Mental IllnessPSYSNCT02316158
PsYoungSupport - Web-based Support to Young Careers to Persons With Mental Illness
A study testing Web-based support in people with Mental Illness and Web, run by Vardalinstitutet The Swedish Institute for Health Sciences at 1 site in Sweden.
Trial summary
The overall aim with the project PsYoungSupport is to evaluate Internet and communication technology (ICT) health efforts, i.e. information, education and support for young adults (16-25 years) who are first degree relatives or represent the close social network (relative or close friend) of individuals with mental… Read more about this study
- Who is it for?
- Ages 16 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Illness, Web
- What is being tested?
- Web-based support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2009to May 2010
- 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 16 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- age 16-25 years
- seeing themselves as a relative or close friend who supports a person with mental illness
Who cannot join
- persons who do not understand, read or express him-/herself in Swedish
- persons with acute severe mental illness or acute suicidal risk
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Vårdalinstitutet - The Swedish Institute for Health Sciences
Gothenburg, 405 30
About this study
Official title: PsYoungSupport Internet and Communication Technology Based Health Programmes - Information, Education and Support to Young People Close to Persons With Mental Illness
The overall aim with the project PsYoungSupport is to evaluate Internet and communication technology (ICT) health efforts, i.e. information, education and support for young adults (16-25 years) who are first degree relatives or represent the close social network (relative or close friend) of individuals with mental illness, with regard to the process (the quality and usefulness of the support) and the effect (on health and quality of life, situation as relative or part of close social network and consumption of other support/care) of the intervention.
The participatory design is one of the foundations of this project, and young adult participants will be consulted through out the research project. PsYoungSupport is a research program comprising three phases, Phase I is a survey of young relatives' and close friends' needs for internet based information, education and support, Phase II is the development of a website, and Phase III is an intervention based on the previous phases. The aim of phase III is to evaluate the effect of an internet based intervention containing information, education and support for young adults in families where a family member suffers from mental illness or functional disability. The participants (N=400) will be randomised to two groups with different kinds of support. The participants will be evaluated using self-questionnaires and web interviews at the following occasions: baseline at the start of the intervention, after 4 months and after 8 months. This project will have implications for persons suffering from mental illness as well as for their relatives and close friends.
Read the detailed description
In the last decades it has been stated that the mental health of young people has deteriorated. Nowadays, the main part of the psychiatric care are out-patient care, family, relatives and close friends get involved and needs to take large responsibility for their relative or friend with mental illness. Therefore it is important to acquire knowledge that could benefit the patients and their families. There is still a gap in the knowledge as to which social support, such as information and education processes, are of value to the patient and family struggling with depression, and as to how individuals benefits from these components in their functional recovery from depression. Accordingly, pedagogic processes as an integrated part of patient-centred care and treatment may be increasingly important to study.
The overall aim is to evaluate internet and communication technology (ICT) health efforts, i.e. information, education and support for young adults who are first degree relatives or represent the close social network (relative or close friend) of individuals with mental illness, with regard to the process (the quality and usefulness of the support) and the effect (on health and quality of life, situation as relative or part of close social network and consumption of other support/care) of the intervention.
PsYoungSupport is a research program comprising three phases, Phase I is a survey of young relatives' and close friends' needs for internet based information, education and support, Phase II is the development of a website, and Phase III is an intervention based on the previous phases. The investigators have a participatory design, including young persons in the whole research process. Primary outcome measures are social interaction, the degree of subjective and objective burden, stigmatisation and illness. Data are going to be based on both qualitative and quantitative approaches. The results are also going to evaluate cost effectiveness and the process of learning.
Within three years this project will describe different kind of implications for relatives and close friends who are caring for persons suffering from mental illness. Increased accessibility to knowledge about how mental health can benefit them and their relatives and close friends will facilitate for and empower these persons, and also increase their participation in society and with that increase the democracy for these persons in the society. Within five years this study can be integrated within the Swedish national website Care on line.
- Conditions
- Mental Illness, Web
- Being tested
- Web-based support
- Keywords
- Burden, Mental illness, Stress, Social support
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based supportOther
Also called website: www.molnhopp.nu
Comparison between the efficacy between webb-based support and informational support
| Study group | Role | What they receive |
|---|---|---|
| Webb-based support and education | Experimental | It contains of two parts 1) evidence based information (about mental diseases, early signs, coping strategies, what you can do for your relative or close friend, what you can do for yourself, addresses to networks and web sites, relevant juridical issues, etc), 2) FAQ, where you directly can find answers to common questions. Receives: Other: Web-based support |
| Available support in society | Active comparator | Available support in society for young persons presented in a brochure Receives: Other: Web-based support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased change in Burden
Cope Index (McKee, Philp, Lamura et al 2003. The Cope Index measures components such as negative effect of caring, positive values and the quality of support aspects of supporting a relative or close friend. Each question is answered on a 4-point scale with the alternative 'never' ,'sometimes', 'often' and 'always'. Some questions have the alternative of 'not applicable'. All scores are added within each area and high scores indicate a high level of negative effect, positive value and quality of support.
