Anxiety DisorderNCT03608449
Doing More With Less": Optimizing Psychotherapeutic Services in the Mental Health System
A study testing questionnaires in people with Anxiety Disorder and Affective Disorders, run by Shalvata Mental Health Center.
Trial summary
Psychotherapy is one of the cornerstones of mental health services. It is provided by psychiatrist, psychologists and psychiatric social worker in both hospital and out-patient services, and is assumed to require massive manpower and training inputs. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety Disorder, Affective Disorders, Personality Disorders
- What is being tested?
- questionnaires
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2018to 1 Sep 2020
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All enrolled patients must have a mobile phone capable of hosting the ROM-on-mobile system.
- patients with anxiety/ affective (depressive and bi-polar)/ personality disorders
Who cannot join
- Patients exceeding 65 years at their date of admission,
- Patients with impaired Hebrew fluency (difficulties in either reading or writing),
- Evidence of organic brain syndrome or mental retardation,
- Patients with psychotic disorders (e.g. - schizophrenia, delusional disorders)
- Evidence of probable need for hospitalization,
- Patients admitted only for diagnostic purposes,
- Patients unwilling to be enrolled in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Psychotherapy is one of the cornerstones of mental health services. It is provided by psychiatrist, psychologists and psychiatric social worker in both hospital and out-patient services, and is assumed to require massive manpower and training inputs.
Internationally, the clinical outcomes of routine mental health services are rarely recorded or reported. However, a rough estimation is that half (40-60%) of all psychotherapies have a favorable clinical outcome. Recently (Clark et al, 2017), the English Improving Access to Psychological Therapies (IAPT) Program, which delivers psychotherapies to more than 537 000 patients in the UK each year, indicated that 44% of the patients recovered, and 62%- improved. Consistent with a causal model, most organizational factors also predicted between-year changes in outcome, together accounting for 33% of variance in reliable improvement and 22% for reliable recovery.
The proposed study aims at dramatically improving the yield of psychotherapies in the Mental Health Services by combining monitoring and patient-therapist matching strategies. The first will be achieved by implementing Routine Outcome Monitoring (ROM), and the second- by applying a patient-therapist match-re-match procedure during psychotherapy
Read the detailed description
Routine Outcome Monitoring Routine Outcome Monitoring (ROM) enables systematic assessment of treatment outcomes at regular intervals for monitoring the progress of patients during treatment. ROM was originally developed for clinical studies, thus providing quality feedback for research and clinical purposes. There is accumulated evidence that ROM has positive effects for supporting care, for research and for management.
As of the beginning of the previous decade, ROM projects have developed and integrated into national health systems (e.g. Australia and New Zealand, England, etc.) and in various research groups around the world (e.g. Holland, Italy, USA, Canada, (Ruggeri, 2002; Burgess et al., 2012; Mellor-Clarket al., 2006) .In recent years, computer software has been widely used to collect, analyze and manage information in a secure, efficient and accessible manner, providing ongoing feedback to caregivers (Barkham et al., 2001; Barkham \& Mellor-Clark, 2003; Margison et al., 2000).
Routine outcome monitoring can enable achieving several goals that directly contribute to treatment (De Beurs et al., 2011). It provides quality feedback to clinicians and patients in real time about the progress of the treatment and the early identification of various problems such as negative response to therapy. This increases the positive response to the treatment, balances the therapist's biases in an optimistic or pessimistic direction, supports decisions in treatment and improves the cooperation between the therapist and the patient. Hence, patients' involvement in the therapeutic process, their commitment to it, and their satisfaction (Whipple \& Lambert, 2011), Lambert, 2010 (Priebe et al., 2002) also improve. A group of studies has shown that frequent monitoring of the evaluation of the therapeutic relationship during psychotherapy enables better real-time identification of therapeutic ruptures that can be corrected (Muran et al. 2009; Safran et al., 2011). In psychiatric work with more severe patients, it was demonstrated that there was a correlation between ROM and a significant reduction in the number and duration of hospitalizations, a finding that has a significant economic significance (Slade et al., 2006). In a meta-analysis review published in 2009 (12 studies, 2001-2006) a significant short-term symptomatic improvement and some long-term improvements was shown in monitored therapies. In another review (Shimokawa et al., 2010), a weekly measure of personal well-being measures had a significant positive impact on the quality, duration and outcome of treatment, especially in patients prone to dropout. Despite initial objections among teams to introduce quantitative measurements into their work, various attempts have shown that after assimilation, staff satisfaction from the systems is great and serves as a complement to individual work and staff meetings (de Beurs et al., 2011).
