Does Implementation of Feedback Informed Therapy (FIT) Improve Access to Psychotherapy in Psychiatry? (FIT-ACCESS)

December 11, 2025 updated by: Magnus Nilsson, Region Skane

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
213

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Skåne County
      • Lund, Skåne County, Sweden, 22185
        • Verksamhetsområde Vuxenpsykiatri Lund

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • Patient on either of the two units receiving psychotherapy

Exclusion Criteria:

  • Has a protected identity or protected personal information

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
FIT clinic cohort
Patients receiving therapy at the clinic where FIT was implemented
Behavioral: Feedbeack Informed Therapy

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.
Comparison clinic cohort
Patients receiving therapy at a similar outpatient psychiatric clinic where FIT was not implemented

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Length of therapy
Time Frame: 2022-2024
Number of individual therapy sessions of all therapies that started and ended within 2022-2024
2022-2024

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Waiting time
Time Frame: 2022-2024
Number of days from decision to start therapy until actual start of therapy within 2022-2024.
2022-2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Region Skane

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 12, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Dnr 2024-04178-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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