|- candidate number||24670|
|- NTR Number||NTR5941|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||20-jul-2016|
|- Secondary IDs||NL55916.029.15 METc VUmc|
|- Public Title||Optimising treatment dosage for depression and comorbid personality disorders|
|- Scientific Title||Optimising treatment dosage for depression and comorbid personality disorders: a randomized clinical trial|
|- hypothesis||1. We expect the ST/SPSP-50 condition to be more effective than ST/SPSP-25 condition on depression outcome and/or characterological symptoms. |
2. No differences in outcome are expected between ST en SPSP and we donít expect the type of treatment to have a moderating effect on the relation between therapy-dosage and outcome.
|- Healt Condition(s) or Problem(s) studied||Depression, Personality disorder|
|- Inclusion criteria||- Age 18-65 years|
- DSM-IV diagnosis of a major depressive episode or dysthymia
- DSM-IV diagnoses of one or more personality disorders (including PD NOS)
- A written informed consent
|- Exclusion criteria||- Non-Dutch speakers/readers|
- Psychotic symptoms, bipolar disorder or current extreme substance dependence.
- Immediate intensive treatment or hospitalization is needed, e.g. acute suicidality.
- Pregnancy or other reasons why trial demands canít be met
- Use of medication that influences mental functioning: antipsychotics, mood stabilizers, benzodiazepines > 30mg oxazepam or equivalent per day.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2016|
|- planned closingdate||1-mei-2021|
|- Target number of participants||200|
|- Interventions||- Schematherapy 25 sessions (control group)|
- Schematherapy 50 sessions (experimental condition)
- Short term psychodynamic supportive psychotherapy 25 sessions (control group)
- Short term psychodynamic supportive psychotherapy 50 sessions (experimental condition)
|- Primary outcome||Depression severity (BDI-II) and diagnoses (MINI) at end of treatment and at 1 year follow-up|
|- Secondary outcome||Personality parameters (SCID-II, SIPP, YSQ, SMI, DPI), Treatment condition: ST or SPSP), cost evaluation from a societal perspective (Tic-P, EQ-5D, happiness item).|
|- Timepoints||T0=baseline: primary + secondary outcomemeasures|
T1=1mth primary outcomemeasures
T2=2mth primary outcomemeasures
T3=3mth primary outcomemeasures
T4=6mth primary + selection of secondary outcomemeasures
T5= END (9-12 mths) primary + secondary outcomemeasures
T6=Follow up (END+12mths): primary + secondary outcomemeasures
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. A.M. Kool|
|- CONTACT for SCIENTIFIC QUERIES||Drs. A.M. Kool|
|- Sponsor/Initiator ||NPI/Arkin|
(Source(s) of Monetary or Material Support)
|- Brief summary||Background: Patients with both depression and personality disorders are difficult to treat patients, accounting for a high psychological and economic burden. Little is known about the optimal treatment dosage for this particular group. Finding the optimal treatment-dosage for these patients and understanding the processes that account for the therapeutic changes can lead to both higher treatment efficacy and lower costs. |
Methods/Design: The study is a mono-center double-randomized clinical trial. Patients seeking therapy at a Dutch mental health care institute for personality disorders who meet criteria for depression/dysthymia and personality disorder(s) are randomized over therapy-dosage (25 vs 50 sessions) and type of therapy (schematherapy vs short-term psychodynamic psychotherapy). Randomization on patient level will be pre-stratified according to depression severity. The trial is designed to include 200 patients. The primary clinical outcome measure will be depression severity.
Secondary clinical outcome measures will include measures of personality changes, costs from a societal perspective, type of therapy, process measures and quality of life. All patients are assessed at baseline and at 1, 2, 3, 6 months, at the end of therapy (9-12 months) and at one year follow-up.
Discussion: This trial will compare two psychotherapy dosages (25 vs 50 sessions) in patients with both depression and personality disorders. Finding the optimal treatment-dosage for these patients and understanding the processes that account for the therapeutic changes will lead to both higher treatment efficacy and lower costs.
|- Main changes (audit trail)|
|- RECORD||20-jul-2016 - 23-aug-2016|