The collection of the broad information in the ROM is also used for managerial purposes (Trauer, 2010). For example, the accumulated information can be used for ongoing epidemiological research of treatments as they actually occur in a heterogeneous clinical environment and may maximize resources utilization (Coombs et al., 2011). The information produced (on the organizational, local, regional or national levels) is more likely to have higher predictive validity than information extracted from incidental questioning patients for improvement. Effective evaluations of various treatment approaches have also been made, and it is important to consider that treatments are indeed effective in the particular clinical setting they are provided, and not only in controlled studies under very different conditions (Stiles et al., 2008). Applying ROM appears to be more effective when integrated in a formalized and structured manner (Krägeloh, 2015). In such terms, it may be a powerful managerial tool, balancing between the patient's expectations and needs and the mental health care capacity. It is thus surprising, as recently noted by Jensen-Doss (2018), that ROM rarely used in practice, even though it is viewed favorably.
Despite current enthusiasm, advances in implementation, and the growing belief among some proponents and policymakers that ROM represents a major revolution in the practice of psychotherapy, other research has suggested that the focus on measurement and monitoring is in danger of missing the point (Miller et al., 2015). Research from the field of expertise and expert performance provides guidance for realizing the full potential of ROM. One crucial element in optimizing the effect of the ROM is that the decisions derived from continuously collecting the outcome measures will be taken with the patient (and not just shared with him/her). As shown by Clarke et al. (2015), more active involvement in decision-making than the patient stated as desired was associated with higher satisfaction. A clinical orientation towards empowering, rather than shared, decision-making may maximize satisfaction and optimize the effect ROM may have on clinical practice.
Implementation of novel strategies in the field of psychiatry may result in substantial cost reduction (van Londen, 2016) Patient-therapist matching in psychotherapy Research on fitting treatment procedures to the unique needs and proclivities of patients is limited. Traditional research on efficacy of psychotherapy focuses on the role of interventions and theoretical brands, minimizing factors that cannot be randomly assigned. This line of research has not realized its initial and desired promise, perhaps because it fails to incorporate into the study of psychotherapy important and effective treatment variations that are associated with therapist and non-diagnostic patient factors (Beutler, 2015).
The possibility to match patient to therapist by pre-treatment data did not succeed. Many factors were found to contribute to good outcome in psychotherapies. These include patient's factors (e.g.- high levels of motivation and involvement with positive, but realistic attitude), therapist's factors (e.g.- training and supervision) and relational factors (strength of therapeutic alliance is a leading factor; other factors are of moderate- to poor-correlation to outcome) (Cooper, 2008).
While it is accepted that pre-treatment patient-therapist match will not do, the possibility to re-match patient-therapist dyads in case of unsuccessful therapies clinically sounds. Surprisingly, to our best knowledge, this possibility was never examined. Thus, while the ROM clearly indicates whether the trajectory of a given psychotherapy is favorable, it is not examined for initiating patient-therapist re-matching in therapies with poor outcome. This can be attributed to the personal and protected nature of the psychotherapy, generally perceived as indifferent to external observation.
RESEARCH ASSUMPTIONS Co-implementation of patient- and therapist-based routine monitoring tools with matching/re-matching strategies will promote therapy outcome in 25% and will not reduce total patients' satisfaction.
As measured in cost-effectiveness values, our secondary assumption is that co-implementation of monitoring-\&-managing systems will reduce 28% of mental health costs in the unit examined.
STUDY DESIGN The study (see Figure 1 attached at the end of the proposal) will span over 21 months, of which 14 months will be dedicated for assessing the effect of monitoring-\&-matching system in one out-patient intensive mental health facility.
