Psychiatric DiagnosisFIT-ACCESSNCT07280767
Does Implementation of Feedback Informed Therapy (FIT) Improve Access to Psychotherapy in Psychiatry?
An observational study of Psychiatric Diagnosis, run by Region Skane at 1 site in Sweden.
Trial summary
This study explores whether the introduction of Feedback-Informed Therapy (FIT) can improve access to psychotherapy within adult psychiatric outpatient care. FIT is a person-centered method where patients regularly provide structured feedback on their progress and therapeutic alliance, allowing treatment to be… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Psychiatric Diagnosis
- What is being tested?
- Feedbeack Informed Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 213 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2024to 30 Nov 2025
- Phase
- Observational
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adults receiving psychotherapy at two general psychiatric outpatient clinics in southern Sweden. These clinics provide publicly funded care for conditions such as mood and anxiety disorders, personality difficulties, neurodevelopmental disorders, self-harm, and eating disorders. Patients are typically referred from primary care or via self-referral. All individuals with registered contact and documented treatment activity between 2021 and 2024 at either clinic are included. No direct patient recruitment occurs, as the study is based on anonymized clinical and administrative health record data.
Who may be able to join
- Patient on either of the two units receiving psychotherapy
Who cannot join
- Has a protected identity or protected personal information
Trial locations and contacts
1 site in 1 country.
About this study
Official title: FIT-Implementation Study
This study explores whether the introduction of Feedback-Informed Therapy (FIT) can improve access to psychotherapy within adult psychiatric outpatient care. FIT is a person-centered method where patients regularly provide structured feedback on their progress and therapeutic alliance, allowing treatment to be adjusted or concluded when needed. The purpose of this research is to investigate if implementing FIT results in shorter waiting times, and more efficient use of therapeutic resources.
The project compares two similar psychiatric outpatient clinics in Sweden - one that introduced FIT in 2021 and one that did not. The study uses existing anonymized data from healthcare administrative systems and medical records. No changes are made to patients' treatment, and no new interventions are introduced. The research team will evaluate whether the clinic using FIT shows differences in treatment duration and availability the years 2022-2024.
By examining real-world outcomes, this study aims to determine whether FIT supports increased access to psychotherapy and enhances person-centered care. The results may help healthcare providers and decision-makers improve mental health services and strengthen patient involvement in treatment.
Read the detailed description
This observational study investigates the real-world effects of implementing Feedback-Informed Therapy (FIT) in a general adult psychiatric outpatient setting. FIT is designed to support person-centred care by continuously monitoring patient-reported treatment progress and therapeutic alliance. Through structured feedback, clinicians can adjust interventions or discontinue therapy when improvement is limited. The current project aims to evaluate whether the introduction of FIT influences efficiency and accessibility of psychotherapy services within routine clinical practice.
Two outpatient psychiatric clinics in southern Sweden are compared: one that implemented FIT starting in 2021 and one with standard care and no FIT-based monitoring structure. The study uses retrospective clinical administrative data and medical record information spanning 2021-2024. Data extraction includes diagnostic information, treatment activity codes, number of sessions, waiting times, and therapy initiation and termination dates. Information will be anonymised before analysis, and no patient contact or treatment alteration occurs. Access to source material is conducted using regulated research authorisation procedures.
The primary outcomes are treatment duration (measured as number of sessions) and waiting time to the start of psychotherapy.
The study seeks to determine whether FIT supports improved access and efficiency for therapeutical interventions at the clinic where it has been introduced, compared with routine practice without FIT. Results are expected to provide empirical insight into system-level changes in psychotherapy delivery within public mental health services.
- Conditions
- Psychiatric Diagnosis
- Being tested
- Feedbeack Informed Therapy
- Keywords
- Feedback Informed Therapy, Routine Outcome Monitoring, Psychotherapy, Mental Health Services, Outpatient Psychiatry, Person-Centered Care, Shared Decision-Making
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feedbeack Informed TherapyBehavioural
Feedback-Informed Therapy (FIT) is a structured feedback system integrated into routine psychotherapy at one outpatient psychiatric clinic. Patients complete standardized progress and alliance rating measures at each session, and therapists use this feedback to guide clinical decision-making. Treatment plans may be adjusted or concluded based on the monitored development, allowing for early identification of non-response and collaborative treatment modification.
This intervention differs from standard psychotherapy by incorporating continuous outcome monitoring, shared decision-making, and patient-reported feedback as a core component of each session. FIT was implemented in 2021 at one clinic, while the comparison clinic continued usual treatment without systematic feedback tools. No new treatment modality is added; instead, regular psychotherapy is supported by real-time feedback to optimize treatment duration and therapeutic accessibility.
| Study group | Role | What they receive |
|---|---|---|
| FIT clinic cohort | Patients receiving therapy at the clinic where FIT was implemented Receives: Behavioral: Feedbeack Informed Therapy | |
| Comparison clinic cohort | Patients receiving therapy at a similar outpatient psychiatric clinic where FIT was not implemented |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of therapy
Number of individual therapy sessions of all therapies that started and ended within 2022-2024
Measured: 2022-2024
Secondary outcomes (1)
Waiting time
Number of days from decision to start therapy until actual start of therapy within 2022-2024.
