The purpose of the study is to conduct a randomized controlled trial with the self-help intervention *Voluit leven* for adults with mild to moderate psychological distress. The research question is: What are the effects of the preventive self-help…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Decreased psychological distress (depression, anxiety)
Secondary outcome
Increased mental health.
Background summary
Many adults in the Netherlands suffer from mental disorders, such as depression
and anxiety. These disorders have a high negative impact on the quality of
life. They also cause high economic costs and increased use of health services.
Besides treatment, there is more evidence that also prevention is a
cost-effective alternative to decrease the incidence of mental disorders.
The University of Twente therefore developed the preventive group intervention
*Voluit Leven*, based on Acceptance and Commitment Therapy for adults with mild
to moderate psychological distress. The group intervention was evaluated in a
randomized controlled trial with 93 adults with psychological distress. The
results showed that the intervention group, compared with a wait list group,
had decreased psychological distress (depression and anxiety), fatigue and had
increased psychological flexibility and mental health.
This intervention is now developed as a self-help book based on Acceptance and
Commitment Therapy and mindfulness, whereby people can work independently
through the book with supportive counselor contact.
Study objective
The purpose of the study is to conduct a randomized controlled trial with the
self-help intervention *Voluit leven* for adults with mild to moderate
psychological distress.
The research question is: What are the effects of the preventive self-help
intervention *Voluit leven* for adults with mild to moderate psychological
distress, based on Acceptance and Commitment Therapy, on psychological
distress, fatigue, mindfulness, psychological flexibility and mental health as
compared to a waitlist group?
Study design
A randomized controlled trial with three parallel groups:
1. Experimental condition: the self-help intervention *Voluit leven* with
process monitoring by a counselor with e-mail contact.
2. Experimental condition: the self-help intervention with process monitoring
and personal support by a counselor with e-mail contact.
3. Control condition: a waitlist group, the participants receive the self-help
intervention after three months.
Intervention
Selp-help intervention with process monitoring by a counselor : The self-help
intervention *Voluit leven* is a book with 9 modules that can be followed in 9
weeks. The intervention is monitored by counselor e-mail contact.
Self-help intervention with process and personal support by a counselor: This
is the same intervention described above, but the counselor provides also more
personal support.
Waitlist group: The participants on the waitlist do not receive the
intervention.
Study burden and risks
Participants have to work about 2 a 4 hours per week in the self-help book.
Thereby, the participants are asked to fill out questionnaires at five moments.
This gives a burden of about 4 hours. We expect not many risks for the
participants, because there are relative healthy population.
Postbus 217
7500 AE, Enschede
NL
Postbus 217
7500 AE, Enschede
NL
Listed location countries
Age
Inclusion criteria
Adults of 18 years and older with mild to moderate psychological distress
Exclusion criteria
1. Serious psychopathology requiring immediate treatment measured with the M.I.N.I
2. Recently started on pharmacological treatment
3. Currently undergoing treatment at a mental health institution
4. Reporting no psychological complaints (a score of 9 or below on the CES-D or a score of 2 or below on the HADS-A) .
5. Not enough time for following the self-help intervention
6. Poor control of the Dutch language (reading or learning difficulties)
7. Not having e-mail address
Design
Recruitment
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 | NL28042.097.09 |