The study will be performed in the Day Care Department (DCD) of the Shalvata Mental Health Center (SMHC). This unit treats patients who suffer from psychiatric disorders but do not require full hospitalization. The DCD is part of the SMHC out-patient network, and admits patients directly from the community (half-way in). The department has a diverse team (30 professionals) of psychiatrists, psychologists, social workers, occupational therapists, expressive therapists and nursing staff, and receives about 10-15 patients each month. The DCD is ideal for testing new therapeutic strategies in the field of psychiatry: it supplies intensive care (thus enabling frequent monitoring of the patient's condition), it operates in large volumes (i.e., can quickly examine proposals for implementing treatment systems), it is backed by sophisticated information systems (Chameleon; an integrated electronic medical record system) and as it is situated "in-between" the hospitalizing and ambulatory systems (it covers both of them).
The proposed study in a pilot study, thus focusing on a relatively small number of participants. Altogether, one hundred patients will be enrolled in the study, randomized-by-order to either the monitored-\&-matched ("re-matched") group, or the treated-as-usual (TAU) group. Enrolled patients of the two groups will be followed for their entire day-care period, or to a period of 3 months (the shorter of the two). Follow up will include in both re-matched and TAU groups formalized (SCID) and an array of self-reported questionnaires (see below). Patients and therapists of the both group will routinely complete ROM questionnaires, as well as mid- and end-term questionnaires evaluating their condition and satisfaction; only patients of the re-matched group will be matched/re-matched (see below).
- Conditions
- Anxiety Disorder, Affective Disorders, Personality Disorders
- Being tested
- questionnaires
- Medical subject headings
- Anxiety Disorders, Mood Disorders, Personality Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesOther
questionnaire about mental health status during psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| study group | Active comparator | after monitoring treatment outcomes for 4 weeks, treatment plan or psychotherpist will be changed according to scoring by the director of department. Receives: Other: questionnaires |
| control group | Placebo comparator | treatment as usual. treatment counitunes as usual without depending on monitoring treatment outcomes. Receives: Other: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
OQ-45 (outcome measure)
is the most commonly-used outcome measure in psychotherapy. It provides both a measure of weekly change on which the feedback to therapists and patients was based and the criterion measure for classification of a patient into an outcome group on a scale of 0 ("never") to 4 ("always")
Measured: up to 14 months
SEQ (session outcome)
The SEQ-4 validates the WAI-6, and allows the better identification of sessions in which ruptures and repairs occurred. The questionnaire includes 20 bipolar statements ranges on a 7 degrees Likert scale (e.g.:, 1 "sad" to 7 "happy"). the statements refers to 2 dimensions: the dimension of the meeting itself ("the current meeting was ...") and the dimension of feeling ("I feel now ...").
Measured: up to 14 months
WAI (working alliance)
To measure alliance at the end of each session, we will use the patient-version of the Session Alliance Inventory. The SAI is a 6-item short-short version of the Working Alliance Inventory. the questionnaire includes 6 items on a scale of 1 ("does not describe how I feel") to 7("exactly describes how I feel").
Measured: up to 14 months
HSCL-11 (symptoms)
The HSCL-11 will be filled by the patient at the beginning of study and thereafter- every two weeks. it includes 11 items on a scale of 1 ("not at all") to 4("a lot").
Measured: up to 14 months
Secondary outcomes (2)
PWB (psychological well-being)
The PWB , filled by the patient at the beginning of study and thereafter- every two weeks, in a commonly used questionnaire assessing psychological well-being with acceptable psychometric properties and convergence with prior indexes of well-being. it includes 54 items ranked on a scale of 1("don't agree") to 6 ("very much agree").
Measured: up to 14 months
Satisfaction from therapy (CSQ)
. The CSQ is a standardized measure with strong psychometric properties that could be used to assess general satisfaction across varied health and human services.
