Primary ObjectiveThe primary objective of this study is to evaluate how effective the intervention Happiness route is in promoting positive mental health in comparison to a control condition that consists of optimized care-as-usual. This objective…
ID
Source
Brief title
Condition
- Lifestyle issues
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Positive mental health is the primary outcome. It is measured with the Dutch
Mental Health Continuum - Short Form (MHC-SF; Lamers, Westerhof, ten Klooster,
Bohlmeijer, & Keyes, 2011; Lamers, Glas, Westerhof & Bohlmeijer, 2012;
Westerhof & Keyes, 2008). The MHC-SF is a 14-item questionnaire that measures
three core dimensions of positive mental health (Keyes, 2002) that also match
the three dimensions of the definition of the World health Organization (2004):
emotional well-being (3 items), psychological well-being (6 items), and social
well-being (5 items). Participants are asked to rate the frequency of feelings
they have experienced in the past month. Items are scored on a 6-point scale
ranging from *never* to *every day. Higher scores indicate better well-being.
The instrument has good psychometric properties (Lamers, Westerhof, ten
Klooster, Bohlmeijer, & Keyes, 2011; Lamers, Glas, Westerhof & Bohlmeijer,
2012; Westerhof & Keyes, 2008) and is sensitive to change (Fledderus,
Bohlmeijer, Smit & Westerhof, 2010; Korte, Bohlmeijer, Cappeliez, Smit, &
Westerhof, 2011).
Secondary outcome
The following well-validated instruments will be used to measure secondary
outcomes:
Loneliness: the eleven-item loneliness scale developed by De Jong Gierveld and
Van Tilburg (1999);
Depression: the Dutch version of the Center for Epidemiological
Studies-Depression Scale (CES-D; Radloff, 1977, Bouma et al., 1995);
Consumption of care: items from the TIC-P (Hakkaart-van Roijen et al., 2002).
Vektis, the Dutch information centre for care, will compare the use of health
care between the experimental and control group;
Purpose in life: the purpose in life scale developed by Ryff (1989; Ryff &
Keyes; 1995);
Resilience: Dutch Resilience Scale (Wagnild & Young, 1993; Portzky et al.,
2010);
Social participation: items that assess (volunteering) work, social contacts
and activities, derived from several nationally representative surveys, such as
CBS-POLS and LISS.
Health-related quality of life: The Dutch version of the EuroQol EQ5D (Brooks,
1996);
Background summary
Social relevance
The Dutch welfare state focuses traditionally on the support of people in
solving their problems. However, there is a group of citizens who keep falling
back on state support. This asks for a new approach that focuses on promoting
positive mental health, i.e. happiness, self-realization and social integration
(WHO, 2005). This is acknowledged in social work (VWS, 2010; VNG, 2010) as well
as in public health (Raad voor de Volksgezondheid en Zorg, 2010). The
*Happiness Route* provides a short behavioral intervention to promote positive
mental health. It uses an outreaching approach to recruit participants and
encourage them to carry out an intrinsically motivating activity for which they
receive a one-time budget (maximum ¤500,-).
Scientific relevance
The Happiness Route is based on recent economic theories (*nudging*) and
psychological theories (*positive psychology*). The economic theory proposes
that it is important to provide citizens a *nudge*, i.e., a gentle push in the
right direction (Thaler & Sunstein, 2008; Tiemeijer, Thomas & Prats, 2009).
Whereas the default nudge in the Dutch system is *What is your problem?*., the
Happiness Route, provides the nudge: *What do you want to do in life?*. This
nudge is based on insights from positive psychology that focus on the promotion
of mental health. Meta-analyses show that the promotion of mental health will
lead to considerable health gains for the individual and society (Chida &
Steptoe, 2008; Howell, Kern & Lyubomirsky, 2007; Lamers, Bolier, Westerhof,
Smit & Bohlmeijer, 2011; Lyubomirksy, King & Diener, 2005; Pressman & Cohen,
2005). Experimental studies have shown that it is possible to increase positive
mental health through behavioral interventions (Bolier, Haverman, Westerhof,
Riper, Smit & Bohlmeijer, under review; Sin & Lyubomirksy, 2009). As there is
an abundance of studies showing that engagement in goal-directed activities is
important for positive mental health (Westerhof & Bohlmeijer, 2010 provide an
overview), the Happiness Route stimulates intrinsic goal engagement through the
positive *nudge*.
Selected population
The intervention aims at a group that experiences an accumulation of risk
factors for a low positive mental health: lower socioeconomic status, social
isolation, and health limitations (Diener, Suh, Lucas & Smith, 1999; Veenhoven,
1996; Walburg, 2008; Westerhof & Keyes, 2010).
