence of the stereotypes' internalization on the participant's self-esteem. The questionnaire includes 40 items, 10 items for each dimension. 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.
Measured: 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.
Session Alliance Inventory (SAI) - To the patient
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: 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.
Quality of service/satisfaction questionnaire
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.
Measured: The questionnaire will be passed at several time points: Baseline and release from the hospital or from the alternative settings.
Clinical decision-making style (CDMS)
a questionnaire with two - patient and therapist - versions, meant to evaluate decision making style. In the current study, only the therapist/psychiatrist version would be administered once, in the beginning of the study, regarding all patients in general. 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.
Measured: Baseline
Global Assessment of Functioning Scale (GAF)
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.
Measured: 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.
Session Alliance Inventory (SAI) - To the therapist
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start12 Feb 2020
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for QuestionnairesStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431231
- Sponsor's protocol ID
- SHEBA-19-6555-MW-CTIL
- Acronym
- HOSP-ALT
- Status last verified
- Jun 2022
- First submitted
- 23 Nov 2019
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effectiveness of Two Hospitalization Alternatives Compared to Psychiatric Hospitalization: an Open Comparative Study
- ClinicalTrials.gov ID
- NCT05431231
- Acronym / sponsor ID
- HOSP-ALT / SHEBA-19-6555-MW-CTIL
- Conditions
- Questionnaires, Data Collection
- Keywords
- psychiatric hospitalization, hospitalization alternatives, soteria, online hospitalization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 24 Jun 2022 (actual)
- 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.
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.
Detailed description
studies show that many of the people who were hospitalized in psychiatric wards had negative experiences. Thus, for example, patients mentioned experiences of uncertainty regarding the treatment that patients received, the rules of the psychiatric ward, length of the hospitalization, nurses' lack of time to interact with patients and even feelings of humiliation. On the other hand, patients noted that the involvement and presence of family and friends during the hospitalization aroused positive feelings. 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.
One of the first alternatives to inpatient hospitalization that was developed in Israel was Soteria. The Soteria house is a house in the community for people who are coping with extreme emotional states. The therapeutic model is based on a model that was developed in California in the beginning of the seventies by psychiatrist Dr. Loren Mosher and on additional homes in the world that were established upon his inspiration, the oldest one established in Bern, Switzerland in the eighties that is still active today. The goal of the house is to offer an alternative to inpatient psychiatric hospitalization, which would allow the coping person to get through the crisis in an open, respectful atmosphere. In the Soteria house, mental health professionals work in full cooperation with the patient's family and loved ones, with an emphasis on reducing stigma. The house is based on principles of security, open communication, nonjudgmental listening and respectful treatment as necessary conditions for coping and recovery. Every house contains up to 10 residents along with two or three guides, who are usually students who major in therapeutic professions and/or people with a history of receiving psychiatric care ("Peer Specialists"). The daily work in the house is accompanied by a group of professionals that includes a psychiatrist, a psychologist, a social worker and a nurse. In addition, the family-social circle of the resident is offered supportive conversations in the "open dialogue" spirit. The Soteria house has been active in Israel since September 2016 and so far, its effectiveness has not been studied empirically. However, numerous studies of this model were performed in the world and a meta-analysis conducted at 2008 even showed that in the short term, balancing houses decreased the symptomatic level in the same rate as psychiatric wards, while in the long term, they led to higher improvement in patients' quality of life and psycho-social functioning in comparison to inpatient hospitalization units.
Another alternative to inpatient hospitalization that has been applied recently in the Sheba Medical Center at Tel HaShomer is one of online home hospitalization. This setting is an alternative to psychiatric hospitalization that 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. The model is based on containment, lack of judgment and cooperation with figures in the community. It was established to try to reduce the damages of acute psychiatric illness, decrease the influences of stigma (that often even leads to avoidance of treatment for a long, crucial period of time) and to significantly improve the experience of the patient and his family. All the therapeutic treatments, assessment and follow-up meetings that are included in the service are provided online. Firstly, the service includes video chats with an interdisciplinary staff that includes a psychiatrist, a psychologist, a social worker, a nurse and an occupational therapist. Secondly, it involves sensors that continuously monitor behavioral data such as medication taking, and physiological data such as sleep, temperature and pulse. Thirdly, it involves reminders to take medication, to participate in follow-up meetings etc. Fourthly, a psychiatric nurse is available to the patient 24/7. Since it is not location dependent, the online service allows the entire staff (psychiatrist, psychologist, social worker) to be there for the patient continuously. Even though this model is innovative and has not yet been attempted elsewhere in the world, it is based on an extensive body of knowledge that demonstrates the effectiveness of online therapy in the treatment of psychological problems.
Despite encouraging data demonstrating the promise of hospitalization alternatives for patients' psychological wellbeing, so far, no studies compared the effectiveness of these models to that of standard psychiatric hospitalization. The goal of the current study is to try to bridge this gap through an open comparative study that examines several measures that are meant to assess the effectiveness of hospitalization alternatives in comparison to psychiatric hospitalization. Specifically, the investigators would like to explore whether there are any differences between hospitalization in psychiatric units, online home hospitalization, and staying in balancing homes in a series of qualitative, outcome and process measures. An emphasis will be made on three main components: symptomatic improvement, improvement in psycho-social functioning and improvement in patient experience. The research hypotheses are as follows:
- In accordance with previous findings, all three models would lead to similar symptomatic improvement, with no short-term differences.
