Optimizing treatment dosage for depression and comorbid personality disorders: a randomized clinical trial

Completed

Conditions: Depression and personality disorders
10027946

Registration Number: NL-OMON50650

Lead Sponsor: Arkin, Amsterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

Age 18-65 years
DSM-IV diagnosis of a major depressive episode or dysthymia and
DSM-IV diagnoses of one or more personality disorders

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 can*t be met
- Use of medication that influences mental functioning: antipsychotics,
moodstabilizers, benzodiazepines > 30mg oxazepam or equivalent per day.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Depression severity (BDI-II) will be the main outcome measure. The proportion<br /><br>of patients that achieve reliable and clinically significant improvement at<br /><br>termination and follow-up will we calculated on the outcome measure (BDI-II)<br /><br>for both conditions, using the method by Jacobson and Truax.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures are personality changes, cost-effectiveness and<br /><br>quality of life. Also process variables will be analysed in order to find<br /><br>change mechanisms in psychotherapy. One of the factor that will be investigated<br /><br>is the working alliance and the level of discourse in SPSP. Moderating factors<br /><br>like the type of therapy will also be analysed.</p><br>