Investigating brain response variability to predict success in online therapy for mental health
Moment-to-moment Neural Variability as a Predictor of Treatment Outcome in Patients With Common Psychiatric Disorders: Major Depressive Disorder, Insomnia and Social Anxiety Disorder
This study is testing if changes in brain activity can help predict how well online therapy works for people with depression, anxiety, and insomnia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Huddinge, Stockholm County) |
| Trial ID | NCT04191811 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals meeting DSM-5 criteria for depression, social anxiety, or insomnia who can read and write in Swedish.
Not a fit: Patients with severe mental illnesses, such as bipolar disorder or psychotic disorders, may not benefit from this study due to contraindications for treatment.
Why it matters
Potential benefit: If successful, this study could lead to improved prediction of treatment outcomes for patients undergoing online therapy, enhancing personalized treatment approaches.
How similar studies have performed: Preliminary data suggest that similar approaches using brain imaging to predict treatment outcomes have shown promise, indicating potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Huddinge, Stockholm County
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.