Major Depressive DisorderiCBTNCT01598922
Internet Based Cognitive Behavioral Therapy Effects on Depressive Cognitions and Brain Function
A study testing Internet Cognitive Behavioral Therapy in people with Major Depressive Disorder, run by Mclean Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Internet Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Aug 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Internet Cognitive Behavioral Therapy
- Keywords
- Depression, Internet Cognitive Behavioral Therapy, fMRI, Neuroimaging
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet Cognitive Behavioral TherapyBehavioural
8 weeks of online treatment program
| Study group | Role | What they receive |
|---|---|---|
| Internet Cognitive Behavioral Therapy | Experimental | Participants with major depressive disorder receive an 8-week long internet-based cognitive behavioral therapy program. Receives: Behavioral: Internet Cognitive Behavioral Therapy |
| Monitored Attention Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at the baseline visit and 10 weeks after the baseline visit
Secondary outcomes (7)
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
Measured: Baseline visit, and 10 weeks after baseline visit
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.
Measured: Week 10 score
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.
Measured: baseline, 10 weeks
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.
Measured: Baseline visit and 10 weeks after baseline visit
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
Measured: Baseline visit, and 10 weeks after baseline visit
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.
Measured: Baseline visit and 10 weeks after baseline visit.
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
Measured: Baseline visit, 10 weeks after baseline visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startOct 2012
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Rauch, Mclean Hospital
- Investigators
- Scott L Rauch, MD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598922
- Sponsor's protocol ID
- W81XWH-12-1-0109
- Acronym
- iCBT
- Status last verified
- May 2021
- First submitted
- 11 May 2012
- Last updated
- 25 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 20183695Hoge 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.
PubMed 15229303Titov 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.
PubMed 20544030Rosso 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.
PubMed 28009467Webb 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.
PubMed 29486867
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet Based Cognitive Behavioral Therapy Effects on Depressive Cognitions and Brain Function
- ClinicalTrials.gov ID
- NCT01598922
- Acronym / sponsor ID
- iCBT / W81XWH-12-1-0109
- Conditions
- Major Depressive Disorder
- Keywords
- Depression, Internet Cognitive Behavioral Therapy, fMRI, Neuroimaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- Oct 2012 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 15 May 2012 (estimated)
- Results
- Posted 7 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Internet Cognitive Behavioral Therapy | Experimental | Behavioral: Internet Cognitive Behavioral TherapyParticipants with major depressive disorder receive an 8-week long internet-based cognitive behavioral therapy program. |
| Monitored Attention Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet Cognitive Behavioral Therapy8 weeks of online treatment program | Behavioural | Internet Cognitive Behavioral Therapy |
Primary outcome
Change From Pre-treatment to Post-treatment (10 Weeks), Measured by the Hamilton Rating Scale for Depression, 17 Item Version (HRSD-17).
Time frame: 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.
7 secondary outcomes
Weekly Patient Health Questionnaire (PHQ-9) Score
Time frame: Baseline visit, and 10 weeks after baseline visit
Weekly Kessler Psychological Distress Scale (K-10) Score
Time frame: Week 10 score
Improvement From Baseline in Brain Functioning on the Emotional Interference Task (EIT) and the Monetary Incentive Delay Task (MID)
Time frame: baseline, 10 weeks
Change From Baseline in Positive and Negative Affect Scale (PANAS) Score
Time frame: Baseline visit and 10 weeks after baseline visit
Change From Baseline in Connor Davidson Resilience Scale (CD-RISC) Score
Time frame: Baseline visit, and 10 weeks after baseline visit
Change From Baseline in Modified Erikson Flanker Test
Time frame: Baseline visit and 10 weeks after baseline visit.
Change From Baseline in Implicit Association Test (IAT)
Time frame: Baseline visit, 10 weeks after baseline visit.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20183695Andersson 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.
- Background: PubMed 15229303Hoge 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.
- Background: PubMed 20544030Titov 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 publication: PubMed 28009467Rosso 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.
- Derived from this study: PubMed 29486867Webb 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.
Related trials for Major Depressive Disorder
RecruitingPhase 1
Open-Label Psilocybin Study in Transdiagnostic Population
Transdiagnostic, Depression - Major Depressive Disorder
Not yet recruitingPhase 2
Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
PTSD, PTSD - Post Traumatic Stress Disorder
RecruitingPhase 2
A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)
Major Depressive Episode (MDE), Major Depressive Disorder (MDD)
RecruitingPhase 1
Mechanism of Action Underlying Ketamine's Antidepressant Effects: The AMPA Throughput Theory in Patients With Treatment-Resistant Major Depression
Depression, Major Depressive Disorder
Not yet recruiting
Acceptance and Committment Therapy Combined With Ketamine in Difficult-to-Treat Depression.
Major Depressive Disorder (MDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott L Rauch, MD principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet Cognitive Behavioral Therapy in people with Major Depressive Disorder, run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Pre-treatment to Post-treatment (10 Weeks), Measured by the Hamilton Rating Scale for Depression, 17 Item Version (HRSD-17). (time frame: Measured at the baseline visit and 10 weeks after the baseline visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01598922, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2021.