Psychotherapy Research and Outcome Measures Clinical Trial
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.
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.
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