Measured: up to 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start1 Sep 2018 (estimated)
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel, randomized by order, open study, assignment (matching/rematching) supported by monitoring data.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shalvata Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shlomo Mendalovitch, Dr, Principal investigator, Shalvata mental health hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608449
- Sponsor's protocol ID
- SHA-005-18
- Status last verified
- Jul 2018
- First submitted
- 8 Jul 2018
- Last updated
- 1 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doing More With Less": Optimizing Psychotherapeutic Services in the Mental Health System
- ClinicalTrials.gov ID
- NCT03608449
- Acronym / sponsor ID
- SHA-005-18
- Conditions
- Anxiety Disorder, Affective Disorders, Personality Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 1 Aug 2018 (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.
Psychotherapy is one of the cornerstones of mental health services. It is provided by psychiatrist, psychologists and psychiatric social worker in both hospital and out-patient services, and is assumed to require massive manpower and training inputs.
Internationally, the clinical outcomes of routine mental health services are rarely recorded or reported. However, a rough estimation is that half (40-60%) of all psychotherapies have a favorable clinical outcome. Recently (Clark et al, 2017), the English Improving Access to Psychological Therapies (IAPT) Program, which delivers psychotherapies to more than 537 000 patients in the UK each year, indicated that 44% of the patients recovered, and 62%- improved. Consistent with a causal model, most organizational factors also predicted between-year changes in outcome, together accounting for 33% of variance in reliable improvement and 22% for reliable recovery.
The proposed study aims at dramatically improving the yield of psychotherapies in the Mental Health Services by combining monitoring and patient-therapist matching strategies. The first will be achieved by implementing Routine Outcome Monitoring (ROM), and the second- by applying a patient-therapist match-re-match procedure during psychotherapy
Detailed description
Routine Outcome Monitoring Routine Outcome Monitoring (ROM) enables systematic assessment of treatment outcomes at regular intervals for monitoring the progress of patients during treatment. ROM was originally developed for clinical studies, thus providing quality feedback for research and clinical purposes. There is accumulated evidence that ROM has positive effects for supporting care, for research and for management.
As of the beginning of the previous decade, ROM projects have developed and integrated into national health systems (e.g. Australia and New Zealand, England, etc.) and in various research groups around the world (e.g. Holland, Italy, USA, Canada, (Ruggeri, 2002; Burgess et al., 2012; Mellor-Clarket al., 2006) .In recent years, computer software has been widely used to collect, analyze and manage information in a secure, efficient and accessible manner, providing ongoing feedback to caregivers (Barkham et al., 2001; Barkham \& Mellor-Clark, 2003; Margison et al., 2000).
Routine outcome monitoring can enable achieving several goals that directly contribute to treatment (De Beurs et al., 2011). It provides quality feedback to clinicians and patients in real time about the progress of the treatment and the early identification of various problems such as negative response to therapy. This increases the positive response to the treatment, balances the therapist's biases in an optimistic or pessimistic direction, supports decisions in treatment and improves the cooperation between the therapist and the patient. Hence, patients' involvement in the therapeutic process, their commitment to it, and their satisfaction (Whipple \& Lambert, 2011), Lambert, 2010 (Priebe et al., 2002) also improve. A group of studies has shown that frequent monitoring of the evaluation of the therapeutic relationship during psychotherapy enables better real-time identification of therapeutic ruptures that can be corrected (Muran et al. 2009; Safran et al., 2011). In psychiatric work with more severe patients, it was demonstrated that there was a correlation between ROM and a significant reduction in the number and duration of hospitalizations, a finding that has a significant economic significance (Slade et al., 2006). In a meta-analysis review published in 2009 (12 studies, 2001-2006) a significant short-term symptomatic improvement and some long-term improvements was shown in monitored therapies. In another review (Shimokawa et al., 2010), a weekly measure of personal well-being measures had a significant positive impact on the quality, duration and outcome of treatment, especially in patients prone to dropout. Despite initial objections among teams to introduce quantitative measurements into their work, various attempts have shown that after assimilation, staff satisfaction from the systems is great and serves as a complement to individual work and staff meetings (de Beurs et al., 2011).
