Psychotherapy Research and Outcome MeasuresNCT04017676
Optimizing the Resources of Psychotherapy as a Tool for Implementing the Mental Health Reform
A study testing Supervision assissted by measures in people with Psychotherapy Research and Outcome Measures, run by Shalvata Mental Health Center.
Trial summary
Psychotherapy is one of the cornerstones in public and private mental health services. Despite the tremendous investment in psychotherapy, its efficiency ranges from 40% to 60%. Given the Mental health Reform (2015), aimed at increasing the quality, availability, and accessibility of mental health services, there is… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Psychotherapy Research and Outcome Measures
- What is being tested?
- Supervision assissted by measures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Oct 2020to Apr 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Included are patients over the age of 18 years who have agreed to participate in the study, were found suitable for psychotherapeutic treatment and are treated with the attending clinician for at least two months.
Who cannot join
- Patients who (due to cognitive impairment, language gaps, etc.) are not able to complete questionnaires with little help will not be included in the study. In order to minimize the effect of external variables, patients who, in the opinion of the clinician, are expected to undergo significant pharmacological changes (change in non-sleeping drugs or occasional sedatives) will not be included
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Optimizing the Resources of Psychotherapy as a Tool for Implementing the Mental Health Reform: A Multicenter Controlled Clinical Trial
Psychotherapy is one of the cornerstones in public and private mental health services. Despite the tremendous investment in psychotherapy, its efficiency ranges from 40% to 60%. Given the Mental health Reform (2015), aimed at increasing the quality, availability, and accessibility of mental health services, there is an urgent need to manage and maximize psychotherapy services in Israel.
Read the detailed description
Objectives: To examine the feasibility of implementing managing (monitor and interventional) procedures in psychotherapy services conducted in public mental health services, to assess their effect on the outcome, and to estimate their impact on the 2015 Mental Health Reform objectives.
Working hypotheses:
- After appropriate preparation, managed psychotherapeutic service will be implemented in 4 public mental health out-patients clinics;
- Managed psychotherapeutic service will lead to an improvement in the outcome of psychotherapy;
- Managed psychotherapeutic service will increase the efficacy of mental health services.
Methods:
Type of study: A multicenter, randomized, controlled study with a group comparison and a program trial, in which the subjects are recruited according to a systematic allocation by order.
Since in the field of psychotherapy, "measure means affect," there is a built-in difficulty in building control groups (which are also committed to evaluation). For this reason, the proposed study combines a control group comparison.
Research population: The study will be carried out in the therapeutic settings of two psychiatric hospitals: the Shalvata Mental Health Center and the Geha Mental Health Center. The study population will include patients receiving therapeutic services in the ambulatory system of these centers (three clinics, the Shalvata Mental Health Center, one clinic, the Geha Mental Health Center). The study population includes patients with all the common mental disorders (adjustment disorders, anxiety, depression, personality disorders and somatomorphic disorders). The allocation between caregivers will be random in order, in a one-to-one ratio.
Research groups: The proposed study has two groups. Both groups include patients who are actively receiving psychotherapy on a weekly basis for at least three months to neutralize the effects of starting treatment. The first group will be under the usual treatment conditions (TAU); The second group will be exposed to a multidisciplinary therapeutic program that has a monitoring component and after two months an intervening component will be. In order to reduce the effect of the treated variables and the analysis of nested data, each therapist will introduce two patients into the study: one patient will be in the normal treatment condition (TAU) and the other under the monitoring and intervention program. In order to ensure randomization in this allocation, the clinic manager will determine the identity of the patients (i.e., each therapist will recruit two patients, and the allocation decision will be made anonymously by the clinic manager).
Inclusion criteria: Included are patients over the age of 18 years who have agreed to participate in the study, were found suitable for psychotherapeutic treatment and are treated with the attending clinician for at least two months. Patients who (due to cognitive impairment, language gaps, etc.) are not able to complete questionnaires with little help will not be included in the study. In order to minimize the effect of external variables, patients who, in the opinion of the clinician, are expected to undergo significant pharmacological changes (change in non-sleeping drugs or occasional sedatives) will not be inclusesd Population of caregivers: Experienced therapists from various therapeutic professions (including psychologists, social workers, psychiatrists, and other therapists who are graduates of psychotherapy training programs) will participate in the study. Only therapist who have a proven experience of at least 6 months in the clinic and manage at least four treatments at the beginning of the study will participate.
