This trial is active, not recruiting.

Condition major depressive disorder
Treatment internet cognitive behavioral therapy
Sponsor Mclean Hospital
Start date October 2012
End date October 2015
Trial size 108 participants
Trial identifier NCT01598922, W81XWH-12-1-0109


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Participants with major depressive disorder receive an 8-week long internet-based cognitive behavioral therapy program.
internet cognitive behavioral therapy
8 weeks of online treatment program
(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.
(No Intervention)
Participants in this arm are healthy, non-psychiatric individuals who receive no treatment.

Primary Outcomes

Change from baseline in Hamilton Rating Scale for Depression (HAM-D) score
time frame: baseline and 10 weeks

Secondary Outcomes

Improvement from baseline in brain functioning on the Emotional Interference Task (EIT) and the Monetary Incentive Delay Task (MID)
time frame: baseline and 10 weeks
Weekly change in Patient Health Questionnaire (PHQ-9) score
time frame: Baseline, weeks 1 - 10, 10 weeks
Weekly change in Kessler Psychological Distress Scale (K-10) score
time frame: Baseline, weeks 1 - 10, 10 weeks
Change from baseline in Positive and Negative Affect Scale (PANAS) score
time frame: Baseline and 10 weeks
Change from baseline in Connor Davidson Resilience Scale (CD-RISC) score
time frame: Baseline and 10 weeks
Change from baseline in Modified Erikson Flanker Test
time frame: Baseline and 10 weeks
Change from baseline in Implicit Association Test (IAT)
time frame: Baseline and 10 weeks

Eligibility Criteria

Male or female participants from 18 years up to 45 years old.

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

Additional Information

Official title Internet Based Cognitive Behavioral Therapy Effects on Depressive Cognitions and Brain Function
Principal investigator Scott L Rauch, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Mclean Hospital.