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

NCT01598922 | Completed Results

• 1 other identifier: W81XWH-12-1-0109
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Depression; Internet Cognitive Behavioral Therapy; fMRI; Neuroimaging

Outcome Measures

Primary Outcomes (1)

• 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 at the baseline visit and 10 weeks after the baseline visit

Secondary Outcomes (7)

• Weekly Patient Health Questionnaire (PHQ-9) Score

  Baseline visit, and 10 weeks after baseline visit

• Weekly Kessler Psychological Distress Scale (K-10) Score

  Week 10 score

• Improvement From Baseline in Brain Functioning on the Emotional Interference Task (EIT) and the Monetary Incentive Delay Task (MID)

  baseline, 10 weeks

• Change From Baseline in Positive and Negative Affect Scale (PANAS) Score

  Baseline visit and 10 weeks after baseline visit

• Change From Baseline in Connor Davidson Resilience Scale (CD-RISC) Score

  Baseline visit, and 10 weeks after baseline visit

Study Arms (2)

Internet Cognitive Behavioral Therapy

EXPERIMENTAL

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

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.

Interventions

Internet Cognitive Behavioral Therapy BEHAVIORAL

8 weeks of online treatment program

Internet Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Mclean Hospital: lead

Study Sites (1)

Isabelle Rosso

Belmont, Massachusetts, 02478, United States

Location

Related Publications (5)

• 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.

  PMID: 20183695 BACKGROUND

• 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.

  PMID: 15229303 BACKGROUND

• 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.

  PMID: 20544030 BACKGROUND

• 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.

  PMID: 28009467 RESULT

• 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.

  PMID: 29486867 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr.Isabelle Rosso
• Organization: McLean Hospital

irosso@partners.org

6178552607

Study Officials

• Scott L Rauch, MD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President and Psychiatrist-in-Chief

Model Details: 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.

Study Record Dates

• First Submitted: May 11, 2012
• First Posted: May 15, 2012
• Study Start: October 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: May 25, 2021
• Results First Posted: December 7, 2020

Record last verified: 2021-05

Locations

US (1)