Major Depressive Disorder Clinical Trial
— iCBTOfficial title:
Internet Based Cognitive Behavioral Therapy Effects on Depressive Cognitions and Brain Function
Verified date | May 2021 |
Source | Mclean Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to understand the effectiveness of a ten-week internet-based cognitive behavioral therapy (iCBT) treatment on improving depressive symptoms, coping and resilience skills, and cognitive processing.
Status | Completed |
Enrollment | 77 |
Est. completion date | August 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion criteria: - Age range between 18 and 45. - Subjects must be right handed (as measured by Edinburgh Handedness Inventory). - The primary language of the subjects must be English - Must have regular access to a computer with internet connection and printer (for potential MDD or MAC participants) - DSM-IV criteria for current Major Depressive Episode according to SCID (for enrollment into MDD or MAC groups) - Absence of any psychotropic medications for at least 2 weeks (6 weeks for fluoxetine; 6 months for neuroleptics; 2 weeks for benzodiazepines; 2 weeks for any other antidepressants) - PHQ-9 score below 5 (for enrollment into HC group) Exclusion criteria: - Any history of neurological illness or brain injury - Current or past DSM-IV Axis I disorder (for enrollment into HC group) - Complicating medical conditions that may influence the outcome of neuropsychological assessment or functional imaging (e.g., HIV) - Mixed or left-handedness - Abnormal visual acuity that is not corrected by contact lenses - Metal within the body, claustrophobia, or other contraindications for MRI - Less than 9th grade education - Past or current alcohol/substance dependence, or current alcohol abuse, or current or past substance abuse (i.e. past alcohol abuse is not exclusionary) - Use of illicit drugs within the past year - Use of marijuana within the past month - Current use of opioid or prescribed stimulant medications - History of a psychotic mental illness (schizophrenia or bipolar disorder) - Current severe symptoms of depression (total score > 23 or responding > 1 to Question 9 for suicidal ideation in the Patient Health Questionnaire-9 Item [PHQ-9] (Kroenke et al., 2001)) - A PHQ-9 score below 10 (for potential MDD or MAC participants) - Currently participating in Cognitive Behavior Therapy - History of ECT treatment |
Country | Name | City | State |
---|---|---|---|
United States | Isabelle Rosso | Belmont | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Mclean Hospital |
United States,
Andersson G, Cuijpers P. Internet-based and other computerized psychological treatments for adult depression: a meta-analysis. Cogn Behav Ther. 2009;38(4):196-205. doi: 10.1080/16506070903318960. — View Citation
Hoge CW, Castro CA, Messer SC, McGurk D, Cotting DI, Koffman RL. Combat duty in Iraq and Afghanistan, mental health problems, and barriers to care. N Engl J Med. 2004 Jul 1;351(1):13-22. — View Citation
Rosso IM, Killgore WD, Olson EA, Webb CA, Fukunaga R, Auerbach RP, Gogel H, Buchholz JL, Rauch SL. Internet-based cognitive behavior therapy for major depressive disorder: A randomized controlled trial. Depress Anxiety. 2017 Mar;34(3):236-245. doi: 10.100 — View Citation
Titov N, Andrews G, Davies M, McIntyre K, Robinson E, Solley K. Internet treatment for depression: a randomized controlled trial comparing clinician vs. technician assistance. PLoS One. 2010 Jun 8;5(6):e10939. doi: 10.1371/journal.pone.0010939. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Pre-treatment to Post-treatment (10 Weeks), Measured by the Hamilton Rating Scale for Depression, 17 Item Version (HRSD-17). | To assess change in severity of depression symptoms. The total score is reported, which is the sum of the ratings of all items and ranges from 0 to 52, with higher scores indicating a worse outcome or greater severity of depression symptoms. | Measured at the baseline visit and 10 weeks after the baseline visit | |
Secondary | Weekly Patient Health Questionnaire (PHQ-9) Score | Participants' scores on the PHQ-9 will be measured at baseline before treatment, each week during the treatment, and again at 10 weeks post-treatment. The range of possible scores on the PHQ-9 is 0 to 27 and higher scores indicate worse outcome or more severe depression | Baseline visit, and 10 weeks after baseline visit | |
Secondary | Weekly Kessler Psychological Distress Scale (K-10) Score | The K-10 is a 10-item self-report measure of psychological distress. Items are scored on a scale from 1" ("none of the time") to "5" ("all of the time"). Total K-10 scores range from 10 to 50, with higher scores reflecting worse outcome or higher distress. | Week 10 score | |
Secondary | Improvement From Baseline in Brain Functioning on the Emotional Interference Task (EIT) and the Monetary Incentive Delay Task (MID) | At 10 weeks (post-treatment), we will look for improvement from baseline in key brain regions known to be affected by depression. Differences in EIT and MID task-related brain responses will be measured. | baseline, 10 weeks | |
Secondary | Change From Baseline in Positive and Negative Affect Scale (PANAS) Score | Participants' scores on the PANAS will be measured at baseline before treatment, and again at 10 weeks post-treatment. Two scores can be derived. 1) A positive affect score can range from 10 to 50, with higher scores representing better outcome or higher levels of positive affect; 2) Negative Affect score can range from 10 to 50, with higher scores representing better outcome or lower levels of negative affect. | Baseline visit and 10 weeks after baseline visit | |
Secondary | Change From Baseline in Connor Davidson Resilience Scale (CD-RISC) Score | Participants' scores on the CD-RISC will be measured at baseline before treatment, and again at 10 weeks post-treatment. Total scores range from 0 to 100, with higher scores indicating a better outcome or higher resilience | Baseline visit, and 10 weeks after baseline visit | |
Secondary | Change From Baseline in Modified Erikson Flanker Test | Participants' scores on the Modified Erikson Flanker Test will be measured at baseline before treatment, and again at 10 weeks post-treatment. Accuracy scores range from 0 to 1 with higher scores reflecting better outcome. | Baseline visit and 10 weeks after baseline visit. | |
Secondary | Change From Baseline in Implicit Association Test (IAT) | Participants' scores on the IAT will be measured at baseline before treatment, and again at 10 weeks post-treatment. The IAT effect is called the D score with a possible range of -2 to +2, with larger scores reflecting worse outcome and stronger suicidality | Baseline visit, 10 weeks after baseline visit. |
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