The collection of the broad information in the ROM is also used for managerial purposes (Trauer, 2010). For example, the accumulated information can be used for ongoing epidemiological research of treatments as they actually occur in a heterogeneous clinical environment and may maximize resources utilization (Coombs et al., 2011). The information produced (on the organizational, local, regional or national levels) is more likely to have higher predictive validity than information extracted from incidental questioning patients for improvement. Effective evaluations of various treatment approaches have also been made, and it is important to consider that treatments are indeed effective in the particular clinical setting they are provided, and not only in controlled studies under very different conditions (Stiles et al., 2008). Applying ROM appears to be more effective when integrated in a formalized and structured manner (Krägeloh, 2015). In such terms, it may be a powerful managerial tool, balancing between the patient's expectations and needs and the mental health care capacity. It is thus surprising, as recently noted by Jensen-Doss (2018), that ROM rarely used in practice, even though it is viewed favorably.
Despite current enthusiasm, advances in implementation, and the growing belief among some proponents and policymakers that ROM represents a major revolution in the practice of psychotherapy, other research has suggested that the focus on measurement and monitoring is in danger of missing the point (Miller et al., 2015). Research from the field of expertise and expert performance provides guidance for realizing the full potential of ROM. One crucial element in optimizing the effect of the ROM is that the decisions derived from continuously collecting the outcome measures will be taken with the patient (and not just shared with him/her). As shown by Clarke et al. (2015), more active involvement in decision-making than the patient stated as desired was associated with higher satisfaction. A clinical orientation towards empowering, rather than shared, decision-making may maximize satisfaction and optimize the effect ROM may have on clinical practice.
Implementation of novel strategies in the field of psychiatry may result in substantial cost reduction (van Londen, 2016) Patient-therapist matching in psychotherapy Research on fitting treatment procedures to the unique needs and proclivities of patients is limited. Traditional research on efficacy of psychotherapy focuses on the role of interventions and theoretical brands, minimizing factors that cannot be randomly assigned. This line of research has not realized its initial and desired promise, perhaps because it fails to incorporate into the study of psychotherapy important and effective treatment variations that are associated with therapist and non-diagnostic patient factors (Beutler, 2015).
The possibility to match patient to therapist by pre-treatment data did not succeed. Many factors were found to contribute to good outcome in psychotherapies. These include patient's factors (e.g.- high levels of motivation and involvement with positive, but realistic attitude), therapist's factors (e.g.- training and supervision) and relational factors (strength of therapeutic alliance is a leading factor; other factors are of moderate- to poor-correlation to outcome) (Cooper, 2008).
While it is accepted that pre-treatment patient-therapist match will not do, the possibility to re-match patient-therapist dyads in case of unsuccessful therapies clinically sounds. Surprisingly, to our best knowledge, this possibility was never examined. Thus, while the ROM clearly indicates whether the trajectory of a given psychotherapy is favorable, it is not examined for initiating patient-therapist re-matching in therapies with poor outcome. This can be attributed to the personal and protected nature of the psychotherapy, generally perceived as indifferent to external observation.
RESEARCH ASSUMPTIONS Co-implementation of patient- and therapist-based routine monitoring tools with matching/re-matching strategies will promote therapy outcome in 25% and will not reduce total patients' satisfaction.
As measured in cost-effectiveness values, our secondary assumption is that co-implementation of monitoring-\&-managing systems will reduce 28% of mental health costs in the unit examined.
STUDY DESIGN The study (see Figure 1 attached at the end of the proposal) will span over 21 months, of which 14 months will be dedicated for assessing the effect of monitoring-\&-matching system in one out-patient intensive mental health facility.
The study will be performed in the Day Care Department (DCD) of the Shalvata Mental Health Center (SMHC). This unit treats patients who suffer from psychiatric disorders but do not require full hospitalization. The DCD is part of the SMHC out-patient network, and admits patients directly from the community (half-way in). The department has a diverse team (30 professionals) of psychiatrists, psychologists, social workers, occupational therapists, expressive therapists and nursing staff, and receives about 10-15 patients each month. The DCD is ideal for testing new therapeutic strategies in the field of psychiatry: it supplies intensive care (thus enabling frequent monitoring of the patient's condition), it operates in large volumes (i.e., can quickly examine proposals for implementing treatment systems), it is backed by sophisticated information systems (Chameleon; an integrated electronic medical record system) and as it is situated "in-between" the hospitalizing and ambulatory systems (it covers both of them).