- The follow-up measurements would show differences in the quality of life measures; i.e. patients' quality of life and psychological wellbeing are expected to improve significantly in the long-term among patients of both hospitalization alternatives.
- Differences in patients' satisfaction, compliance and psychosocial functioning are expected, with higher improvement rates in hospitalization alternatives compared to psychiatric hospitalization. However, the investigators do not expect to find any differences between the two hospitalization alternatives.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| psychiatric ward | – | Diagnostic Test: Outcome Questionnaire-45, Diagnostic Test: Hopkins symptoms checklist - short form, Diagnostic Test: Prodromal Questionnaire - Brief Version, Diagnostic Test: Manchester Short Assessment of Quality, Diagnostic Test: Self-Stigma of Mental Illness Scale, Diagnostic Test: Session Alliance Inventory - for patient, Other: Quality of service/satisfaction questionnaire, Diagnostic Test: Clinical decision-making style, Diagnostic Test: Global Assessment of Functioning Scale, Diagnostic Test: Session Alliance Inventory - for therapistAdults 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 | – | Diagnostic Test: Outcome Questionnaire-45, Diagnostic Test: Hopkins symptoms checklist - short form, Diagnostic Test: Prodromal Questionnaire - Brief Version, Diagnostic Test: Manchester Short Assessment of Quality, Diagnostic Test: Self-Stigma of Mental Illness Scale, Diagnostic Test: Session Alliance Inventory - for patient, Other: Quality of service/satisfaction questionnaire, Diagnostic Test: Clinical decision-making style, Diagnostic Test: Global Assessment of Functioning Scale, Diagnostic Test: Session Alliance Inventory - for therapistadults 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 | – | Diagnostic Test: Outcome Questionnaire-45, Diagnostic Test: Hopkins symptoms checklist - short form, Diagnostic Test: Prodromal Questionnaire - Brief Version, Diagnostic Test: Manchester Short Assessment of Quality, Diagnostic Test: Self-Stigma of Mental Illness Scale, Diagnostic Test: Session Alliance Inventory - for patient, Other: Quality of service/satisfaction questionnaire, Diagnostic Test: Clinical decision-making style, Diagnostic Test: Global Assessment of Functioning Scale, Diagnostic Test: Session Alliance Inventory - for therapistadults 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adults who are found in an acute state that requires hospitalization
Key inclusion criteria (2 listed)
- Mental condition requiring psychiatric hospitalization
- History of hospitalizations up to 5 years
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Outcome Questionnaire-45Also: OQ-45a 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. | Diagnostic test | Online hospitalization, Soteria, psychiatric ward |
| Hopkins symptoms checklist - short formAlso: HSCL-11a 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. | Diagnostic test | Online hospitalization, Soteria, psychiatric ward |
| Prodromal Questionnaire - Brief VersionAlso: PQ-16a 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. | Diagnostic test | Online hospitalization, Soteria, psychiatric ward |
| Manchester Short Assessment of QualityAlso: MANSAa 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. | Diagnostic test | Online hospitalization, Soteria, psychiatric ward |
| Self-Stigma of Mental Illness ScaleAlso: SSMISa 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. | Diagnostic test | Online hospitalization, Soteria, psychiatric ward |
| Session Alliance Inventory - for patientAlso: SAIthis 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. | Diagnostic test | Online hospitalization, Soteria, psychiatric ward |
| Quality of service/satisfaction questionnairemeasured 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. | Other | Online hospitalization, Soteria, psychiatric ward |
| Clinical decision-making styleAlso: CDMSa 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. | Diagnostic test | Online hospitalization, Soteria, psychiatric ward |
| Global Assessment of Functioning ScaleAlso: GAFa 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. | Diagnostic test | Online hospitalization, Soteria, psychiatric ward |
| Session Alliance Inventory - for therapistAlso: SAIa 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. | Diagnostic test | Online hospitalization, Soteria, psychiatric ward |
Primary outcome
Frequency of repeated hospitalizations after release from each setting.
Time frame: One year since the release from the hospital or from the alternative settings
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.
Duration of hospitalizations.
Time frame: One year since the release from the hospital or from the alternative settings
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.
10 secondary outcomes
Outcome Questionnaire-45 (OQ-45)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Session Alliance Inventory (SAI) - To the patient
Time frame: 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.
Quality of service/satisfaction questionnaire
Time frame: The questionnaire will be passed at several time points: Baseline and release from the hospital or from the alternative settings.
Clinical decision-making style (CDMS)
Time frame: Baseline
Global Assessment of Functioning Scale (GAF)
Time frame: 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.
Session Alliance Inventory (SAI) - To the therapist
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Questionnaires and Data Collection, run by Sheba Medical Center at 4 sites in Israel.
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 5 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: status not confirmed, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Friedlander (050-6801173 ext. 972, avremi13@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of repeated hospitalizations after release from each setting. (time frame: One year since the release from the hospital or from the alternative settings). The study lists 2 primary outcomes in all. 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 24 Jun 2022.