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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50650
Enrollment
200
Registered
2016-03-09
Start date
2016-04-20
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression and personality disorders

Interventions

In the standard condition once-weekly sessions of SPSP or ST are provided during the first six months, followed by fort-nightly sessions in the last six months. In the experimental condition twice-w

Sponsors

Arkin, Amsterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)