Measured: 8 months
Secondary outcomes (1)
Decreased Stress
Perceived Stress Scale (Cohen Kamch, Meremelstein, 1983). Measures the degree to which situations in individuals' daily life are appraised as stressful. The questions cover how the informant felt and thought during the last month. The questionaire consist of 10 items and each item is answered on a 5-point scale 0=never; 1=almost never; 2=sometimes; 3=faily often and 5=very often. PSS scores are obtained by reversing responses (e.g., 0=4; 1=3; 2=2; 3=1 and 4=0 to the 4 positively stated items (items 4,5,7 \& 8) and then summing across all scale items
Measured: Eight months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2014 (estimated)
- Study startMar 2009
- Primary completionJun 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental IllnessStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vardalinstitutet The Swedish Institute for Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ingela Skärsäter, PhD, Principal investigator, University of Gothenburg, 405 30 Göteborg, SwedenBarbro Krevers, PhD, Principal investigator, Linköping University, 581 83 Linköping, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316158
- Sponsor's protocol ID
- A2007003
- Acronym
- PSYS
- Status last verified
- Sep 2011
- First submitted
- 2 Sep 2011
- Last updated
- 12 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PsYoungSupport Internet and Communication Technology Based Health Programmes - Information, Education and Support to Young People Close to Persons With Mental Illness
- ClinicalTrials.gov ID
- NCT02316158
- Acronym / sponsor ID
- PSYS / A2007003
- Conditions
- Mental Illness, Web
- Keywords
- Burden, Mental illness, Stress, Social support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Vardalinstitutet The Swedish Institute for Health SciencesUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 12 Dec 2014 (estimated)
- 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 overall aim with the project PsYoungSupport is to evaluate Internet and communication technology (ICT) health efforts, i.e. information, education and support for young adults (16-25 years) who are first degree relatives or represent the close social network (relative or close friend) of individuals with mental illness, with regard to the process (the quality and usefulness of the support) and the effect (on health and quality of life, situation as relative or part of close social network and consumption of other support/care) of the intervention.
The participatory design is one of the foundations of this project, and young adult participants will be consulted through out the research project. PsYoungSupport is a research program comprising three phases, Phase I is a survey of young relatives' and close friends' needs for internet based information, education and support, Phase II is the development of a website, and Phase III is an intervention based on the previous phases. The aim of phase III is to evaluate the effect of an internet based intervention containing information, education and support for young adults in families where a family member suffers from mental illness or functional disability. The participants (N=400) will be randomised to two groups with different kinds of support. The participants will be evaluated using self-questionnaires and web interviews at the following occasions: baseline at the start of the intervention, after 4 months and after 8 months. This project will have implications for persons suffering from mental illness as well as for their relatives and close friends.
Detailed description
In the last decades it has been stated that the mental health of young people has deteriorated. Nowadays, the main part of the psychiatric care are out-patient care, family, relatives and close friends get involved and needs to take large responsibility for their relative or friend with mental illness. Therefore it is important to acquire knowledge that could benefit the patients and their families. There is still a gap in the knowledge as to which social support, such as information and education processes, are of value to the patient and family struggling with depression, and as to how individuals benefits from these components in their functional recovery from depression. Accordingly, pedagogic processes as an integrated part of patient-centred care and treatment may be increasingly important to study.
The overall aim is to evaluate internet and communication technology (ICT) health efforts, i.e. information, education and support for young adults who are first degree relatives or represent the close social network (relative or close friend) of individuals with mental illness, with regard to the process (the quality and usefulness of the support) and the effect (on health and quality of life, situation as relative or part of close social network and consumption of other support/care) of the intervention.
PsYoungSupport is a research program comprising three phases, Phase I is a survey of young relatives' and close friends' needs for internet based information, education and support, Phase II is the development of a website, and Phase III is an intervention based on the previous phases. The investigators have a participatory design, including young persons in the whole research process. Primary outcome measures are social interaction, the degree of subjective and objective burden, stigmatisation and illness. Data are going to be based on both qualitative and quantitative approaches. The results are also going to evaluate cost effectiveness and the process of learning.
Within three years this project will describe different kind of implications for relatives and close friends who are caring for persons suffering from mental illness. Increased accessibility to knowledge about how mental health can benefit them and their relatives and close friends will facilitate for and empower these persons, and also increase their participation in society and with that increase the democracy for these persons in the society. Within five years this study can be integrated within the Swedish national website Care on line.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Webb-based support and education | Experimental | Other: Web-based supportIt contains of two parts 1) evidence based information (about mental diseases, early signs, coping strategies, what you can do for your relative or close friend, what you can do for yourself, addresses to networks and web sites, relevant juridical issues, etc), 2) FAQ, where you directly can find answers to common questions. |
| Available support in society | Active comparator | Other: Web-based supportAvailable support in society for young persons presented in a brochure |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- age 16-25 years
- seeing themselves as a relative or close friend who supports a person with mental illness
Key exclusion criteria (2 listed)
- persons who do not understand, read or express him-/herself in Swedish
- persons with acute severe mental illness or acute suicidal risk
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 |
|---|---|---|
| Web-based supportAlso: website: www.molnhopp.nuComparison between the efficacy between webb-based support and informational support | Other | Available support in society, Webb-based support and education |
Primary outcome
Decreased change in Burden
Time frame: 8 months
Cope Index (McKee, Philp, Lamura et al 2003. The Cope Index measures components such as negative effect of caring, positive values and the quality of support aspects of supporting a relative or close friend. Each question is answered on a 4-point scale with the alternative 'never' ,'sometimes', 'often' and 'always'. Some questions have the alternative of 'not applicable'. All scores are added within each area and high scores indicate a high level of negative effect, positive value and quality of support.
1 secondary outcome
Decreased Stress
Time frame: Eight months
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 12 Dec 2014.
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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.
Ingela Skärsäter, PhD principal investigator
University of Gothenburg, 405 30 Göteborg, Sweden
Barbro Krevers, PhD principal investigator
Linköping University, 581 83 Linköping, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based support in people with Mental Illness and Web, run by Vardalinstitutet The Swedish Institute for Health Sciences at 1 site in Sweden.
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 2 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 12 Dec 2014. 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 Sweden. 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?
Decreased change in Burden (time frame: 8 months). 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 12 Dec 2014.