|- candidate number||10601|
|- NTR Number||NTR3168|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||30-nov-2011|
|- Secondary IDs|| |
|- Public Title||Outcome of client feedback in treatment of psychiatric patients after a crisis.|
|- Scientific Title||Outcome of client feedback in treatment of psychiatric patients after a crisis.|
|- hypothesis||Compared to treatment as usual adding direct session feedback in the treatment of a mixed diagnostic group of patients in an acute psychiatric crises improves outcome at symptom level, well being, patients’ satisfaction, and drop out.|
|- Healt Condition(s) or Problem(s) studied||Psychiatric patients, Crisis|
|- Inclusion criteria||All patients referred for acute psychiatric crisis treatment to an institution were included in the study. There are no specific inclusion of exclusion criteria at registration.|
|- Exclusion criteria||Patients will be excluded if they have inadequate mastery of the Dutch language.|
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2009|
|- planned closingdate||1-okt-2014|
|- Target number of participants||185|
|- Interventions||Patients will be randomly assigned to two conditions, treatment as usual without feedback, and treatment as usual with direct feedback in each session. All therapists operate in both conditions and apply both treatments.
Treatment as usual:
Treatment as usual consists of acute crisis intervention with brief follow up treatment. The intervention is based on an integrated model emphasizing psychiatric, and systemic therapeutically interventions. This approach is described in the ‘Praktijkboek Crisisinterventie’ (van Oenen et al., 2007). Patients in both trial arms receive treatment as usual.
Direct feedback is based on the Partners for Change Outcome Measurement System (PCOMS) developed by Duncan and Miller ( 2004; Hubble et al, 1999).
The key component of the PCOMS is visualization of the therapeutic alliance and changes in patient’s well being (outcome). For this purpose the PCOMS uses two brief questionnaires, the ‘Outcome Rating Scale’ (ORS) and the ‘Session Rating Scale’ (SRS) designed to assess feedback regarding alliance and treatment effects.
Patients in the experimental condition will be asked to fill in the ORS before each session. Results will be displayed together with scores of the previous sessions, and discussed with the therapist at the beginning of each session. At the end of each session, patients will be asked to fill in the SRS followed by a brief discussion on the patient’s evaluation of the session.
Patients in the experimental trial arm will receive treatment as usual in combination with direct feedback.
|- Primary outcome||The Brief Symptom Inventory (BSI): Is the abbreviated version of the Symptom Checklist 90, consisting of 53 thesis. De BSI is a self-report questionnaire for measuring psychopathological symptoms in adults. The results lead to an overall score and three subscales: Global Severity Index (GSI), Positive Symptom Distress Index (PSDI), and Positive Symptom Total (PST). De Primary outcome: GSI after 3 months. |
|- Secondary outcome||1. The Outcome Questionnaire 45 (OQ-45 ). Scores on the whole scale are used as well as scores on each of three subscales, assessing Symptom Distress (SD), Social-Role functioning (SR) and Interpersonal Relationships (IR);|
2. The Helping Alliance Questionnaire (HAQ-II) is used as indicator of the quality of the working alliance between client and clinician;
3. The Global Clinical Impression (CGI) is used as indicator of global severity of patient’s problem, and global change compared to the beginning of treatment;
4. The ‘Tevredenheidslijst’ is used as indicator of patient’s satisfaction after treatment;
5. The ‘Attitudelijst’ (Morton Anker, in 2005) is used as indicator of clinicians attitude regarding the PCOMS-instrument (de ORS en SRS).
|- Timepoints||Baseline measurements will be conducted after randomization and follow-up measurements will be conducted 6, 12, 18 and 24 weeks after the baseline measurement. Furthermore there will be a follow-up measurement 12 weeks after ending therapy.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Prof.dr. J. Dekker|
|- CONTACT for SCIENTIFIC QUERIES||Prof.dr. J. Dekker|
|- Sponsor/Initiator ||Vrije Universiteit Amsterdam, Arkin Institute for Mental Health|
(Source(s) of Monetary or Material Support)
|- Brief summary||Background:|
Research data strongly suggest that using client feedback can improve patient outcome. This study examines the effect of direct client feedback according to the Partners for Change Outcome Management System (PCOMS). Up to now, PCOMS has only been studied in students and partner counseling.
The primary objective of this study is to examine whether direct feedback results in better treatment outcome in psychiatric patients after acute crisis. The influence of direct feedback on the quality of working alliance is also examined as well as the influence on motivation/attitude of the clinician regarding CDOI to treatment outcomes.
To be able to test the hypothesises all patients that receive help in a two year period from the Crisis team will be followed up during treatment, with a maximum of a 6 months period and 3 months after ending the treatment. Patients will be randomly assigned to two conditions; 1. treatment as usual without feedback and b. treatment as usual with direct feedback. An estimated total of 150 patients, aged 18 years and over will be included in the study.
Sample size calculation/data analysis:
With two groups of 90 patients, an alpha of 0.05 (one-tailed), an effect size of about 0.3 on the Global Severity Index at 12 weeks (mean Exp group=1,0; mean Tau=1,3; Standard deviation at week 12 is 0,80) can be detected with a statistical power of 80%. Analysis will be performed according to the intention to treat principle.
Aim of this study is to examine the effects of systematically obtaining patient feedback during therapy on course and outcome. In addition, we will examine to what extend these effects are influenced by the quality of the working alliance, and clinicians attitude towards this method.
|- Main changes (audit trail)|
|- RECORD||30-nov-2011 - 17-dec-2011|