|- candidate number||27601|
|- NTR Number||NTR6621|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||28-jul-2017|
|- Secondary IDs||Grant number 843001706 ZonMw |
|- Public Title||Group psychotherapy for older adults with personality disorders: effectiveness and costs|
|- Scientific Title||Group schema-focused therapy enriched with psychomotor therapy for older adults with personality disorders in specialized mental health care: A (cost-) effectiveness study|
|- hypothesis||Group schema-focused therapy for older adults with personality disorders is cost-effective and superior to treatment as usual in reducing psychological distress and improving quality of life|
|- Healt Condition(s) or Problem(s) studied||Mental problems, Personality disorder|
|- Inclusion criteria||- Age 60 years or older. |
- Cluster B or C personality or meeting the general diagnostic criteria for a personality disorder falling short one content criterion for a specific cluster B or C personality disorder.
- Mentally able to adhere to the group schema-focused treatment schedule and to fill out schema (mode) questionnaires.
- Informed consent after having received oral and written information.
|- Exclusion criteria||- Severe mental illness, including current bipolar disorder, psychosis, or substance abuse disorders needing clinical detoxification.|
- An established neurodegenerative disorder.
- Cognitive impairment defined as a MoCA sum score below 24 points.
- Prior schema-focused therapy, received in the previous year or during the present episode of illness.
- Immediate suicide risk interfering with adequate treatment delivery.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-aug-2017|
|- planned closingdate||31-dec-2019|
|- Target number of participants||140|
|- Interventions||Group Schema Focused Therapy enriched with psychomotor therapy will be delivered in eighteen weekly and two follow-up sessions (at weeks 22 and 26), consisting of 2h group Schema Focused Therapy and 1h psychomotor therapy. Group Schema Focused Therapy focusses on the cognitive behavioural techniques of schema therapy. To overcome the limitations of a purely verbal therapy, psychomotor therapy is added, in which physical exercises are set up to facilitate the experience of patients’ typical cognitions and behaviours. For the control group, treatment as usual is unrestricted.|
|- Primary outcome||Primary outcome is psychological distress, as assessed with the Brief Symptom Inventory- 53 item version (BSI-53).
For cost-effectiveness analysis, health related quality of life is assessed with the EuroQoL; EQ-5D-5L, and medical consumption and other cost data are gathered by structured patient interview. |
|- Secondary outcome||Secondary outcome measures are: 1) life satisfaction, 2) mental wellbeing, 3) personality functioning, 4) interoceptive body awareness, 5) psychotropic drug use and treatment received, and 6) mood variability.|
|- Timepoints||All outcomes are assessed in both study groups at baseline (start of treatment for experimental group), 6 months (end of treatment for experimental group) and 12 and 18 months.|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MSc M.S. Veenstra|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. R.C. Oude Voshaar|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG), Department of Psychiatry|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, Health Care Efficiency Research Programme|
|- Publications||Van Alphen SP, van Dijk SD, Videler AC, Rossi G, Dierckx E, Bouckaert F, Oude Voshaar RC. Personality disorders in older adults: emerging research issues. Curr Psychiatr Rep 2015;17:538.|
Videler AC, Rossi G, Schoevaars M, van der Feltz-Cornelis CM, van Alphen S. Effects of schema group therapy in older outpatients: a proof of concept study. Int Psychogeriatr 2014;26:1709-1717
|- Brief summary||Rationale: The disease burden due to personality disorders is high for patients (lowered quality of life, high levels of psychological distress) and society (increased medical consumption and informal care). A personality disorder is found in more than one third of geriatric psychiatric outpatients, and presence of a comorbid personality disorder worsens treatment outcome for affective disorders. For long, personality disorders were considered treatment resistant, but the past decades several psychological therapies – including schema-focused therapy - have been proven successful. However, personality disorders often remain undiagnosed in geriatric psychiatry, and specific treatment for personality disorders is often not available. Patients are therefore commonly offered treatment for symptoms of depression, anxiety or somatization, leaving their underlying personality pathology untreated.|
Objective: To study the (cost-)effectiveness of group schema-focused therapy enriched with psychomotor therapy in specialized mental health care for older adults. It is hypothesized that this therapy is cost-effective and superior to treatment as usual in reducing psychological distress and improving quality of life.
Study design: A multicenter, randomized trial, with one-year follow-up, comparing the treatment effect of group schema-focused therapy enriched with psychomotor therapy to that of treatment as usual.
Study population: Older persons (60 years or older) with a cluster B or C personality disorder or meeting the general criteria for a personality disorder, who are treated in specialized mental health care.
Intervention (if applicable):Twenty sessions of group schema-focused therapy enriched with psychomotor therapy delivered in groups of 4 through 8 older patients over a 6-month period.
Main study parameters/endpoints: Primary outcome is general psychological distress (Brief Symptom Inventory; BSI-53). Cost-effectiveness analysis will be performed from a societal perspective (based on EQ-5D-5L and structured cost-interviews).
|- Main changes (audit trail)|
|- RECORD||28-jul-2017 - 20-aug-2017|