New information added by the study
Existing studies on positive psychological interventions were small, carried
out in experimental settings, and with rather privileged groups. The present
study will belong to the 10% largest trials on positive psychological
interventions (Sin & Lyubomirsky, 2009). It is among the first to examine such
an intervention in a practice-based research setting with several partners in
the field of social work. Our study is also among the first to target
individuals with an accumulation of risk factors for low levels of mental
health (low SES, social isolation and health problems). It will thus provide
new insights in the possibilities for mental health promotion in a naturalistic
setting.
Study objective
Primary Objective
The primary objective of this study is to evaluate how effective the
intervention Happiness route is in promoting positive mental health in
comparison to a control condition that consists of optimized care-as-usual.
This objective contributes to our knowledge on the promotion of positive mental
health in a practice-based research setting.
Secondary Objectives
There are four secondary objectives:
1. How effective is the intervention Happiness route in comparison to the
control condition in terms of decreasing loneliness, depression, and
consumption of care and in increasing purpose in life, resilience, social
participation, and health related quality of life?
2. Is the effect of the intervention different for participants with different
characteristics (age, gender, and cultural background)?
3. Is the effect of the intervention different for counselors with different
characteristics (work experience, work satisfaction, and adherence to the
intervention programme)?
4. How is the intervention evaluated by counselors and participants?
Study design
Design
A multi-centered randomized controlled trial will be carried out with two
parallel groups:
1. Experimental condition: the Happiness Route.
2. Control condition: Optimized care-as-usual.
The experimental condition in this study will be compared to the control
condition. The trial is practice-based and pragmatic in that we study the
effects in a naturalistic setting. As we want to compare the Happiness Route
intervention with care-as-usual, two home visits from a professional will make
sure that the care the participants in the control group receive is optimal.
Instruments
Participants will fill out questionnaires at three measurement points: during
the intake, 3 months and 9 months later. They need about 45 minutes to fill out
the questionnaire at each of these measurement points.
Counselors will fill out a questionnaire after their training. This will take
about 20 minutes to complete. Furthermore, counselors will fill out a log file
for each participant after each session. This will take about 15 minutes per
session.
Setting
The study will be carried out in the field of social work and care in ten
municipalities in the Netherlands. The municipalities cooperate under
responsibility of the alderman of welfare and care (wethouder welzijn en zorg).
A municipal officer who is under direction of the alderman will be the local
project leader. The recruitment of participants is done by intermediaries who
work in local institutions in social work and care. Trained counselors are
responsible for the intake and the delivery of interventions. The intervention
and the study will be carried out at the homes of the participants.
Intervention
Experimental condition: Happiness Route
The intervention builds on the existing intervention Happiness Route (Toolkit
Geluksbudget, 2008) but is formalized and strengthened with the help of
existing intervention methods in positive psychology. The intervention consists
of five stages: (1) mutual definition of the situation by the participant and
counselor based on the findings from the intake, (2) goal orientation, (3)
choice of an activity, (4) planning and carrying out the activity, and (5)
early evaluation and feedback in a *booster* session. The counselor will make
use of evidence-based methods during each phase. between two and five sessions
will take place at the home of the participant, with a maximum of 1,5 hours per
session. The stages are flexibly divided over the number of sessions. The whole
process is completed within three months, before the second questionnaire will
be filled in.
Control condition: Home Visiting Program
After the intake, participants receive two home visits to make sure that
participants are provided with the best possible care as usual.
Study burden and risks
Participation in the study is not expected to have any risks. The predecessor
to the behavioral experimental intervention *Happiness Route* (Geluksbudget)
has been delivered to more than 400 adults without any negative effects.
Participation is voluntary. There is only a very minor burden for participants
in filling out three questionnaires. This will take about 45 minutes at each of
the three measurement occasions.
Drienerlolaan 5 5
Enschede 7522 NB
NL
Drienerlolaan 5 5
Enschede 7522 NB
NL
Listed location countries
Age
Inclusion criteria
- Age: >= 18 years
- Social isolation: a score of 3 or higher on the loneliness scale (de Jong Gierveld & Van Tilburg, 1999)
- Low socioeconomic status: a low educational level (VMBO/LBO/MULO/MAVO or less) or few financial means (we use the CBS budget approach which includes income for basic means as well as participation, i.e., 1.000euro per month for a single household and 1370euro for a couple; CBS, 2011).
- Health limitations, i.e. at least one health limitation on the EQ5D (Brooks, 1996)
Exclusion criteria
- High positive mental health: a high score on the Mental Health Continuum-Short Form (Lamers et al., 2010) - one standard deviation above the mean of the Dutch population, i.e. 4.83 or higher, to avoid ceiling effects.
- Serious depression: a score of 26 or higher on the Center for Epidemiology Depression Scale (CES-D) (Radloff, 1977; Bouma et al, 1995).
- Crisis situation: candidates who are in a (psychiatric) crisis or addicted to alcohol or drugs, or homeless, or having high debts, judged by the counselor during the intake
- Insufficient linguistic and cognitive skills to be able to fill in the questionnaires, judged by the counselor during intake
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 | NL39774.044.12 |
Other | NTR (TC = 3377) |