|- candidate number||21897|
|- NTR Number||NTR5128|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-apr-2015|
|- Secondary IDs||NL 50778 044 15 |
|- Public Title||Well-being therapy in outpatients with mild affective disorders|
|- Scientific Title||A pilot study concerning the effectiveness and practice of well-being therapy in the treatment of outpatients with
a mild anxiety disorder or a mild depression|
|- hypothesis||Firstly this study tries to answer the question whether applying well-being therapy to outpatients with a mild affective disorder in Dutch mental health care, reveals a trend in which well-being is increased and psychiatric complaints are reduced.
Secondly the intention is to learn more about the experiences of the participants (patients as well as therapists) with this new form of therapy, to be able to carry out further development and adjustments if necessary.
The outcome of this study can be used to account for a randomized controlled trail.
|- Healt Condition(s) or Problem(s) studied||Anxiety disorders, Depression, Therapy, Well-being|
|- Inclusion criteria||-Classification according to DSM IV-TR of an anxiety or affective disorder as follows from an intake.|
-Participants are indicated for the 'middle' category in mental health care.
-A below average score (<2.13) on the Mental Health ContinuŁm-Short Form (MHC- SF) before treatment. (this cut off score was based on the mean minus one SD (Lamers et al., 2011) and the expectation that clients with a higher score will have less possibilities for measurable improvements.
-Age between 18 and 65 years.
|- Exclusion criteria||- Poor Dutch language.|
- Complex psychiatric problems which requires special mental health care.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2015|
|- planned closingdate||1-jun-2016|
|- Target number of participants||33|
|- Interventions||Participants will be treated with well-being therapy, a short-term protocol (6 sessions) in which they will actively focus on the enhancement of well-being. |
|- Primary outcome||Well-being, as measured with the Mental Health Continuum-Short Form (MHC-SF).
Psychological complaints as measured with the Hospital Anxiety and Depression Scale (HADS).|
|- Secondary outcome||The experience of patients and therapists with well-being therapy.|
|- Timepoints||Participants will be treated with well-being therapy. They will be asked to answer two questionnaires at three specific moments (T0, T1, T2). In total participants will spend a maximum of 75 minutes on the questionnaires over a period of 6 months. Also, one in three participants will randomly be invited to participate in a semi-structured interview.|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Drs. E.J.B. Peeneman|
|- CONTACT for SCIENTIFIC QUERIES||Msc. L.C.A. Christenhusz|
|- Sponsor/Initiator ||Dimence|
(Source(s) of Monetary or Material Support)
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||1-apr-2015 - 1-jul-2015|