'Living life to the fullest'. A randomized controlled trial.|
|- candidate number||9074|
|- NTR Number||NTR2736|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-feb-2011|
|- Secondary IDs||33619 METiGG|
|- Public Title||'Living life to the fullest'. A randomized controlled trial.|
|- Scientific Title||'Living life to the fullest'. A randomized controlled trial investigating the effect of a online intervention based on Acceptance and Commitment Therapy for adults with mild to moderate mood disorders.|
|- hypothesis||The purpose of the study is to conduct a randomised controlled trial with the onlinecourse 'Voluit Leven' as an intervention to study the: |
1. Cost-effectiveness in terms of reduction of psychological symptoms (mood symptoms and disorders);
2. (Cost)effectiveness in terms of decrease in symptoms of anxiety;
3. Effectiveness in terms of improvements in mindfulness, psychological flexibility, agency and positive mental health.
The hypothesis is that:
1. The interventiongroup is superior to a waitinglist comparison group, with unrestricted access to usual care, in terms of cost-effectiveness;
2. The interventiongroup is superior to a minimal intervention comparison group, in terms of clinical outcomes (reduction of psychological symptoms disorders);
3. The interventiongroup is superior to a minimal intervention comparison group, in terms of reduction of symptoms of anxiety, and improvement of psychological flexibility, agency, positive mental health, and mindfulness.
|- Healt Condition(s) or Problem(s) studied||Depression, Mood disorders|
|- Inclusion criteria||Adults of 18 years and older with mild to moderate (symptoms of) mood disorder.|
|- Exclusion criteria||1. Serious psychopathology requiring immediate treatment measured by the M.I.N.I.-Plus and the SDS. The diagnostic interview will be performed by trained employees (under supervision of pdychologists with a BIG registration as a GZ-psychologist). When there is serious psychopathology, the clients will be referred to their general practitioner;|
2. The presence of a moderate to high suicide risk in accordance with the M.I.N.I.-Plus;
3. Recently started on pharmacological treatment, before three months of the research. If so, it is not well deductable if the effects are to be attributed to the intervention or the pharmacological treatment;
4. Currently undergoing psychological (self-help) treatment at a mental health institution;
5. Not enough time for following the training;
6. Inadequat control of the Dutch language (reading or learning problems).
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||30-jan-2011|
|- planned closingdate||30-nov-2013|
|- Target number of participants||195|
|- Interventions||ONLINECOURSE 'VOLUITLEVEN': |
Subjects receive the free onlinecourse "VoluitLeven", based on the book 'Voluit leven' (Bohlmeijer & Hulsbergen, 2009). The onlinecourse consists of nine modules that can be completed in 9 weeks. Because it is a onlinecourse, participants have a total of 12 weeks to complete the program. In module 1, the principles and objectives are introduced. In Module 2 and 3, participants will receive insight and experience that experiential avoidance does not work. In Module 4, 5 and 6 participants exercise with acceptance, mindfulness and cognitive defusion. In module 7 and 8 participants explicit their values and translate them into concrete behavior. Section 9 focuses on the maintaining of the health gains and relapse prevention.
People who are on the waitinglist, do not receive an onlinecourse. They have unlimited access to standard care. So they can use all the care they want, something that is mentioned in the newsletter. The waitinglist group can get the onlinecourse they choose after 6 months (from baseline).
MINIMAL INTERVENTION CONDITION:
The people in the minimal intervention comparison group receive an onlinecourse Expressive writing, where they are to write daily or regularly about negative emotions they have experienced during the day. It will require approximately 15-30 minutes each day to complete the assignments. In addition, they will spend 45 minutes a week on the feedback of the counselors. The diaries are private. The participants can send parts or conclusions of their diaries by mail in respond of the feedback and quetsions of the counselors at the end of the week. Participants can download and print their diaries for their own use.The coaching is identical to the intervention group.
