Clinical trial NCT01598922: Internet Based Cognitive Behavioral Therapy Effects on Depressive Cognitions and Brain Function
Official title: Internet Based Cognitive Behavioral Therapy Effects on Depressive Cognitions and Brain Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Depression
Internet Cognitive Behavioral Therapy
fMRI
Neuroimaging
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
First posted: 2012-05-15
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change From Pre-treatment to Post-treatment (10 Weeks), Measured by the Hamilton Rating Scale for Depression, 17 Item Version (HRSD-17).
timeFrame: Measured at the baseline visit and 10 weeks after the baseline visit
Secondary outcomes:
measure: Weekly Patient Health Questionnaire (PHQ-9) Score
timeFrame: Baseline visit, and 10 weeks after baseline visit
measure: Weekly Kessler Psychological Distress Scale (K-10) Score
timeFrame: Week 10 score
measure: Improvement From Baseline in Brain Functioning on the Emotional Interference Task (EIT) and the Monetary Incentive Delay Task (MID)
timeFrame: baseline, 10 weeks
measure: Change From Baseline in Positive and Negative Affect Scale (PANAS) Score
timeFrame: Baseline visit and 10 weeks after baseline visit
measure: Change From Baseline in Connor Davidson Resilience Scale (CD-RISC) Score
timeFrame: Baseline visit, and 10 weeks after baseline visit
measure: Change From Baseline in Modified Erikson Flanker Test
timeFrame: Baseline visit and 10 weeks after baseline visit.
measure: Change From Baseline in Implicit Association Test (IAT)
timeFrame: Baseline visit, 10 weeks after baseline visit.
Other outcomes:
Locations:
city: Belmont
country: United States
facility: Isabelle Rosso
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Scott L Rauch, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.