NCT07280767

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
213

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 1, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 12, 2025

Completed
Last Updated

December 18, 2025

Status Verified

September 1, 2024

Enrollment Period

1.2 years

First QC Date

December 1, 2025

Last Update Submit

December 11, 2025

Conditions

Keywords

Feedback Informed TherapyRoutine Outcome MonitoringPsychotherapyMental Health ServicesOutpatient PsychiatryPerson-Centered CareShared Decision-Making

Outcome Measures

Primary Outcomes (1)

  • Length of therapy

    Number of individual therapy sessions of all therapies that started and ended within 2022-2024

    2022-2024

Secondary Outcomes (1)

  • Waiting time

    2022-2024

Study Arms (2)

FIT clinic cohort

Patients receiving therapy at the clinic where FIT was implemented

Behavioral: Feedbeack Informed Therapy

Comparison clinic cohort

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

Interventions

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.

FIT clinic cohort

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Patient on either of the two units receiving psychotherapy

You may not qualify if:

  • Has a protected identity or protected personal information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Verksamhetsområde Vuxenpsykiatri Lund

Lund, Skåne County, 22185, Sweden

Location

MeSH Terms

Conditions

Mental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

December 1, 2025

First Posted

December 12, 2025

Study Start

September 1, 2024

Primary Completion

November 30, 2025

Study Completion

November 30, 2025

Last Updated

December 18, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

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.

Locations