Substance Use DisordersNCT07303608
Improving Outcomes in Social Services Through Routine Outcome Monitoring and Systematic Client Feedback
A study testing Feedback informed treatment (FIT) and Treatment as usual (TAU) in people with Substance Use Disorders and Criminal Behavior, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
In this project the investigators want to test whether a new method FIT (Feedback informed treatment) can improve the interventions people receive through social services. The FIT method involves regularly providing information about how the client think things are going and what the client thinks about the help and… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Substance Use Disorders, Criminal Behavior, Domestic Violence
- What is being tested?
- Feedback informed treatment (FIT) and Treatment as usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSweden
- Study dates
- 5 Dec 2025to 15 Dec 2028
- Phase
- Interventional
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- People who have been granted assistance under the Social Services Act at includes centers.
Who cannot join
- People who do not have sufficient knowledge of Swedish or have impaired cognitive functions that prevent them from using FIT in Swedish, as they cannot benefit from the intervention that the study intends to evaluate the effects of. This is assessed by the respective social service.
- People who receive support and treatment interventions that are not voluntary, i.e. interventions according to the Act on the Compulsory Care of Young People (LVU) or the Act on the Compulsory Care of Drug Abusers (LVM)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Therese Nestor contact
About this study
Official title: Empowering Clients, Preventing Dropout and Improving Outcomes Through Routine Outcome Monitoring and Systematic Client Feedback in Social Services
In this project the investigators want to test whether a new method FIT (Feedback informed treatment) can improve the interventions people receive through social services. The FIT method involves regularly providing information about how the client think things are going and what the client thinks about the help and care they receive.
Read the detailed description
A randomized controlled trial conducted in social services' outpatient care, addiction care and in residential treatment. In addition to direct effects of using FIT (Feedback informed treatment), cost-effectiveness, instrument psychometrics and predictive value will be examined. The project include outcome measures for quality of life, behavior and symptoms which have been selected in collaboration with representatives of the users (social workers and clients). The project will also examine both clients' and social workers' experiences of giving and receiving feedback using FIT, as well as examine factors that influence implementation within social services.
Social services have an ambition to use evidence based practice, but there is a lack of methods that can help social workers and the social service to systematically follow and adapt the interventions based on the clients' situation, context and preferences. FIT is an internationally proven system for doing this. If findings of the current project are positive, it can be spread within social services through an existing network of practitioners and with existing digital tools.
Participating units with experience and interest in FIT will be recruited in collaboration with the Swedish FIT network and with already engaged municipalities and treatment units. The project will ensure that participating social workers have sufficient skills and that their workplace is ready to work with FIT. Clients who are granted treatment at the unit will be asked if they want to be included in a study where they can give feedback on the interventions they receive and help to follow their progress. After baseline, they will be randomized to treatment as usual or treatment with the addition of FIT. To support implementation, the therapists in the FIT group will be offered regular supervision.
- Conditions
- Substance Use Disorders, Criminal Behavior, Domestic Violence, Social Care, Family Communication, Family Conflict
- Being tested
- Feedback informed treatment (FIT), Treatment as usual (TAU)
- Keywords
- Social services, Feedback informed treatment, Systematic client feedback, Routine outcome management
- Medical subject headings
- Substance-Related Disorders, Criminal Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feedback informed treatment (FIT)Behavioural
Also called Partners for Change Outcome System (PCOMS), Outcome Rating Scale (ORS), System Rating Scale (SRS)
Consists of digital or paper tools that systematically collect feedback from the client and presents this to counselor or therapist. However, FIT is more than a collection of measures: an approach, both on the part of the social worker and on the part of the organization, where feedback from the client is actively sought and welcomed, and support of flexibility that interventions can be changed during the treatment period to prevent a negative outcome.
Treatment as usual (TAU)Behavioural
Also called Social services psychosocial support and treatment
Psychosocial support and treatment interventions to help clients in social services with various problems. This can be in the form of individual counselling, social casework, family and network interventions, and similar. These interventions include a variation of cognitive, behavioral, family therapeutic and psychodynamic therapeutic techniques as well as methods for supporting and caring for the client rather than treating specific conditions. The task of social services in Sweden borders to that of psychiatry, addiction care and the correctional system, which are organized on a regional or national level, as opposed to the municipal grounding of social services. Interventions are carried out in the client's environment, in outpatient care and through residential treatment facilities.
| Study group | Role | What they receive |
|---|---|---|
| Feedback-informed treatment (FIT) | Experimental | Feedback-informed treatment (FIT) added to treatment as usual. The social workers will use FIT together with the participant at each visit or unit of service (week) The components of FIT is administrating the Outcome Rating Scale at the beginning of session and Session Rating Scale at the end of the session, calculating and interpreting the values (digitally or manually) as well as discussing the results, trying to create a culture of feedback (actively seek and value honest client input). Receives: Behavioral: Feedback informed treatment (FIT); Behavioral: Treatment as usual (TAU) |
| Treatment as usual (TAU) | Active comparator | Treatment as usual at social services without the use of the components in Feedback informed treatment. Receives: Behavioral: Treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main problem level
The participant choose their main problem area that is addressed in their contact with social servises (Work, employment, finances; School, studies; Alcohol, drugs or gambling; Mental health; Violent behavior or crime; Violence in close relationships; Housing and/or everyday routines; Relationship problems; Other) and rate the problems they have experienced in this area on a visual analog scale (0-100) where a higher number indicate more severe problems.
Measured: Baseline, three months, six months and one year
Secondary outcomes (5)
Days of problem in main area
The participant rate the number of days the last months 0-30 that they have experienced problems in their main problem area.
Measured: Baseline, three months, six months and one year
Secondary problem level
The participant can choose one or two secondary problem areas that is addressed in their contact with social services and rate the problem (0-100) they have experienced in this area. A higher number indicate more severe problems.
Measured: Baseline, three months, six months and one year
Days of problem in secondary area
The participant rate the number of days in the last month (0-30) that they have experienced problems in their secondary problem area.
Measured: Baseline, three months, six months and one year
Clinical outcomes in routine evaluation outcome measure (CORE-OM-8)
Patient reported outcome measures. An 8-item alternative brief measure of psychological distress, based on the shorter CORE-OM-6D for this population. Each item is scored 0-4 (0-26 in total). A higher score indicate more severe problems.
Measured: Baseline, three months, six months and one year
EuroQol Five Dimensions (EQ-5D)
Health questionnaire measuring quality of life in five areas: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each area is rated 1-5 to form an index. A higher score indicate more severe problems.
Measured: Baseline, three months, six months and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start5 Dec 2025
- Primary completion15 Jun 2028 (estimated)
- Study completion15 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magnus Johansson, Karolinska Institutet
- Investigators
- Magnus Johansson, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303608
- Sponsor's protocol ID
- 2025-00833-01
- Other IDs
- 2023-01738, 2023, 2025
- Status last verified
- Dec 2025
- First submitted
- 26 Nov 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD might not be shared because participants are at risk of being identified. Some of the participating social service units are small and may only recruit a small number of participants that could be identified through a combination of demographic variables.