Objective/research question: What are costs and effects of group-oriented Psychiatric Rehabilitation ("Patient and Partner Education Program for All chronic diseases": PPEP4AII) in patients with Persistent Depressive Disorder and their…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary is quality of life (QALYs).
Secondary outcome
Secondary are costs, psychopathology, resilience, disease burden
Background summary
Chronic depression (more than 2 years depressed) is a common psychiatric
disorder which is difficult to treat. Usual care is mostly individual,
including psychopharmacotherapy and/or psychotherapy and psychiatric nurse
guidance. If treatment outcome is insufficient, then psychiatric rehabilitation
is indicated according to the guideline: this project concerns psychiatric
rehabilitation, in which the partner of the patient (or significant other) is
involved in the treatment by means of a partnergroup or individual partner
sessions (PPEP4AII: "Patient and Partner Education Program for All chronic
diseases"). There is clinical evidence for PPEP4All but its cost-effectiveness
has not been investigated yet, which is the aim of the present project. In
mental health care is an urgent need for costeffective and easy-to-implement
treatment protocols for rehabilitation in chronic depression.
Study objective
Objective/research question: What are costs and effects of group-oriented
Psychiatric Rehabilitation ("Patient and Partner Education Program for All
chronic diseases": PPEP4AII) in patients with Persistent Depressive Disorder
and their partner (or significant other), compared to Usual care?
Hypothesis is as follows: Compared to Usual care, PPEP4AII will cost less, lead
to better quality of life/functioning, fewer psychological symptoms, more
resilience, less chronic disease burden.
Study design
Multicenter Pragmatic Randomised Controlled Trial (superiority design).
Intervention
PPEP4AII includes 10 weekly cognitive-behavioral group sessions of
Rehabilitation for patients with a separate partner group. PPEP4All can be
given in a group or in individual one-on-one sessions. In accordance with the
COVID-19 measures, we will ensure that the PPEP4All is offered in a safe
environment, for example, PPEP4All online over video-calling.
Study burden and risks
No risks are involved, and the burden for patients is minimal: 6 brief
questionnaires during 4 assessments (1 year) by the researcher at the 4 mental
health care centres. Assessment time points are as follows: T1/baseline,
T2/posttreatment at 3 months, T3/follow-up at 6 months, T4/follow-up at 12
months. There is no somatic assessment involved, and no somatic or
psychological discomfort is expected.
Albinusdreef 2
Leiden 2300 RC
NL
Albinusdreef 2
Leiden 2300 RC
NL
Listed location countries
Age
Inclusion criteria
chronic depression (> 2 years depressed)
Exclusion criteria
no chronic depression, serious somatic comorbidity and/or psychiatric
comorbidity (such as psychotic or bipolar disorder)
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL59309.058.16 |