Well-beingYouthCOMPASSNCT03274934
The Effectiveness of the Mobile-based Youth COMPASS Program to Promote Adolescent Well-being and Life-control
A study testing Experimental: face-to-face and online support group: and Experimental: only online support group: in people with Well-being, run by University of Jyvaskyla at 1 site in Finland.
Trial summary
The aim of this randomized control trial is to examine effectiveness of individually tailored web- and mobile-based Acceptance- and Commitment Therapy interventions to promote adolescents' well-being and life-control and subsequently support their successful transition from basic education to upper secondary… Read more about this study
- Who is it for?
- Ages 14 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Well-being
- What is being tested?
- Experimental: face-to-face and online support group: and Experimental: only online support group:
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 1 siteFinland
- Study dates
- 21 Sep 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Adolescents (n = 120) who have risk for school failure (learning difficulties or low grade point average without learning difficulties)
- Randomly chosen adolescents (n=120) from the same classrooms who have no risk for school failure
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Finland1 site
Department of Psychology, University of Jyväskylä
Jyväskylä, 40014
About this study
Official title: The Effectiveness of the Novel Web- and Mobile-based Acceptance- and Commitment Therapy Program Youth COMPASS to Promote Adolescent Well-being and Life-control
The aim of this randomized control trial is to examine effectiveness of individually tailored web- and mobile-based Acceptance- and Commitment Therapy interventions to promote adolescents' well-being and life-control and subsequently support their successful transition from basic education to upper secondary education. Our additional aim is to examine to what extent the effectiveness of the intervention varies according to intervention intensity and according to risk for school failure. The five-week structured intervention is delivered using the novel web-and mobile-based program Youth COMPASS following the principles of the Acceptance and Commitment Therapy (ACT). The Internet context is assumed to be particularly motivating for youth who enjoy spending time online using different social media. Internet-based interventions have several advantages; they can include more information and treatment components than traditionally delivered treatments and that intervention programs are accessible at any time and at any place. Another unique aspect of the Youth COMPASS is the fact that it is individually-tailored. Each participant have an individually assigned online coach who provides support and encouragement, reminds about Youth COMPASS, sends individualized feedback, and recommends different exercises. The study hypothetizes that the Youth COMPASS is more effective than school counseling as usual. More specifically, the Youth COMPASS is expected to be more effective when it is combined with face-to-face support than when support and feedback are provided only via the Internet. Also, the Youth COMPASS with no face-to-face support (online only) is expected to be more effective than receiving only regular school counseling. Finally, the Youth COMPASS is expected to be more effective for students at risk for school failure than for students without risk for school failure, especially when at risk-adolescents receive more intensive support (i.e., both online and face-to-face support).
Read the detailed description
The aim of this randomized control trial is to examine effectiveness of individually tailored web- and mobile-based Acceptance- and Commitment Therapy interventions to promote adolescents' well-being and life-control and subsequently support their successful transition from basic education to upper secondary education. Our additional aim is to examine to what extent the effectiveness of the intervention varies according to intervention intensity and according to risk for school failure. The five-week structured intervention is delivered using the novel web-and mobile-based program Youth COMPASS following the principles of the Acceptance and Commitment Therapy (ACT). The Internet context is assumed to be particularly motivating for youth who enjoy spending time online using different social media. Internet-based interventions have several advantages; they can include more information and treatment components than traditionally delivered treatments and that intervention programs are accessible at any time and at any place. Another unique aspect of the Youth COMPASS is the fact that it is individually-tailored. Each participant have an individually assigned online coach who provides support and encouragement, reminds about Youth COMPASS, sends individualized feedback, and recommends different exercises. The study hypothetizes that the Youth COMPASS is more effective than school counseling as usual. More specifically, the Youth COMPASS is expected to be more effective when it is combined with face-to-face support than when support and feedback are provided only via the Internet. Also, the Youth COMPASS with no face-to-face support (online only) is expected to be more effective than receiving only regular school counseling. Finally, the Youth COMPASS is expected to be more effective for students at risk for school failure than for students without risk for school failure, especially when at risk-adolescents receive more intensive support (i.e., both online and face-to-face support). The participants of the effectiveness study of the Youth COMPASS are selected from the participants of the broader longitudinal STAIRWAY (TIKAPUU in Finnish) - From Primary School to Secondary School study, which follows a community sample of Finnish adolescents (n~850) across critical educational transitions. The overall aim of the STAIRWAY project is to broaden our understanding of the individual- and environment-related factors that promote learning, well-being and successful educational transitions.
