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

NCT04191811 · tracked via the Priya Life Science Sweden tracker

Sponsor

Karolinska Institutet

Phase

Observational

Started

2022-04-01

Last updated

2025-10-07

Condition(s) studied

Psychiatric DisorderDepressionAnxiety DisordersInsomnia

Investigational drug(s) / intervention(s)

Internet-delivered cognitive behavioral therapy for major depressive disorderInternet-delivered cognitive behavioral therapy for insomniaInternet-delivered cognitive behavioral therapy for social anxiety disorder

Internet-delivered cognitive behavioral therapy for major depressive disorder: Cognitive behavioral therapy delivered over a period of 12 weeks, guided by a psychologist who provides written feedback on home assignments and questions.

Internet-delivered cognitive behavioral therapy for insomnia: Cognitive behavioral therapy delivered over a period of 12 weeks, guided by a psychologist who provides written feedback on home assignments and questions.

Internet-delivered cognitive behavioral therapy for social anxiety disorder: Cognitive behavioral therapy delivered over a period of 12 weeks, guided by a psychologist who provides written feedback on home assignments and questions.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Accepted

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)"?

Primary outcome measure(s)

Change from Baseline Patient Health Questionnaire 9 - Self Assessment (PHQ-9) to Post-treatment — Up to 6 months
The questionnaire has nine items. Overall score ranges from 0 to 27. Lower scores indicates a better outcome.
Change from Baseline Insomnia Severity Index - Self Assessment (ISI) to Post-treatment — Up to 6 months
The questionnaire has seven items. The overall score ranges from 0 to 28. Lower scores indicates a better outcome.
Change from Baseline Liebowitz Social Anxiety Scale - Self Assessment (LSAS-SR) to Post-treatment — Up to 6 months
The questionnaire has 48 items. The overall score ranges from 0 to 144. Lower scores indicates a better outcome.

Trial sites (1)

Facility	City	Region	Status
Internetpsykiatri	Huddinge	Stockholm County	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04191811 on ClinicalTrials.gov ↗ ← All trials in Sweden