Measured: 2022-2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start1 Sep 2024
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DiagnosisStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magnus Nilsson, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280767
- Sponsor's protocol ID
- Dnr 2024-04178-01
- Acronym
- FIT-ACCESS
- Status last verified
- Sep 2024
- First submitted
- 1 Dec 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will not be shared due to restrictions associated with protected health information and Swedish patient privacy regulations. The study uses anonymized clinical record and administrative data from routine psychiatric care, and re-identification of individuals cannot be fully excluded if datasets were made publicly available. Therefore, IPD will remain secured within the healthcare system and will not be distributed outside the research team.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FIT-Implementation Study
- ClinicalTrials.gov ID
- NCT07280767
- Acronym / sponsor ID
- FIT-ACCESS / Dnr 2024-04178-01
- Conditions
- Psychiatric Diagnosis
- Keywords
- Feedback Informed Therapy, Routine Outcome Monitoring, Psychotherapy, Mental Health Services, Outpatient Psychiatry, Person-Centered Care, Shared Decision-Making
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 12 Dec 2025 (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.
This study explores whether the introduction of Feedback-Informed Therapy (FIT) can improve access to psychotherapy within adult psychiatric outpatient care. FIT is a person-centered method where patients regularly provide structured feedback on their progress and therapeutic alliance, allowing treatment to be adjusted or concluded when needed. The purpose of this research is to investigate if implementing FIT results in shorter waiting times, and more efficient use of therapeutic resources.
The project compares two similar psychiatric outpatient clinics in Sweden - one that introduced FIT in 2021 and one that did not. The study uses existing anonymized data from healthcare administrative systems and medical records. No changes are made to patients' treatment, and no new interventions are introduced. The research team will evaluate whether the clinic using FIT shows differences in treatment duration and availability the years 2022-2024.
By examining real-world outcomes, this study aims to determine whether FIT supports increased access to psychotherapy and enhances person-centered care. The results may help healthcare providers and decision-makers improve mental health services and strengthen patient involvement in treatment.
Detailed description
This observational study investigates the real-world effects of implementing Feedback-Informed Therapy (FIT) in a general adult psychiatric outpatient setting. FIT is designed to support person-centred care by continuously monitoring patient-reported treatment progress and therapeutic alliance. Through structured feedback, clinicians can adjust interventions or discontinue therapy when improvement is limited. The current project aims to evaluate whether the introduction of FIT influences efficiency and accessibility of psychotherapy services within routine clinical practice.
Two outpatient psychiatric clinics in southern Sweden are compared: one that implemented FIT starting in 2021 and one with standard care and no FIT-based monitoring structure. The study uses retrospective clinical administrative data and medical record information spanning 2021-2024. Data extraction includes diagnostic information, treatment activity codes, number of sessions, waiting times, and therapy initiation and termination dates. Information will be anonymised before analysis, and no patient contact or treatment alteration occurs. Access to source material is conducted using regulated research authorisation procedures.
The primary outcomes are treatment duration (measured as number of sessions) and waiting time to the start of psychotherapy.
The study seeks to determine whether FIT supports improved access and efficiency for therapeutical interventions at the clinic where it has been introduced, compared with routine practice without FIT. Results are expected to provide empirical insight into system-level changes in psychotherapy delivery within public mental health services.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FIT clinic cohort | – | Behavioral: Feedbeack Informed TherapyPatients receiving therapy at the clinic where FIT was implemented |
| Comparison clinic cohort | – | –Patients receiving therapy at a similar outpatient psychiatric clinic where FIT was not implemented |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adults receiving psychotherapy at two general psychiatric outpatient clinics in southern Sweden. These clinics provide publicly funded care for conditions such as mood and anxiety disorders, personality difficulties, neurodevelopmental disorders, self-harm, and eating disorders. Patients are typically referred from primary care or via self-referral. All individuals with registered contact and documented treatment activity between 2021 and 2024 at either clinic are included. No direct patient recruitment occurs, as the study is based on anonymized clinical and administrative health record data.
Key inclusion criteria (1 listed)
- Patient on either of the two units receiving psychotherapy
Key exclusion criteria (1 listed)
- Has a protected identity or protected personal information
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 |
|---|---|---|
| Feedbeack Informed TherapyFeedback-Informed Therapy (FIT) is a structured feedback system integrated into routine psychotherapy at one outpatient psychiatric clinic. Patients complete standardized progress and alliance rating measures at each session, and therapists use this feedback to guide clinical decision-making. Treatment plans may be adjusted or concluded based on the monitored development, allowing for early identification of non-response and collaborative treatment modification. This intervention differs from standard psychotherapy by incorporating continuous outcome monitoring, shared decision-making, and patient-reported feedback as a core component of each session. FIT was implemented in 2021 at one clinic, while the comparison clinic continued usual treatment without systematic feedback tools. No new treatment modality is added; instead, regular psychotherapy is supported by real-time feedback to optimize treatment duration and therapeutic accessibility. | Behavioural | FIT clinic cohort |
Primary outcome
Length of therapy
Time frame: 2022-2024
Number of individual therapy sessions of all therapies that started and ended within 2022-2024
1 secondary outcome
Waiting time
Time frame: 2022-2024
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 18 Dec 2025.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be shared due to restrictions associated with protected health information and Swedish patient privacy regulations. The study uses anonymized clinical record and administrative data from routine psychiatric care, and re-identification of individuals cannot be fully excluded if datasets were made publicly available. Therefore, IPD will remain secured within the healthcare system and will not be distributed outside the research team.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Psychiatric Diagnosis, run by Region Skane 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 1 inclusion and 1 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 18 Dec 2025. 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?
Length of therapy (time frame: 2022-2024). 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 18 Dec 2025.