- Conditions
- Well-being
- Being tested
- Experimental: face-to-face and online support group:, Experimental: only online support group:, Control
- Keywords
- Adolescents, Web- and mobile-based intervention, Acceptance and Commitment therapy, Psychological well-being, Career preparation, Lifecontrol, Successful educational transitions, Learning difficulties, Psychological flexibility and mindfulness skills
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: face-to-face and online support group:Behavioural
5-week intervention according to Acceptance and Commitment Therapy principles with the web-and mobile-based Youth COMPASS program, face-to-face support (2 meetings) and weekly online mobile support and feedback from the individually assigned coach (one third of the participants is randomly assigned to this group)
Experimental: only online support group:Behavioural
5-week intervention according to ACT principles with the web-and mobile-based Youth COMPASS program, no face-to-face support, weekly mobile online support and feedback from the individually assigned coach (one third of the participants is randomly assigned to this group)
ControlBehavioural
Control group, no intervention, school counseling as usual. (one third of the participants is randomly assigned to this group)
| Study group | Role | What they receive |
|---|---|---|
| Face-to-face and online support group | Experimental | Behavioral: Structured web- and mobile-based intervention with Youth COMPASS program to support adolescents' well-being, career preparation and life-control and subsequently support successful transition to upper secondary education. The Youth COMPASS is the five-week online program according to principles of Acceptance and Commitment Therapy aiming to enhance adolescents' psychological flexibility by guiding adolescents in exploring their values and setting goals and changing behaviors according to their goals (week 1), and learning acceptance defusion and mindfulness skills (weeks 2-3) and integrating these skills into their personal life (weeks 4-5). The participants in this condition receive weekly online support and feedback from their individually assigned coach. In addition, they meet their coach twice in the face-to-face meetings. The aim of the meetings is to increase adolescents' internal motivation and thereby participation in the program. Receives: Behavioral: Experimental: face-to-face and online support group: |
| Only online support group | Experimental | Behavioral: web- and mobile-based intervention with Youth COMPASS program to support adolescents' well-being, career preparation and life-control and subsequently support successful transition to upper secondary education. The Youth COMPASS is a five-week online program according to principles of Acceptance and Commitment Therapy aiming to enhance adolescents' psychological flexibility by guiding adolescents in exploring their values and setting goals and changing behaviors according to their goals (week 1), and learning acceptance defusion and mindfulness skills (weeks 2-3) and integrating these skills into their personal life (weeks 4-5). The participants in this condition receive weekly online support and feedback from their individually assigned coach. Receives: Behavioral: Experimental: only online support group: |
| Control group | Experimental | Behavioral: No intervention, school counseling as usual Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Life satisfaction (Diener et al., 1985)
Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
Measured: Change from baseline at 2, 6, 12 and 18 months after the intervention.
Self-esteem (Rosenberg, 1965),
Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
Measured: Change from baseline at 2, 6, 12 and 18 months after the intervention.
Depressive symptoms (Salokangas et al., 1995)
Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
Measured: Change from baseline at 2, 6, 12 and 18 months after the intervention.
Stress (Elo et al., 2003)
Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
Measured: Change from baseline at 2, 6, 12 and 18 months after the intervention.
Difficulties and Strenghts questionnaire (SDQ, Goodman et al. 1997) measuring emotional symptoms, hyperactivity, conduct problems and prosociality
Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
Measured: Change from baseline at 2, 6, 12 and 18 months after the intervention.
Well-being in school (World Health Organization)
Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
Measured: Change from baseline at 2, 6, 12 and 18 months after the intervention.
Career choice preparedness (Koivisto et al., 2011)
Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
Measured: Change from baseline at 2, 6, 12 and 18 months after the intervention.