The rationale of this intervention is that people are offered a meaningful but minimal intervention. We expect that mood symptoms will diminish, but to a lesser extent than participants in the onlinecourse "VoluitLeven." Also, we expect no effects on the assumed processes or mediators (psychological flexibility and mindfulness). Finally, we expect that in the long term effects will decrease while the effects of the onlinecourse ' VoluitLeven" will be retained. A similar design in which a comprehensive intervention was compared with a minimal intervention was successfully applied in a study on the effects of life-review (pot et al., 2008).
|- Primary outcome||Reduction of mood symptoms and disorders.
|- Secondary outcome||1. Reduction of symptoms of anxiety, and an improvement of mindfulness, positive mental health, psychological flexibility, agency and mindfulness;|
2. Reduction in costs of disease and health care use.
|- Timepoints||At the beginning of the study there will be an introductory meeting by phone of approximately 30 minutes, for exlusion of serious psychopathology using the M.I.N.I.-Plus and the SDS (Sheehan Disability Scale). Furthermore, subjects are asked to fill in questionnaires at fourtimes, before the randomisation, at 3 months, at 6 months, and at 12 months.
The following validated instruments will be used:
1. Diagnosis: M.I.N.I-Plus;
2. Severity: SDS;
3. Depression: Center for Epidemiologic Studies Depression Scale (CES-D);
4. Anxiety: HADS-A (Hospital Anxiety and Depression Scale - Anxiety);
5. Psychological flexibility: Acceptance and action questionnaire II (AAQ-II);
6. Mindfulness: Five Facet Mindfulness Questionnaire (FFMQ);
7. Positive mental health: Mental Health Continuum – short form (MHC-SF);
8. Quality of Life: EQ (EuroQol);
9. Cost effectiviness: TIC-P (Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness);
10. Growth motivation: GMI (Grotwth Motivation Index);
11. Agency: Self defining memories;
12. Demografic variables: gender, age, education, marital status, cultural background, medication;
13. Remaining: Alcohol (Weekly Recall), Mindfulnesspractice (open question).
1. Baseline (T01) directly before the randomization;
2. Posttest (T1) 3 months after the baseline;
3. Posttest (T2) 6 months after the baseline;
4. Follow-up (T3) 12 months after the baseline.
With exception of the demographic variables (only at baseline T01), the M.I.N.I.-Plus and the TIC-P (not at T1), all instruments will be administered at all four measurement points. Also the waitinglist condition will not have the measurement at follow-up (T3), because by then they have allready recieved the intervention.
|- Trial web site||www.cursusemoties.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Wendy Pots|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. E.T. Bohlmeijer|
|- Sponsor/Initiator ||University of Twente|
(Source(s) of Monetary or Material Support)
|University of Twente|
|- Brief summary||Depression and anxiety disorders are common health problems among adults in the Netherlands. These disorders have a major negative impact on the functioning and quality of life of the patient. Moreover, these disturbances lead to enormous health care costs annually and increased use of health services. Besides treatment, there is more evidence that prevention and early intervention is a cost-effective alternative to decrease the incidence of mental disorders. The main risk factor for developing mental disorders is the presence of moderate depression and anxiety. Indicated prevention en early intervention aims to reduce psychological symptoms and increase psychological flexibility, thus decreasing the risk of mental disorders.
The University of Twente therefore developed a online intervention, "VoluitLeven", for adults with symptoms of mood disorder and mild to moderate mood disorders in the Netherlands. This onlinecourse is based on the principles of Acceptance and Commitment Therapy (ACT) and mindfulness, and can be used as a indicated preventive and early intervention program. The onlinecourse can be worked through in the security of their own home and time, with help of a counselor.
This study there will be an investigation into the effects of the onlinecourse on psychological symptoms, mindfulness, psychological flexibility, positive mental health and cost-effectiveness. The intervention will be compared to a waitinlist controlgroup and a minimal intervention controlgroup.
|- Main changes (audit trail)|
|- RECORD||6-feb-2011 - 14-feb-2011|
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