Investigating Neural Response Variability as a Single-patient Predictor of Successful CBT in Clinical Psychiatry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKarolinska Institutet
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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)"?
Trial population
Reported in previous studies from the clinic: * Depression: mean age 37.9 (SD=11.8) yrs, 33% males, time since symptom debut, years 10.4 (SD=9.9), baseline MADRS-S scores 25.13 (SD=6.67); 72% on current psychotropic medication. * Insomnia: mean age 46.1 (SD=13.6) yrs, 70% males, baseline ISI scores 20.4 (SD=3.7); baseline MADRS-S score 25.5 (SD=6.8), 72% on current sleep medication 64%, on antidepressant medication 36%. * Social anxiety: mean age 32.51 (SD=8.98), 54% males, baseline LSAS-SR score 71.23 (SD=24.57), time since symptom debut, years 15.95 (SD=10.99), on current psychotropic medication 68% (SD=0.47).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Internet-delivered cognitive behavioral therapy for major depressive disorder
BehavioralCognitive 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
BehavioralCognitive 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
BehavioralCognitive behavioral therapy delivered over a period of 12 weeks, guided by a psychologist who provides written feedback on home assignments and questions.
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: Depression Internet-delivered CBT1 intervention
Group B: Insomnia Internet-delivered CBT1 intervention
Group C: Social Anxiety Internet-delivered CBT1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline Patient Health Questionnaire 9 - Self Assessment (PHQ-9) to Post-treatment
The questionnaire has nine items. Overall score ranges from 0 to 27. Lower scores indicates a better outcome.
Time frame
Up to 6 months2
Change from Baseline Insomnia Severity Index - Self Assessment (ISI) to Post-treatment
The questionnaire has seven items. The overall score ranges from 0 to 28. Lower scores indicates a better outcome.
Time frame
Up to 6 months3
Change from Baseline Liebowitz Social Anxiety Scale - Self Assessment (LSAS-SR) to Post-treatment
The questionnaire has 48 items. The overall score ranges from 0 to 144. Lower scores indicates a better outcome.
Time frame
Up to 6 monthsSecondary outcomes
1
Consultation Satisfaction Questionnaire (CSQ-8) to Post-treatment
The questionnaire has 8 items. The overall score ranges from 8 to 32. Higher scores indicate a better outcome.
Time frame
3 months2
Social Phobia Inventory - Self Assessment (SPIN) 17 items. Overall score 0-68.
Self Assessment, 17 items. Overall score 0-68. Lower scores indicates a better outcome.
Time frame
Up to 6 months3
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Self Assessment, 12 items. Overall score 0-100%. Lower scores indicate a better outcome.
Time frame
Up to 6 months4
Change from Baseline Generalized Anxiety Disorder Scale (GAD-7) to Post-treatment
The questionnaire has seven items. The overall score ranges from 0 to 21. Lower scores indicate a better outcome.
Time frame
Up to 6 monthsSponsors and contacts
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Source ClinicalTrials.gov