Back to resultsInternet Based Cognitive Behavioral Therapy Effects on Depressive Cognitions and Brain Function (iCBT)
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internet Cognitive Behavioral Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression, Internet Cognitive Behavioral Therapy, fMRI, Neuroimaging
Eligibility Criteria
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
Sites / Locations
- Isabelle Rosso
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Internet Cognitive Behavioral Therapy
Monitored Attention Control
Arm Description
Participants with major depressive disorder receive an 8-week long internet-based cognitive behavioral therapy program.
Participants with major depressive disorder receive no treatment but are monitored closely for 8 weeks. Participants in this arm are offered the treatment at the end of the study.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
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.
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.
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
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01598922
Brief Title
Internet Based Cognitive Behavioral Therapy Effects on Depressive Cognitions and Brain Function
Acronym
iCBT
Official Title
Internet Based Cognitive Behavioral Therapy Effects on Depressive Cognitions and Brain Function
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 2012 (Actual)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
The need for mental health services is high among military personnel but perceived stigma and other barriers prevent many Soldiers from obtaining the help they need. Alternative mental health treatment approaches that mitigate stigma and increase access and compliance are greatly needed. One promising treatment approach that has shown efficacy in preliminary research and which may address issues related to stigma and barriers to care, is internet-based cognitive behavioral therapy (iCBT). Internet-based treatments offer brief, interactive, and structured treatment approaches that can be completed by individuals relatively anonymously, in the convenience and privacy of their own homes, and according to their own schedules. Such interventions could offer Soldiers an alternative treatment method that minimizes stigma by allowing private and quasi-anonymous access to treatment and which minimizes barriers to care by enhancing access and maximizing schedule flexibility.
Emerging evidence suggests that iCBT is a particularly promising and well-accepted approach for treating large numbers of individuals while minimizing cost and clinicians' time demand. The study of internet-based and other computer-assisted therapies is currently in its infancy and most studies still lack sufficient methodological rigor to firmly establish the efficacy and applicability of these approaches. The proposed project will provide the most comprehensive evaluation of iCBT to date by employing functional neuroimaging techniques, neurocognitive testing of implicit negative biases and responses to negative feedback, and assessment of resilience and coping capacities in addition to standard symptom-based outcome measures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Depression, Internet Cognitive Behavioral Therapy, fMRI, Neuroimaging
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
For the clinical trial there were only 2 arms: MDD and MAC. There were no Healthy Controls in the CBT vs attention monitoring trial; both groups were depressed.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Internet Cognitive Behavioral Therapy
Arm Type
Experimental
Arm Description
Participants with major depressive disorder receive an 8-week long internet-based cognitive behavioral therapy program.
Arm Title
Monitored Attention Control
Arm Type
No Intervention
Arm Description
Participants with major depressive disorder receive no treatment but are monitored closely for 8 weeks. Participants in this arm are offered the treatment at the end of the study.
Intervention Type
Behavioral
Intervention Name(s)
Internet Cognitive Behavioral Therapy
Intervention Description
8 weeks of online treatment program
Primary Outcome Measure Information:
Title
Change From Pre-treatment to Post-treatment (10 Weeks), Measured by the Hamilton Rating Scale for Depression, 17 Item Version (HRSD-17).
Description
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.
Time Frame
Measured at the baseline visit and 10 weeks after the baseline visit
Secondary Outcome Measure Information:
Title
Weekly Patient Health Questionnaire (PHQ-9) Score
Description
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
Time Frame
Baseline visit, and 10 weeks after baseline visit
Title
Weekly Kessler Psychological Distress Scale (K-10) Score
Description
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.
Time Frame
Week 10 score
Title
Improvement From Baseline in Brain Functioning on the Emotional Interference Task (EIT) and the Monetary Incentive Delay Task (MID)
Description
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.
Time Frame
baseline, 10 weeks
Title
Change From Baseline in Positive and Negative Affect Scale (PANAS) Score
Description
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.
Time Frame
Baseline visit and 10 weeks after baseline visit
Title
Change From Baseline in Connor Davidson Resilience Scale (CD-RISC) Score
Description
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
Time Frame
Baseline visit, and 10 weeks after baseline visit
Title
Change From Baseline in Modified Erikson Flanker Test
Description
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.
Time Frame
Baseline visit and 10 weeks after baseline visit.
Title
Change From Baseline in Implicit Association Test (IAT)
Description
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
Time Frame
Baseline visit, 10 weeks after baseline visit.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott L Rauch, MD
Organizational Affiliation
Mclean Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Isabelle Rosso
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20183695
Citation
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.
Results Reference
background
PubMed Identifier
15229303
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. doi: 10.1056/NEJMoa040603.
Results Reference
background
PubMed Identifier
20544030
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.
Results Reference
background
PubMed Identifier
28009467
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: 10.1002/da.22590. Epub 2016 Dec 23.
Results Reference
result
PubMed Identifier
29486867
Citation
Webb CA, Olson EA, Killgore WDS, Pizzagalli DA, Rauch SL, Rosso IM. Rostral Anterior Cingulate Cortex Morphology Predicts Treatment Response to Internet-Based Cognitive Behavioral Therapy for Depression. Biol Psychiatry Cogn Neurosci Neuroimaging. 2018 Mar;3(3):255-262. doi: 10.1016/j.bpsc.2017.08.005. Epub 2017 Aug 26.
Results Reference
derived
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Internet Based Cognitive Behavioral Therapy Effects on Depressive Cognitions and Brain Function
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