NCT07303608

Brief 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 care they receive.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started Dec 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
Dec 2025Dec 2028

First Submitted

Initial submission to the registry

November 26, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

December 5, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 26, 2025

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2028

Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

2.5 years

First QC Date

November 26, 2025

Last Update Submit

December 18, 2025

Conditions

Keywords

Social servicesFeedback informed treatmentSystematic client feedbackRoutine outcome management

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, three months, six months and one year

Secondary Outcomes (5)

  • Days of problem in main area

    Baseline, three months, six months and one year

  • Secondary problem level

    Baseline, three months, six months and one year

  • Days of problem in secondary area

    Baseline, three months, six months and one year

  • Clinical outcomes in routine evaluation outcome measure (CORE-OM-8)

    Baseline, three months, six months and one year

  • EuroQol Five Dimensions (EQ-5D)

    Baseline, three months, six months and one year

Other Outcomes (4)

  • Outcome rating scale (ORS)

    during experimental treatment, up to 55 weeks

  • Session Rating Scale (SRS)

    during experimental treatment, up to 55 weeks

  • Satisfaction with contact and therapeutic relationship

    three months, six months and one year

  • +1 more other outcomes

Study Arms (2)

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).

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.

Behavioral: Treatment as usual (TAU)

Interventions

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.

Also known as: Partners for Change Outcome System (PCOMS), Outcome Rating Scale (ORS), System Rating Scale (SRS)
Feedback-informed treatment (FIT)

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.

Also known as: Social services psychosocial support and treatment
Feedback-informed treatment (FIT)Treatment as usual (TAU)

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • People who have been granted assistance under the Social Services Act at includes centers.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linköpings kommun

Linköping, Sweden

RECRUITING

MeSH Terms

Conditions

Substance-Related DisordersCriminal Behavior

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersBehavior

Study Officials

  • Magnus Johansson, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Magnus Johansson, PhD

CONTACT

Therese Nestor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 26, 2025

First Posted

December 26, 2025

Study Start

December 5, 2025

Primary Completion (Estimated)

June 15, 2028

Study Completion (Estimated)

December 15, 2028

Last Updated

December 26, 2025

Record last verified: 2025-12

Locations