Data collection: Data collection will be carried out through computerized information systems (computerized medical records, by an application on a cellular device currently being developed as part of the project).
Research tools and variables: The primary outcome measure of the study is the OQ-45 (Lambert, M. J., Gregersen, A.T., Burlingame, G.M. (2004). The Outcome Questionnaire-45 The use of psychological testing for treatment planning and outcomes assessment: Volume 3: Instruments for adults (3rd ed) (pp. 191-234). Mahwah, NJ, US: Lawrence Erlbaum Associates Publishers).
Methods of data analysis: Differences between groups will be examined using chi-squared tests (in categorical variables) or by independent T-tests and Mann-Whitney tests (non-categorical variables). Time differences will be analyzed by ANCOVA (repeated measures) and TSA (time series analysis). The sample size estimation is 68 patients.
Importance: Managed psychotherapeutic service has the potential to improve the clinical outcomes, and to increase the efficiency of the mental health services following the goals of the 2015 Mental Health Reform.
- Being tested
- Supervision assissted by measures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervision assissted by measuresOther
In the weeks 10 and 13, about 72 hours after the meeting scheduled for that week, and before the next therapeutic session, there will be a structured training session (based on the recommendations of Krägeloh et al., 2015), based on information in the literature about the various questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The first group will be under the usual treatment conditions (TAU) |
| Experimental group | Experimental | The second group will be exposed to a multidisciplinary therapeutic program that has a monitoring component and after two months an intervening component will be. Receives: Other: Supervision assissted by measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in OQ45
The primary outcome measure of the study is the OQ-45 (Lambert, M. J., Gregersen, A.T., Burlingame, G.M. (2004). The Outcome Questionnaire-45 The use of psychological testing for treatment planning and outcomes assessment: Volume 3: Instruments for adults (3rd ed) (pp. 191-234). Mahwah, NJ, US: Lawrence Erlbaum Associates Publishers).
Measured: Initiation, Week 4, Week 7, Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study startOct 2020 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotherapy Research and Outcome MeasuresStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multicenter, randomized, controlled study with a group comparison and a program trial, in which the subjects are recruited according to a systematic allocation by order.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shalvata Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Geha Mental Health Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017676
- Sponsor's protocol ID
- Sha0006-19
- Status last verified
- Jul 2019
- First submitted
- 9 Jul 2019
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Resources of Psychotherapy as a Tool for Implementing the Mental Health Reform: A Multicenter Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04017676
- Acronym / sponsor ID
- Sha0006-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Collaborators
- Geha Mental Health Center
- Study start
- Oct 2020 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 12 Jul 2019 (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 in public and private mental health services. Despite the tremendous investment in psychotherapy, its efficiency ranges from 40% to 60%. Given the Mental health Reform (2015), aimed at increasing the quality, availability, and accessibility of mental health services, there is an urgent need to manage and maximize psychotherapy services in Israel.
Detailed description
Objectives: To examine the feasibility of implementing managing (monitor and interventional) procedures in psychotherapy services conducted in public mental health services, to assess their effect on the outcome, and to estimate their impact on the 2015 Mental Health Reform objectives.
Working hypotheses:
- After appropriate preparation, managed psychotherapeutic service will be implemented in 4 public mental health out-patients clinics;
- Managed psychotherapeutic service will lead to an improvement in the outcome of psychotherapy;
- Managed psychotherapeutic service will increase the efficacy of mental health services.
Methods:
Type of study: A multicenter, randomized, controlled study with a group comparison and a program trial, in which the subjects are recruited according to a systematic allocation by order.
Since in the field of psychotherapy, "measure means affect," there is a built-in difficulty in building control groups (which are also committed to evaluation). For this reason, the proposed study combines a control group comparison.
Research population: The study will be carried out in the therapeutic settings of two psychiatric hospitals: the Shalvata Mental Health Center and the Geha Mental Health Center. The study population will include patients receiving therapeutic services in the ambulatory system of these centers (three clinics, the Shalvata Mental Health Center, one clinic, the Geha Mental Health Center). The study population includes patients with all the common mental disorders (adjustment disorders, anxiety, depression, personality disorders and somatomorphic disorders). The allocation between caregivers will be random in order, in a one-to-one ratio.
