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

NCT04191811 | Recruiting

• 1 other identifier: 2021-06396-0
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psychiatric Disorder; Depression; Anxiety Disorders; Insomnia

Keywords

Internet-delivered Cognitive Behavior Therapy; BOLD-fMRI; Moment-to-moment variability

Outcome Measures

Primary Outcomes (3)

• 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.

  Up to 6 months

• 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.

  Up to 6 months

• 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.

  Up to 6 months

Secondary Outcomes (5)

• Consultation Satisfaction Questionnaire (CSQ-8) to Post-treatment

  3 months

• Social Phobia Inventory - Self Assessment (SPIN) 17 items. Overall score 0-68.

  Up to 6 months

• World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)

  Up to 6 months

• Change from Baseline Generalized Anxiety Disorder Scale (GAD-7) to Post-treatment

  Up to 6 months

• Montgomery Åsberg Depression Rating Scale - Self Assessment (MADRS-S)

  Up to 6 months

Study Arms (3)

Depression Internet-delivered CBT

12 weeks of guided internet-delivered CBT for depression.

Behavioral: Internet-delivered cognitive behavioral therapy for major depressive disorder

Insomnia Internet-delivered CBT

12 weeks of guided internet-delivered CBT for insomnia.

Behavioral: Internet-delivered cognitive behavioral therapy for insomnia

Social Anxiety Internet-delivered CBT

12 weeks of guided internet-delivered CBT for social anxiety.

Behavioral: Internet-delivered cognitive behavioral therapy for social anxiety disorder

Interventions

Internet-delivered cognitive behavioral therapy for major depressive disorder BEHAVIORAL

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

Depression Internet-delivered CBT

Internet-delivered cognitive behavioral therapy for insomnia BEHAVIORAL

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

Insomnia Internet-delivered CBT

Internet-delivered cognitive behavioral therapy for social anxiety disorder BEHAVIORAL

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

Social Anxiety Internet-delivered CBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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).

You may qualify if:

• 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.

You may not qualify if:

• 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)"?

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Internetpsykiatri

Huddinge, Stockholm County, 14152, Sweden

RECRUITING

Related Publications (11)

• Schwiedrzik CM, Melloni L, Schurger A. Mooney face stimuli for visual perception research. PLoS One. 2018 Jul 6;13(7):e0200106. doi: 10.1371/journal.pone.0200106. eCollection 2018.

  PMID: 29979727 BACKGROUND

• Wandell BA, Dumoulin SO, Brewer AA. Visual field maps in human cortex. Neuron. 2007 Oct 25;56(2):366-83. doi: 10.1016/j.neuron.2007.10.012.

  PMID: 17964252 BACKGROUND

• Hariri AR, Mattay VS, Tessitore A, Kolachana B, Fera F, Goldman D, Egan MF, Weinberger DR. Serotonin transporter genetic variation and the response of the human amygdala. Science. 2002 Jul 19;297(5580):400-3. doi: 10.1126/science.1071829.

  PMID: 12130784 BACKGROUND

• Wang S, Yu R, Tyszka JM, Zhen S, Kovach C, Sun S, Huang Y, Hurlemann R, Ross IB, Chung JM, Mamelak AN, Adolphs R, Rutishauser U. The human amygdala parametrically encodes the intensity of specific facial emotions and their categorical ambiguity. Nat Commun. 2017 Apr 21;8:14821. doi: 10.1038/ncomms14821.

  PMID: 28429707 BACKGROUND

• Garrett DD, Kovacevic N, McIntosh AR, Grady CL. Blood oxygen level-dependent signal variability is more than just noise. J Neurosci. 2010 Apr 7;30(14):4914-21. doi: 10.1523/JNEUROSCI.5166-09.2010.

  PMID: 20371811 BACKGROUND

• Garrett DD, Nagel IE, Preuschhof C, Burzynska AZ, Marchner J, Wiegert S, Jungehulsing GJ, Nyberg L, Villringer A, Li SC, Heekeren HR, Backman L, Lindenberger U. Amphetamine modulates brain signal variability and working memory in younger and older adults. Proc Natl Acad Sci U S A. 2015 Jun 16;112(24):7593-8. doi: 10.1073/pnas.1504090112. Epub 2015 Jun 1.

  PMID: 26034283 BACKGROUND

• Mansson KN, Frick A, Boraxbekk CJ, Marquand AF, Williams SC, Carlbring P, Andersson G, Furmark T. Predicting long-term outcome of Internet-delivered cognitive behavior therapy for social anxiety disorder using fMRI and support vector machine learning. Transl Psychiatry. 2015 Mar 17;5(3):e530. doi: 10.1038/tp.2015.22.

  PMID: 25781229 BACKGROUND

• Hedman E, Ljotsson B, Kaldo V, Hesser H, El Alaoui S, Kraepelien M, Andersson E, Ruck C, Svanborg C, Andersson G, Lindefors N. Effectiveness of Internet-based cognitive behaviour therapy for depression in routine psychiatric care. J Affect Disord. 2014 Feb;155:49-58. doi: 10.1016/j.jad.2013.10.023. Epub 2013 Oct 26.

  PMID: 24238951 BACKGROUND

• Blom K, Jernelov S, Kraepelien M, Bergdahl MO, Jungmarker K, Ankartjarn L, Lindefors N, Kaldo V. Internet treatment addressing either insomnia or depression, for patients with both diagnoses: a randomized trial. Sleep. 2015 Feb 1;38(2):267-77. doi: 10.5665/sleep.4412.

  PMID: 25337948 BACKGROUND

• Hedman E, Andersson E, Ljotsson B, Axelsson E, Lekander M. Cost effectiveness of internet-based cognitive behaviour therapy and behavioural stress management for severe health anxiety. BMJ Open. 2016 Apr 25;6(4):e009327. doi: 10.1136/bmjopen-2015-009327.

  PMID: 27113231 BACKGROUND

• Mansson KNT, Waschke L, Manzouri A, Furmark T, Fischer H, Garrett DD. Moment-to-Moment Brain Signal Variability Reliably Predicts Psychiatric Treatment Outcome. Biol Psychiatry. 2022 Apr 1;91(7):658-666. doi: 10.1016/j.biopsych.2021.09.026. Epub 2021 Oct 12.

  PMID: 34961621 BACKGROUND

MeSH Terms

Conditions

Mental Disorders; Depression; Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Kristoffer Kristoffer, PhD

  Department of Clinical Neuroscience, Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristoffer Kristoffer, PhD

CONTACT

+46(0)705803267; kristoffer.mansson@ki.se

Viktor Kaldo, PhD

CONTACT

viktor.kaldo@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 10, 2019
• Study Start: April 1, 2022
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-03

Locations

SE (1)