|- candidate number||27605|
|- NTR Number||NTR6601|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||30-jul-2017|
|- Secondary IDs||U2017/01072/FRO commissie Ethische Toetsing Onderzoek, Open Universiteit|
|- Public Title||Eurythmytherapy and mental health|
|- Scientific Title||Eurythmytherapy and mental health: the effect of eurythmytherapy on self-determination and psychological symptoms|
|- hypothesis||1. The augmentation in scores (t2-t1 and t3-t1) is higher for EYT group than control group on the original complaint controlled for other treatment. |
2. The augmentation in scores is higher for EYT group than control group on self-determination.
3. The decline in scores is higher for EYT group than control group on sleeping problems.
4. The decline in scores is higher for EYT group than control group on psychopathology.
5. If self-determination score augments, psychopathology score will decline in both groups.
6. Self-determination mediates the negative relation between EYT and psychopathology.
7. People within EYT-group who do accomplish their EYT-exercises five or more days a week, have more decrease in psychopathology score, than people who practice less days a week.
8. People within EYT-group who scored low on self-determination at t1 benefit psychologically most from EYT, expressed by highest decrease in psychopathology score.
9. On which diagnoses is EYT most/least effective?
|- Healt Condition(s) or Problem(s) studied||Mental health, Euritmite Therapy (ET)|
|- Inclusion criteria||age 18+|
abel to move reasonably well
|- Exclusion criteria||legally incompetent|
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-sep-2017|
|- planned closingdate||28-feb-2018|
|- Target number of participants||230|
|- Interventions||Eurythmytherapy (EYT) is a specific movement therapy used as complementary therapy or monotherapy. EYT is performed in individual therapy sessions of about 25 to 30 minutes duration one or two times a week. Part of the treatment is the instruction to practice the learned EYT-exercises at home for about 10 minutes a day.|
The intervention group receives ‘treatment as usual’ containing EYT. The control group receives also ‘treatment as usual’ containing no EYT.
Results are measured by questionnaires: t1 (pretest), t2 (posttest) and t3 (follow-up). Completing a questionnaire takes approximately 15 minutes each time.
|- Primary outcome||self-determination (BPNSFS), psychopathology (SQ-48)|
|- Secondary outcome||autonomy satisfaction, competence satisfaction, relatedness satisfaction, sleeping problems, anxiety, social phobia, agoraphobia, depression, somatic complaints, cognitive complaints, aggression, vitality/optimism, work/study|
|- Timepoints||Intervention group: pre-test, post-test, follow-up (1 month).
Control group: pre-test, post-test after 7 or 8 weeks, follow-up (1 month) |
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MA Roelien Logtenberg |
|- CONTACT for SCIENTIFIC QUERIES||MA Roelien Logtenberg |
|- Sponsor/Initiator |
(Source(s) of Monetary or Material Support)
|- Brief summary||The efficacy of eurythmytherapy is measured before and after normal treatment by questionnaire. EYT-clients are compared to people who are indicated for EYT, but choose not to join EYT. The study aims to ameliorate the indication policy for EYT by physicians, physiotherapists and psychologists and to contribute to evidence-bases.|
|- Main changes (audit trail)|
|- RECORD||30-jul-2017 - 20-aug-2017|