Educational expectations
Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
Measured: Change from baseline at 2, 6, 12 and 18 months after the intervention.
Secondary outcomes (10)
Psychological flexibility (Greco et al., 2008)
Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
Measured: Change from baseline at 2, 6, 12 and 18 months after the intervention.
Mindfulness skills (Ciarrochi et al., 2011)
Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
Measured: Change from baseline at 2, 6, 12 and 18 months after the intervention.
Identity formation (DIDS; Luyckx et al., 2008; see also Marttinen et al., 2016)
In addition to self-reports, also school register information is collected regarding academic performance, school absences and progress in studies.
Measured: Change from baseline at 2, 6, 12 and 18 months after the intervention
Truancy
Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
Measured: Change from baseline at 2, 6, 12 and 18 months after the intervention.
School grades
In addition to self-reports, also school register information is collected.
Measured: Four years from the baseline.
Initiation of upper secondary education
In addition to self-reports, also school register information is collected.
Measured: Four years from the baseline.
Progress in upper secondary studies
In addition to self-reports, also school register information is collected.
Measured: Four years from the baseline.
Changes in study field in upper secondary education
In addition to self-reports, also school register information is collected.
Measured: Four years from the baseline.
Staying in vs. dropping out of education
In addition to self-reports, also school register information is collected.
Measured: Four years from the baseline.
Graduation time
In addition to self-reports, also school register information is collected.
Measured: Four years from the baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start21 Sep 2017
- Primary completion15 Dec 2017
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Well-beingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Treatment, Parallel assessment, Randomized, Efficacy study
- Masking
- None (open label)
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jyvaskyla
- Sponsor type
- University, hospital or other
- Collaborators
- the Finnish Cultural Foundation, Central Finland Regional Fund
- Responsible party
- Sponsor
- Investigators
- Noona Kiuru, PhD, Principal investigator, Department of Psychology, University of Jyväskylä, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03274934
- Sponsor's protocol ID
- 21000039071
- Acronym
- YouthCOMPASS
- Status last verified
- Apr 2020
- First submitted
- 1 Sep 2017
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Other researchers are encouraged to use the data; however, it requires a research plan and the permission of the research team. Also, at least one of the team members, who know the data well, should be a co-author in all the articles that are written from the data. After 10 years of the data collection, those parts of the data that are not too sensitive (e.g., part of the questionnaire data), will be prepared in collaboration with a Finnish Social Science data Archive in a format that is easily accessible for other researchers. However, using data requires a research plan and the permission of the research team. Also, at least one of the team members, who know the data well, should be a co-author in all the articles that are written from the data.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the Novel Web- and Mobile-based Acceptance- and Commitment Therapy Program Youth COMPASS to Promote Adolescent Well-being and Life-control
- ClinicalTrials.gov ID
- NCT03274934
- Acronym / sponsor ID
- YouthCOMPASS / 21000039071
- Conditions
- Well-being
- Keywords
- Adolescents, Web- and mobile-based intervention, Acceptance and Commitment therapy, Psychological well-being, Career preparation, Lifecontrol, Successful educational transitions, Learning difficulties
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- University of JyvaskylaUniversity, hospital or other
- Collaborators
- the Finnish Cultural Foundation, Central Finland Regional Fund
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 7 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this randomized control trial is to examine effectiveness of individually tailored web- and mobile-based Acceptance- and Commitment Therapy interventions to promote adolescents' well-being and life-control and subsequently support their successful transition from basic education to upper secondary education. Our additional aim is to examine to what extent the effectiveness of the intervention varies according to intervention intensity and according to risk for school failure. The five-week structured intervention is delivered using the novel web-and mobile-based program Youth COMPASS following the principles of the Acceptance and Commitment Therapy (ACT). The Internet context is assumed to be particularly motivating for youth who enjoy spending time online using different social media. Internet-based interventions have several advantages; they can include more information and treatment components than traditionally delivered treatments and that intervention programs are accessible at any time and at any place. Another unique aspect of the Youth COMPASS is the fact that it is individually-tailored. Each participant have an individually assigned online coach who provides support and encouragement, reminds about Youth COMPASS, sends individualized feedback, and recommends different exercises. The study hypothetizes that the Youth COMPASS is more effective than school counseling as usual. More specifically, the Youth COMPASS is expected to be more effective when it is combined with face-to-face support than when support and feedback are provided only via the Internet. Also, the Youth COMPASS with no face-to-face support (online only) is expected to be more effective than receiving only regular school counseling. Finally, the Youth COMPASS is expected to be more effective for students at risk for school failure than for students without risk for school failure, especially when at risk-adolescents receive more intensive support (i.e., both online and face-to-face support).
