Clinical trial NCT05431231: Testing the Effectiveness of Two Hospitalization Alternatives Compared to Psychiatric Hospitalization (HOSP-ALT)
Official title: Testing the Effectiveness of Two Hospitalization Alternatives Compared to Psychiatric Hospitalization: an Open Comparative Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Questionnaires
Data Collection
Keywords: psychiatric hospitalization
hospitalization alternatives
soteria
online hospitalization
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2022-06-24
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adults who are found in an acute state that requires hospitalization

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.

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:

1. In accordance with previous findings, all three models would lead to similar symptomatic improvement, with no short-term differences.
2. 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.
3. 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.

Eligibility criteria: Inclusion Criteria:

* Mental condition requiring psychiatric hospitalization
* History of hospitalizations up to 5 years

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Frequency of repeated hospitalizations after release from each setting.
timeFrame: One year since the release from the hospital or from the alternative settings
measure: Duration of hospitalizations.
timeFrame: One year since the release from the hospital or from the alternative settings
Secondary outcomes:
measure: Outcome Questionnaire-45 (OQ-45)
timeFrame: 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.
measure: Hopkins symptoms checklist - short form (HSCL-11)
timeFrame: 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.
measure: Prodromal Questionnaire - Brief Version (PQ-16)
timeFrame: 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.
measure: Manchester Short Assessment of Quality (MANSA)
timeFrame: 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.
measure: Self-Stigma of Mental Illness Scale (SSMIS)
timeFrame: 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.
measure: Session Alliance Inventory (SAI) - To the patient
timeFrame: 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.
measure: Quality of service/satisfaction questionnaire
timeFrame: The questionnaire will be passed at several time points: Baseline and release from the hospital or from the alternative settings.
measure: Clinical decision-making style (CDMS)
timeFrame: Baseline
measure: Global Assessment of Functioning Scale (GAF)
timeFrame: 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.
measure: Session Alliance Inventory (SAI) - To the therapist
timeFrame: 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.
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Soteria Home for Women
city: Jerusalem
country: Israel
facility: Soteria Home for Men
city: Kfar Yona
country: Israel
facility: Soteria Home in the Sharon
city: Ramat Gan
country: Israel
facility: Sheba Medical Center, Psychiatry Department
Study officials:
References: