Psychosocial ProblemsALIMEnt IINCT07908095
The Impact of Continuous Case Support and Resource Provision in Clinical Social Work Interventions
An observational study of Psychosocial Problems and Social Support Needs, run by Andrea Zumbrunn at 1 site in Switzerland.
Trial summary
Health-related social work fulfills an important function in accompanying and supporting individuals who are affected by health-related, social, and material problems. Despite many years of practical experience, however, there is still a lack of scientific evidence regarding its effectiveness, both in Switzerland and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychosocial Problems, Social Support Needs, Chronic Illness
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2026to Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clients from various clinical social work organizations in German-speaking Switzerland who present with both health-related and psychosocial problems and start to be engaged in longer-term support provided by social work professionals.
Who may be able to join
- The person has both, health-related and psychosocial problems.
- Multiple consultations and different forms of social work support are likely to be required.
- The person is able to understand and respond to questions formulated in German.
- The person is sufficiently stable to provide information about their own situation without negatively affecting their well-being
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University of Applied Sciences and Arts Northwestern Switzerland (FHNW)
Olten
Solèr Maria, +41 62 957 26 23, maria.solèr@fhnw.ch
About this study
Official title: Wirksamkeit Von Begleiten Und Ausstatten in Interventionskontexten Der Klinischen Sozialen Arbeit (ALIMEnt II)
Health-related social work fulfills an important function in accompanying and supporting individuals who are affected by health-related, social, and material problems. Despite many years of practical experience, however, there is still a lack of scientific evidence regarding its effectiveness, both in Switzerland and internationally. Reliable instruments for measuring the services provided by social work are lacking, as are representative studies.
The ALIMEnt II study aims to further develop procedures for evidence-based impact measurement in the field of health-related social work and to contribute to closing this research gap:
Read more
- By developing an instrument (measurement scale) to reliably assess the activities of social workers.
- By applying this instrument to examine two central functions of health-related social work: providing support (accompaniment) and facilitating access to resources.
The instrument captures which services are provided from the perspectives of both social workers and clients, as well as how clients' situations change over time from both their perspectives. This questionnaire will be used in a subsequent longitudinal study to examine the relationship between specific methods of professional practice and client outcomes.
The results are intended to demonstrate the extent to which the instrument can be reliably used to capture the services of social work, and to provide evidence of the effectiveness of accompaniment and resource provision under different practice conditions.
Investigating the assumed causal relationships under complex real-world practice conditions is challenging. To address this, the investigators use an impact model of health-related social work that was developed in a previous empirical study (ALIMEnt I). Both clients and social workers from the field of health-related social work will participate in the ALIMEnt II study.
- Conditions
- Psychosocial Problems, Social Support Needs, Chronic Illness
- Medical subject headings
- Chronic Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of perceived stress and burden (PSS) from baseline to 3 and 6 months
Perceived Stress Scale PSS Subscale Perceived Helplessness: 6 items (items 1, 2, 3, 6, 9, 10); Each item scored 0-4 → range: 0-24; Higher scores = greater feelings of lack of control over circumstances or emotions Subscale Perceived Self-Efficacy: 4 items (items 4, 5, 7, 8); Each item scored 0-4 → range: 0-16; Higher scores = greater perceived inability to handle problems (i.e., lower self-efficacy)
Measured: At baseline (initiation of support), and at 3 and 6 months
Change of self-determined live conduct through the assessment of capabilities (OxCAP) from baseline to 3 and to 6 months
OxCAP-MH Oxford CAPabilities questionnaire for Mental Health: Raw score range: 16-80 (16 items, each scored 1-5), standardized to 0-100; Higher scores = higher level of capabilities/quality of life; in our study Item-level analysis
Measured: At baseline (initiation of support), and at 3 and 6 months
Change of navigation of and knowledge about the support system (self-developed items) from baseline to 3 and to 6 months
Self-constructed items, inspired by DSS - Discontinuation Success Scale, I am able to navigate the support system (disability insurance, accident insurance, physicians, etc.) well./ I know where to turn to get the right support when I need it.
Rated on a 5-point Likert scale (1 = does not apply to 5 = fully applies)
Measured: At baseline (initiation of support), and at 3 and 6 months
Change of self-determined live conduct through the assessment of social participation (F-SozU) from baseline to 3 and to 6 months
F-SozU - Social Integration scale (SI): 13 items (long form S-54); Rated on a 5-point Likert scale (1 = does not apply to 5 = fully applies); Range: 13-65 (or 1-5 when using the mean score); Content: belonging to a circle of friends, engaging in joint activities, knowing people with similar interests/values; Higher scores = greater social integration
Measured: At baseline (initiation of support), and at 3 and 6 months
Secondary outcomes (1)
Change of hope for improvement (FPTM) in one's condition from baseline to 3 and to 6 month
FPTM - Questionnaire for Psychotherapy Motivation - Hope scale (HO): Original version (FPTM-39): 7 items, 4-point response format (1-4) → Range: 7-28; Higher scores = greater confidence/optimism regarding improvement through treatment (interpreted positively, indicating higher therapy motivation); in our study item-level analysis
Measured: At baseline (initiation of support), and at 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start1 Jun 2026
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychosocial ProblemsStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrea Zumbrunn
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Sponsor-investigator, Andrea Zumbrunn, University of Applied Sciences and Arts Northwestern Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908095
- Sponsor's protocol ID
- EAaFE260413
- Other IDs
- 10002847
- Acronym
- ALIMEnt II
- Status last verified
- Oct 2026
- First submitted
- 19 Aug 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The anonymised IPD and data dictionaries for the IPD will be published on SWISSUbase, FORS's online platform, for non-commercial purposes. Under our licence (CC BY-ND 4.0), anyone using the data is required to cite the project and the applicants (including a reference to the fact that this is an SNSF project).
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wirksamkeit Von Begleiten Und Ausstatten in Interventionskontexten Der Klinischen Sozialen Arbeit (ALIMEnt II)
- ClinicalTrials.gov ID
- NCT07908095
- Acronym / sponsor ID
- ALIMEnt II / EAaFE260413
- Conditions
- Psychosocial Problems, Social Support Needs, Chronic Illness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Andrea ZumbrunnUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 30 Oct 2026 (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.
Health-related social work fulfills an important function in accompanying and supporting individuals who are affected by health-related, social, and material problems. Despite many years of practical experience, however, there is still a lack of scientific evidence regarding its effectiveness, both in Switzerland and internationally. Reliable instruments for measuring the services provided by social work are lacking, as are representative studies.
The ALIMEnt II study aims to further develop procedures for evidence-based impact measurement in the field of health-related social work and to contribute to closing this research gap:
- By developing an instrument (measurement scale) to reliably assess the activities of social workers.
- By applying this instrument to examine two central functions of health-related social work: providing support (accompaniment) and facilitating access to resources.
The instrument captures which services are provided from the perspectives of both social workers and clients, as well as how clients' situations change over time from both their perspectives. This questionnaire will be used in a subsequent longitudinal study to examine the relationship between specific methods of professional practice and client outcomes.
The results are intended to demonstrate the extent to which the instrument can be reliably used to capture the services of social work, and to provide evidence of the effectiveness of accompaniment and resource provision under different practice conditions.
Investigating the assumed causal relationships under complex real-world practice conditions is challenging. To address this, the investigators use an impact model of health-related social work that was developed in a previous empirical study (ALIMEnt I). Both clients and social workers from the field of health-related social work will participate in the ALIMEnt II study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clients from various clinical social work organizations in German-speaking Switzerland who present with both health-related and psychosocial problems and start to be engaged in longer-term support provided by social work professionals.
Key inclusion criteria (4 listed)
- The person has both, health-related and psychosocial problems.
- Multiple consultations and different forms of social work support are likely to be required.
- The person is able to understand and respond to questions formulated in German.
- The person is sufficiently stable to provide information about their own situation without negatively affecting their well-being
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.
Primary outcome
Change of perceived stress and burden (PSS) from baseline to 3 and 6 months
Time frame: At baseline (initiation of support), and at 3 and 6 months
Perceived Stress Scale PSS Subscale Perceived Helplessness: 6 items (items 1, 2, 3, 6, 9, 10); Each item scored 0-4 → range: 0-24; Higher scores = greater feelings of lack of control over circumstances or emotions Subscale Perceived Self-Efficacy: 4 items (items 4, 5, 7, 8); Each item scored 0-4 → range: 0-16; Higher scores = greater perceived inability to handle problems (i.e., lower self-efficacy)
Change of self-determined live conduct through the assessment of capabilities (OxCAP) from baseline to 3 and to 6 months
Time frame: At baseline (initiation of support), and at 3 and 6 months
OxCAP-MH Oxford CAPabilities questionnaire for Mental Health: Raw score range: 16-80 (16 items, each scored 1-5), standardized to 0-100; Higher scores = higher level of capabilities/quality of life; in our study Item-level analysis
Change of navigation of and knowledge about the support system (self-developed items) from baseline to 3 and to 6 months
Time frame: At baseline (initiation of support), and at 3 and 6 months
Self-constructed items, inspired by DSS - Discontinuation Success Scale, I am able to navigate the support system (disability insurance, accident insurance, physicians, etc.) well./ I know where to turn to get the right support when I need it. Rated on a 5-point Likert scale (1 = does not apply to 5 = fully applies)
Change of self-determined live conduct through the assessment of social participation (F-SozU) from baseline to 3 and to 6 months
Time frame: At baseline (initiation of support), and at 3 and 6 months
F-SozU - Social Integration scale (SI): 13 items (long form S-54); Rated on a 5-point Likert scale (1 = does not apply to 5 = fully applies); Range: 13-65 (or 1-5 when using the mean score); Content: belonging to a circle of friends, engaging in joint activities, knowing people with similar interests/values; Higher scores = greater social integration
1 secondary outcome
Change of hope for improvement (FPTM) in one's condition from baseline to 3 and to 6 month
Time frame: At baseline (initiation of support), and at 3 and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- General information about the project for participating organizations and patientsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The anonymised IPD and data dictionaries for the IPD will be published on SWISSUbase, FORS's online platform, for non-commercial purposes. Under our licence (CC BY-ND 4.0), anyone using the data is required to cite the project and the applicants (including a reference to the fact that this is an SNSF project).
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychosocial Problems and Social Support Needs, run by Andrea Zumbrunn at 1 site in Switzerland.
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 4 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: looking for participants now, as of the sponsor's last update on 30 Oct 2026. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Dr. Andrea Zumbrunn (+41 62 957 21 62, andrea.zumrbunn@fhnw.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of perceived stress and burden (PSS) from baseline to 3 and 6 months (time frame: At baseline (initiation of support), and at 3 and 6 months). The study lists 4 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 30 Oct 2026.