Detailed description
The aim of this randomized control trial is to examine effectiveness of individually tailored web- and mobile-based Acceptance- and Commitment Therapy interventions to promote adolescents' well-being and life-control and subsequently support their successful transition from basic education to upper secondary education. Our additional aim is to examine to what extent the effectiveness of the intervention varies according to intervention intensity and according to risk for school failure. The five-week structured intervention is delivered using the novel web-and mobile-based program Youth COMPASS following the principles of the Acceptance and Commitment Therapy (ACT). The Internet context is assumed to be particularly motivating for youth who enjoy spending time online using different social media. Internet-based interventions have several advantages; they can include more information and treatment components than traditionally delivered treatments and that intervention programs are accessible at any time and at any place. Another unique aspect of the Youth COMPASS is the fact that it is individually-tailored. Each participant have an individually assigned online coach who provides support and encouragement, reminds about Youth COMPASS, sends individualized feedback, and recommends different exercises. The study hypothetizes that the Youth COMPASS is more effective than school counseling as usual. More specifically, the Youth COMPASS is expected to be more effective when it is combined with face-to-face support than when support and feedback are provided only via the Internet. Also, the Youth COMPASS with no face-to-face support (online only) is expected to be more effective than receiving only regular school counseling. Finally, the Youth COMPASS is expected to be more effective for students at risk for school failure than for students without risk for school failure, especially when at risk-adolescents receive more intensive support (i.e., both online and face-to-face support). The participants of the effectiveness study of the Youth COMPASS are selected from the participants of the broader longitudinal STAIRWAY (TIKAPUU in Finnish) - From Primary School to Secondary School study, which follows a community sample of Finnish adolescents (n~850) across critical educational transitions. The overall aim of the STAIRWAY project is to broaden our understanding of the individual- and environment-related factors that promote learning, well-being and successful educational transitions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Treatment, Parallel assessment, Randomized, Efficacy study
| Arm | Type | Receives |
|---|---|---|
| Face-to-face and online support group | Experimental | Behavioral: Experimental: face-to-face and online support group:Behavioral: Structured web- and mobile-based intervention with Youth COMPASS program to support adolescents' well-being, career preparation and life-control and subsequently support successful transition to upper secondary education. The Youth COMPASS is the five-week online program according to principles of Acceptance and Commitment Therapy aiming to enhance adolescents' psychological flexibility by guiding adolescents in exploring their values and setting goals and changing behaviors according to their goals (week 1), and learning acceptance defusion and mindfulness skills (weeks 2-3) and integrating these skills into their personal life (weeks 4-5). The participants in this condition receive weekly online support and feedback from their individually assigned coach. In addition, they meet their coach twice in the face-to-face meetings. The aim of the meetings is to increase adolescents' internal motivation and thereby participation in the program. |
| Only online support group | Experimental | Behavioral: Experimental: only online support group:Behavioral: web- and mobile-based intervention with Youth COMPASS program to support adolescents' well-being, career preparation and life-control and subsequently support successful transition to upper secondary education. The Youth COMPASS is a five-week online program according to principles of Acceptance and Commitment Therapy aiming to enhance adolescents' psychological flexibility by guiding adolescents in exploring their values and setting goals and changing behaviors according to their goals (week 1), and learning acceptance defusion and mindfulness skills (weeks 2-3) and integrating these skills into their personal life (weeks 4-5). The participants in this condition receive weekly online support and feedback from their individually assigned coach. |
| Control group | Experimental | Behavioral: ControlBehavioral: No intervention, school counseling as usual |
Who may qualify
- Ages
- 14 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Adolescents (n = 120) who have risk for school failure (learning difficulties or low grade point average without learning difficulties)
- Randomly chosen adolescents (n=120) from the same classrooms who have no risk for school failure
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: face-to-face and online support group:5-week intervention according to Acceptance and Commitment Therapy principles with the web-and mobile-based Youth COMPASS program, face-to-face support (2 meetings) and weekly online mobile support and feedback from the individually assigned coach (one third of the participants is randomly assigned to this group) | Behavioural | Face-to-face and online support group |
| Experimental: only online support group:5-week intervention according to ACT principles with the web-and mobile-based Youth COMPASS program, no face-to-face support, weekly mobile online support and feedback from the individually assigned coach (one third of the participants is randomly assigned to this group) | Behavioural | Only online support group |
| ControlControl group, no intervention, school counseling as usual. (one third of the participants is randomly assigned to this group) | Behavioural | Control group |
Primary outcome
Life satisfaction (Diener et al., 1985)
Time frame: Change from baseline at 2, 6, 12 and 18 months after the intervention.
Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
Self-esteem (Rosenberg, 1965),
Time frame: Change from baseline at 2, 6, 12 and 18 months after the intervention.
Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
Depressive symptoms (Salokangas et al., 1995)
Time frame: Change from baseline at 2, 6, 12 and 18 months after the intervention.
Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
Stress (Elo et al., 2003)
Time frame: Change from baseline at 2, 6, 12 and 18 months after the intervention.
Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
Difficulties and Strenghts questionnaire (SDQ, Goodman et al. 1997) measuring emotional symptoms, hyperactivity, conduct problems and prosociality
Time frame: Change from baseline at 2, 6, 12 and 18 months after the intervention.
Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
Well-being in school (World Health Organization)
Time frame: Change from baseline at 2, 6, 12 and 18 months after the intervention.
Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
Career choice preparedness (Koivisto et al., 2011)
Time frame: Change from baseline at 2, 6, 12 and 18 months after the intervention.
Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
Educational expectations
Time frame: Change from baseline at 2, 6, 12 and 18 months after the intervention.
Study has five timepoints when same questionnaires are administered to assess possible changes in the outcome measures.
10 secondary outcomes
Psychological flexibility (Greco et al., 2008)
Time frame: Change from baseline at 2, 6, 12 and 18 months after the intervention.
Mindfulness skills (Ciarrochi et al., 2011)
Time frame: Change from baseline at 2, 6, 12 and 18 months after the intervention.
Identity formation (DIDS; Luyckx et al., 2008; see also Marttinen et al., 2016)
Time frame: Change from baseline at 2, 6, 12 and 18 months after the intervention
Truancy
Time frame: Change from baseline at 2, 6, 12 and 18 months after the intervention.
School grades
Time frame: Four years from the baseline.
Initiation of upper secondary education
Time frame: Four years from the baseline.
Progress in upper secondary studies
Time frame: Four years from the baseline.
Changes in study field in upper secondary education
Time frame: Four years from the baseline.
Staying in vs. dropping out of education
Time frame: Four years from the baseline.
Graduation time
Time frame: Four years from the baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
- Individual participant dataSharing planned: Yes. Other researchers are encouraged to use the data; however, it requires a research plan and the permission of the research team. Also, at least one of the team members, who know the data well, should be a co-author in all the articles that are written from the data. After 10 years of the data collection, those parts of the data that are not too sensitive (e.g., part of the questionnaire data), will be prepared in collaboration with a Finnish Social Science data Archive in a format that is easily accessible for other researchers. However, using data requires a research plan and the permission of the research team. Also, at least one of the team members, who know the data well, should be a co-author in all the articles that are written from the data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noona Kiuru, PhD principal investigator
Department of Psychology, University of Jyväskylä, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: face-to-face and online support group: and Experimental: only online support group: in people with Well-being, run by University of Jyvaskyla at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Life satisfaction (Diener et al., 1985) (time frame: Change from baseline at 2, 6, 12 and 18 months after the intervention.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2020.