The proposed study in a pilot study, thus focusing on a relatively small number of participants. Altogether, one hundred patients will be enrolled in the study, randomized-by-order to either the monitored-\&-matched ("re-matched") group, or the treated-as-usual (TAU) group. Enrolled patients of the two groups will be followed for their entire day-care period, or to a period of 3 months (the shorter of the two). Follow up will include in both re-matched and TAU groups formalized (SCID) and an array of self-reported questionnaires (see below). Patients and therapists of the both group will routinely complete ROM questionnaires, as well as mid- and end-term questionnaires evaluating their condition and satisfaction; only patients of the re-matched group will be matched/re-matched (see below).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel, randomized by order, open study, assignment (matching/rematching) supported by monitoring data.
| Arm | Type | Receives |
|---|---|---|
| study group | Active comparator | Other: questionnairesafter monitoring treatment outcomes for 4 weeks, treatment plan or psychotherpist will be changed according to scoring by the director of department. |
| control group | Placebo comparator | Other: questionnairestreatment as usual. treatment counitunes as usual without depending on monitoring treatment outcomes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All enrolled patients must have a mobile phone capable of hosting the ROM-on-mobile system.
- patients with anxiety/ affective (depressive and bi-polar)/ personality disorders
Key exclusion criteria (7 listed)
- Patients exceeding 65 years at their date of admission,
- Patients with impaired Hebrew fluency (difficulties in either reading or writing),
- Evidence of organic brain syndrome or mental retardation,
- Patients with psychotic disorders (e.g. - schizophrenia, delusional disorders)
- Evidence of probable need for hospitalization,
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 |
|---|---|---|
| questionnairesquestionnaire about mental health status during psychotherapy | Other | control group, study group |
Primary outcome
OQ-45 (outcome measure)
Time frame: up to 14 months
is the most commonly-used outcome measure in psychotherapy. It provides both a measure of weekly change on which the feedback to therapists and patients was based and the criterion measure for classification of a patient into an outcome group on a scale of 0 ("never") to 4 ("always")
SEQ (session outcome)
Time frame: up to 14 months
The SEQ-4 validates the WAI-6, and allows the better identification of sessions in which ruptures and repairs occurred. The questionnaire includes 20 bipolar statements ranges on a 7 degrees Likert scale (e.g.:, 1 "sad" to 7 "happy"). the statements refers to 2 dimensions: the dimension of the meeting itself ("the current meeting was ...") and the dimension of feeling ("I feel now ...").
WAI (working alliance)
Time frame: up to 14 months
To measure alliance at the end of each session, we will use the patient-version of the Session Alliance Inventory. The SAI is a 6-item short-short version of the Working Alliance Inventory. the questionnaire includes 6 items on a scale of 1 ("does not describe how I feel") to 7("exactly describes how I feel").
HSCL-11 (symptoms)
Time frame: up to 14 months
The HSCL-11 will be filled by the patient at the beginning of study and thereafter- every two weeks. it includes 11 items on a scale of 1 ("not at all") to 4("a lot").
2 secondary outcomes
PWB (psychological well-being)
Time frame: up to 14 months
Satisfaction from therapy (CSQ)
Time frame: up to 14 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
- Individual participant dataSharing planned: No. no plan
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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.
Shlomo Mendalovitch, Dr principal investigator
Shalvata mental health hospital
Questions about this trial
What is this clinical trial studying?
A study testing questionnaires in people with Anxiety Disorder and Affective Disorders, run by Shalvata Mental Health Center.
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 7 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 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Shlomo Mendalovitch, Dr (+972-9-7478532, mendlovic@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OQ-45 (outcome measure) (time frame: up to 14 months). The study lists 4 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 1 Aug 2018.