Investigating brain response variability to predict success in online therapy for mental health

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to explore how moment-to-moment variability in brain responses, measured through BOLD-fMRI, can predict the success of internet-delivered cognitive behavioral therapy (iCBT) for conditions such as depression, anxiety, and insomnia. By comparing objective brain function measurements with subjective patient experiences, the researchers hope to develop a more accurate prediction model for treatment outcomes. The study will involve 225 participants, including healthy controls, to better understand the neurobiological factors influencing mental health treatment effectiveness.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Meeting DSM-5 criteria for depression, social anxiety or insomnia. Diagnosis and measures of symptom burden and functional level are made through a structured interview, the Mini-International Neuropsychiatric Interview (M.I.N.I.) and self-assessments of symptoms. Healthy controls should not be relevant to psychiatric treatment nor meet criteria for any psychiatric condition according to the M.I.N.I.
* Being able to read, write and speak Swedish in order to be able to read the treatment texts and be able to make phone calls.
* Having basic computer skills to be able to complete surveys via the Internet and access the treatment platform.

Exclusion Criteria:

* Physical or mental illnesses who are either contraindicated for treatment (for example, bipolar disorder that can be exacerbated by treatment) or for other reasons need other treatments (e.g. severe depression, suicidal behavior, psychotic illnesses or extensive cognitive difficulties).
* High alcohol consumption or other ongoing drug use.
* Answering "yes" to any of the following questions will be excluded for participation: 1) "Have you or have you had any electrical / battery operated implants in your body? For example, a pacemaker, medication pump, neurostimulator, hearing implant, or other electrical / battery controlled implant?" 2) "Have you done any surgery on the abdomen, chest, heart or brain, eyes, ears? For example, vessel clips, or objects such as screws, heart valve, shunt or prosthesis?" 3) "Do you have or have you had any metallic object in your body?" 4) "If a woman, are you pregnant or breastfeeding?" 5) "Do you undergo dialysis or have kidney dysfunction?" Participants who answer yes to these follow-up questions will be interviewed more closely to determine if MRI security can be guaranteed and whether the MRI signal will have significant disruptions, for example due to dental scaffolding. 1) "If you have any abdominal, thoracic, heart or brain, eyes, ears? Do you have any inoperable object that has ferromagnetic properties?" The patient will be asked to consult his doctor about this. 2) "If you have a dental rack, what type of dental rack (fixed or removable, metal plates / rails or wire)"?

Where it's running

• Internetpsykiatri
  Huddinge, Stockholm County, Sweden Recruiting

Study contacts

• Principal investigator: Kristoffer Kristoffer, PhD — Department of Clinical Neuroscience, Karolinska Institutet
• Study coordinator: Kristoffer Kristoffer, PhD
• Email: kristoffer.mansson@ki.se
• Phone: +46(0)705803267

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.