Internet Based Cognitive Behavioral Therapy Effects on Depressive Cognitions and Brain Function

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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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

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Internet Cognitive Behavioral Therapy

Participants with major depressive disorder receive an 8-week long internet-based cognitive behavioral therapy program.

Group Type EXPERIMENTAL

Internet Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

8 weeks of online treatment program

Monitored Attention Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Internet Cognitive Behavioral Therapy

8 weeks of online treatment program

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No