Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT04191811

Investigating Neural Response Variability as a Single-patient Predictor of Successful CBT in Clinical Psychiatry

Led by Karolinska Institutet · Updated on 2025-10-07

150

Participants Needed

1

Research Sites

195 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Many psychiatric patients are not sufficiently improved by current interventions. Functional magnetic imaging brain imaging (fMRI) has proven to be a promising method for predicting treatment outcomes in psychiatric treatment. Individuals moment-to-moment variability have not yet been evaluated as a predictor of treatment of three common forms of mental illness: depression, insomnia and health anxiety. The goal is to investigate whether objective measurements of brain function contribute to a better prediction of a patient's success in treatment than experiences and self-reports, e.g., treatment credibility and patients expectations about the treatment. The prediction model will be tested on internet-delivered CBT (iCBT) for depression, insomnia and social anxiety. Patients in each diagnostic group are asked for participation before treatment. The total number of participants in this study will amount to 225 participants. The goal is that 35% consists of healthy controls and that the remaining part is equally distributed between the three diagnostic patient groups. Being able to better predict how well a psychiatric treatment will work for an individual has great value from both an economic and a treatment perspective. The findings from this study may contribute to increased knowledge about neurobiological complications in mental illness. In the longer term, it can lead to improved routines and help in clinical decision-making when patients should be recommended treatment.

CONDITIONS

Official Title

Investigating Neural Response Variability as a Single-patient Predictor of Successful CBT in Clinical Psychiatry

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Meeting DSM-5 criteria for depression, social anxiety, or insomnia confirmed by structured interview and self-assessment
  • Healthy controls must not have any psychiatric condition according to structured interview
  • Able to read, write, and speak Swedish
  • Basic computer skills to complete internet surveys and access treatment platform
Not Eligible

You will not qualify if you...

  • Having physical or mental illnesses contraindicated for treatment or requiring other treatments, such as bipolar disorder, severe depression, suicidal behavior, psychotic illnesses, or significant cognitive difficulties
  • High alcohol consumption or ongoing drug use
  • Having electrical or battery-operated implants like pacemakers, medication pumps, neurostimulators, or hearing implants
  • History of surgery on abdomen, chest, heart, brain, eyes, or ears with implanted metallic objects
  • Pregnant or breastfeeding women
  • Undergoing dialysis or having kidney dysfunction
  • Having inoperable ferromagnetic objects or certain types of dental scaffolding that interfere with MRI safety and signals

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Internetpsykiatri

Huddinge, Stockholm County, Sweden, 14152

Actively Recruiting

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Research Team

K

Kristoffer Kristoffer, PhD

CONTACT

V

Viktor Kaldo, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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