Major Depressive Disorder
Conditions
Keywords
Depression, Internet Cognitive Behavioral Therapy, fMRI, Neuroimaging
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.
Interventions
BEHAVIORALInternet Cognitive Behavioral Therapy
8 weeks of online treatment program
Sponsors
Mclean Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Pre-treatment to Post-treatment (10 Weeks), Measured by the Hamilton Rating Scale for Depression, 17 Item Version (HRSD-17). | Measured at the baseline visit and 10 weeks after the baseline visit | 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
| Measure | Time frame | Description |
|---|---|---|
| Weekly Kessler Psychological Distress Scale (K-10) Score | Week 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) | baseline, 10 weeks | 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 | Baseline visit and 10 weeks after baseline visit | 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. |
| Weekly Patient Health Questionnaire (PHQ-9) Score | Baseline visit, and 10 weeks after baseline visit | 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 |
| Change From Baseline in Modified Erikson Flanker Test | Baseline visit and 10 weeks after baseline visit. | 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) | Baseline visit, 10 weeks after baseline visit. | 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 |
| Change From Baseline in Connor Davidson Resilience Scale (CD-RISC) Score | Baseline visit, and 10 weeks after baseline visit | 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 |
Countries
United States
Participant flow
Pre-assignment details
Healthy control subjects were not part of the clinical trial (they were not assigned to treatment).
Participants by arm
| Arm | Count |
|---|---|
| Internet Cognitive Behavioral Therapy Participants with major depressive disorder who received a 10-week period of internet-based cognitive behavior therapy (iCBT): 6 online lessons and homework. They also received weekly check-in phone calls, and completed online depression rating scales. | 37 |
| Monitored Attention Control Participants with major depressive disorder who received no treatment. These participants logged into the online system the same number of times (6) to complete the same depression self-report scales as participants in the treatment group. They also received the same weekly check-in phone calls as the treatment group during the 10-week period. Participants in this arm were offered the iCBT treatment at the end of the study | 40 |
| Total | 77 |
Baseline characteristics
| Characteristic | Internet Cognitive Behavioral Therapy | Total | Monitored Attention Control |
|---|---|---|---|
| Age, Continuous | 29.2 years STANDARD_DEVIATION 7.7 | 29.0 years STANDARD_DEVIATION 7.2 | 28.8 years STANDARD_DEVIATION 6.7 |
| Education | 15.4 Years STANDARD_DEVIATION 2.5 | 15.4 Years STANDARD_DEVIATION 2.3 | 15.3 Years STANDARD_DEVIATION 2 |
| Employed outside the home | 28 Participants | 52 Participants | 24 Participants |
| Hamilton Rating Scale for Depression, 17 items | 15.7 units on a scale STANDARD_DEVIATION 4 | 15.7 units on a scale STANDARD_DEVIATION 4.2 | 15.7 units on a scale STANDARD_DEVIATION 4.3 |
| Kessler Distress, 10 items | 28.9 units on a scale STANDARD_DEVIATION 5.4 | 29.9 units on a scale STANDARD_DEVIATION 5 | 30.8 units on a scale STANDARD_DEVIATION 4.5 |
| Marital status, married | 5 Participants | 13 Participants | 8 Participants |
| Patient Health Questionnaire, 9 items | 13.9 units on a scale STANDARD_DEVIATION 3.9 | 14.8 units on a scale STANDARD_DEVIATION 4 | 15.6 units on a scale STANDARD_DEVIATION 4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 11 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 11 Participants | 5 Participants |
| Race (NIH/OMB) White | 23 Participants | 48 Participants | 25 Participants |
| Sex: Female, Male Female | 23 Participants | 53 Participants | 30 Participants |
| Sex: Female, Male Male | 14 Participants | 24 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 37 | 0 / 40 |
| serious Total, serious adverse events | 0 / 37 | 0 / 40 |
Outcome results
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.
Time frame: Measured at the baseline visit and 10 weeks after the baseline visit
Population: Note that these are sample sizes.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internet Cognitive Behavioral Therapy | Change From Pre-treatment to Post-treatment (10 Weeks), Measured by the Hamilton Rating Scale for Depression, 17 Item Version (HRSD-17). | Pre-treatment HRSD-17 | 15.73 score on a scale | Standard Deviation 4.02 |
| Internet Cognitive Behavioral Therapy | Change From Pre-treatment to Post-treatment (10 Weeks), Measured by the Hamilton Rating Scale for Depression, 17 Item Version (HRSD-17). | Post-treatment HRSD-17 | 9.17 score on a scale | Standard Deviation 6.92 |
| Monitored Attention Control | Change From Pre-treatment to Post-treatment (10 Weeks), Measured by the Hamilton Rating Scale for Depression, 17 Item Version (HRSD-17). | Pre-treatment HRSD-17 | 15.70 score on a scale | Standard Deviation 4.26 |
| Monitored Attention Control | Change From Pre-treatment to Post-treatment (10 Weeks), Measured by the Hamilton Rating Scale for Depression, 17 Item Version (HRSD-17). | Post-treatment HRSD-17 | 14.05 score on a scale | Standard Deviation 5.34 |
p-value: <0.000195% CI: [2.814, 9.403]GENLIN
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
Time frame: Baseline visit, and 10 weeks after baseline visit
Population: Data not analyzed due to funding ending for this study.
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
Time frame: Baseline visit, 10 weeks after baseline visit.
Population: Data not analyzed due to funding ending.
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.
Time frame: Baseline visit and 10 weeks after baseline visit.
Population: Data still being analyzed and not analysis/paper not anticipated to be completed until January 2022
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.
Time frame: Baseline visit and 10 weeks after baseline visit
Population: Data not analyzed due to funding ending for this study
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.
Time frame: baseline, 10 weeks
Population: Analysis still ongoing, anticipated until January 2022
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.
Time frame: Week 10 score
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Internet Cognitive Behavioral Therapy | Weekly Kessler Psychological Distress Scale (K-10) Score | 20.14 units on a scale | Standard Deviation 7.37 |
| Monitored Attention Control | Weekly Kessler Psychological Distress Scale (K-10) Score | 26.73 units on a scale | Standard Deviation 6.55 |
Comparison: The Kessler Psychological Distress Scale (K-10) is a 10-item scale with total scores that can range from 0 to 50. Higher scores represent worse (more severe) psychological distress.p-value: 0.00395% CI: [-1.42, -0.48]HLM
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
Time frame: Baseline visit, and 10 weeks after baseline visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Internet Cognitive Behavioral Therapy | Weekly Patient Health Questionnaire (PHQ-9) Score | 9.17 score on a scale | Standard Deviation 6.92 |
| Monitored Attention Control | Weekly Patient Health Questionnaire (PHQ-9) Score | 14.05 score on a scale | Standard Deviation 5.34 |
p-value: 0.02495% CI: [-1.25, -0.32]hierarchical linear modeling