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

Completed

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

Observational

Enrollment (Actual)

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

    • 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

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
Intervention / Treatment
FIT clinic cohort
Patients receiving therapy at the clinic where FIT was implemented

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

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

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

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)

September 1, 2024

Primary Completion (Actual)

November 30, 2025

Study Completion (Actual)

November 30, 2025

Study Registration Dates

First Submitted

December 1, 2025

First Submitted That Met QC Criteria

December 1, 2025

First Posted (Estimated)

December 12, 2025

Study Record Updates

Last Update Posted (Actual)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

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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