Research groups: The proposed study has two groups. Both groups include patients who are actively receiving psychotherapy on a weekly basis for at least three months to neutralize the effects of starting treatment. The first group will be under the usual treatment conditions (TAU); The second group will be exposed to a multidisciplinary therapeutic program that has a monitoring component and after two months an intervening component will be. In order to reduce the effect of the treated variables and the analysis of nested data, each therapist will introduce two patients into the study: one patient will be in the normal treatment condition (TAU) and the other under the monitoring and intervention program. In order to ensure randomization in this allocation, the clinic manager will determine the identity of the patients (i.e., each therapist will recruit two patients, and the allocation decision will be made anonymously by the clinic manager).
Inclusion criteria: Included are patients over the age of 18 years who have agreed to participate in the study, were found suitable for psychotherapeutic treatment and are treated with the attending clinician for at least two months. Patients who (due to cognitive impairment, language gaps, etc.) are not able to complete questionnaires with little help will not be included in the study. In order to minimize the effect of external variables, patients who, in the opinion of the clinician, are expected to undergo significant pharmacological changes (change in non-sleeping drugs or occasional sedatives) will not be inclusesd Population of caregivers: Experienced therapists from various therapeutic professions (including psychologists, social workers, psychiatrists, and other therapists who are graduates of psychotherapy training programs) will participate in the study. Only therapist who have a proven experience of at least 6 months in the clinic and manage at least four treatments at the beginning of the study will participate.
Data collection: Data collection will be carried out through computerized information systems (computerized medical records, by an application on a cellular device currently being developed as part of the project).
Research tools and variables: The primary outcome measure of the study is the OQ-45 (Lambert, M. J., Gregersen, A.T., Burlingame, G.M. (2004). The Outcome Questionnaire-45 The use of psychological testing for treatment planning and outcomes assessment: Volume 3: Instruments for adults (3rd ed) (pp. 191-234). Mahwah, NJ, US: Lawrence Erlbaum Associates Publishers).
Methods of data analysis: Differences between groups will be examined using chi-squared tests (in categorical variables) or by independent T-tests and Mann-Whitney tests (non-categorical variables). Time differences will be analyzed by ANCOVA (repeated measures) and TSA (time series analysis). The sample size estimation is 68 patients.
Importance: Managed psychotherapeutic service has the potential to improve the clinical outcomes, and to increase the efficiency of the mental health services following the goals of the 2015 Mental Health Reform.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A multicenter, randomized, controlled study with a group comparison and a program trial, in which the subjects are recruited according to a systematic allocation by order.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The first group will be under the usual treatment conditions (TAU) |
| Experimental group | Experimental | Other: Supervision assissted by measuresThe second group will be exposed to a multidisciplinary therapeutic program that has a monitoring component and after two months an intervening component will be. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Included are patients over the age of 18 years who have agreed to participate in the study, were found suitable for psychotherapeutic treatment and are treated with the attending clinician for at least two months.
Key exclusion criteria (1 listed)
- Patients who (due to cognitive impairment, language gaps, etc.) are not able to complete questionnaires with little help will not be included in the study. In order to minimize the effect of external variables, patients who, in the opinion of the clinician, are expected to undergo significant pharmacological changes (change in non-sleeping drugs or occasional sedatives) will not be included
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 |
|---|---|---|
| Supervision assissted by measuresIn the weeks 10 and 13, about 72 hours after the meeting scheduled for that week, and before the next therapeutic session, there will be a structured training session (based on the recommendations of Krägeloh et al., 2015), based on information in the literature about the various questionnaires | Other | Experimental group |
Primary outcome
Change in OQ45
Time frame: Initiation, Week 4, Week 7, Week 20
The primary outcome measure of the study is the OQ-45 (Lambert, M. J., Gregersen, A.T., Burlingame, G.M. (2004). The Outcome Questionnaire-45 The use of psychological testing for treatment planning and outcomes assessment: Volume 3: Instruments for adults (3rd ed) (pp. 191-234). Mahwah, NJ, US: Lawrence Erlbaum Associates Publishers).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Supervision assissted by measures in people with Psychotherapy Research and Outcome Measures, 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 1 inclusion and 1 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 12 Jul 2019. 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. 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 Mendlovic, MD (972-50-6770178, mendlovic@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in OQ45 (time frame: Initiation, Week 4, Week 7, Week 20). 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 12 Jul 2019.