In this study we will compare the (cost-) effectiveness on depression of 25- versus 50-sessions of psychotherapy (SPSP or ST) within one year in patients with depression and comorbid personality disorders. In addition we will examine the personality…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
It is unknown what the optimal treatment-dosage is. For depression a recent
meta-analysis showed a strong association between the number of
therapy-sessions per week and treatment outcome. Patients with both depression
and personality disorder(s) are believed to be difficult to treat patients,
accounting for a high psychological and economic burden. 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.
Study objective
In this study we will compare the (cost-) effectiveness on depression of 25-
versus 50-sessions of psychotherapy (SPSP or ST) within one year in patients
with depression and comorbid personality disorders. In addition we will examine
the personality changes that will be achieved in both dosages and we aim to
understand therapeutic processes that account for the differences. Knowing
these factors can further improve treatment effectiveness.
Study design
A mono-center randomized clinical trial with four parallel groups: 1) SPSP-25,
2)SPSP-50, 3)ST-25 and 4) ST-50. After six months session-frequency decreases
by 50% in all groups, from one session a week to one session every two weeks in
the 25-conditions and from two session a week to one a week in the
50-conditions.Randomization on patient level will be pre-stratified according
to severity (BDI-score >= 30 is high severity, BDI-score<29 is low severity).
Intervention
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-weekly sessions of SPSP or ST are
provided during the first six months, followed by once-weekly sessions during
the last six months.
Study burden and risks
Patients will be invited to a clinical screening interview. Part of the other
measurements can be done either online or on paper-and-pencil. At the end of
treatment, at 1 yeear follow up and at 3 years follow up assessments will take
place including a semi-structured interview. A small part of the patients
(N=20) will, in addition be asked to take part in a qualitative interview.
Although the burden includes a time investment of the patient, no risks are
associated with participation in the study.
Domselaerstraat 128
Amsterdam 1093MB
NL
Domselaerstraat 128
Amsterdam 1093MB
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL55916.029.15 |