N/A
Completed N=77
Internet Based Cognitive Behavioral Therapy Effects on Depressive Cognitions and Brain Function
Source: ClinicalTrials.gov NCT01598922 ↗Enrolled (actual)
77
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcomePrimary: Change From Pre-treatment to Post-treatment (10 Weeks), Measured by the Hamilton Rating Scale for Depression, 17 Item Version (HRSD-17). — 15.73; 15.70; 9.17; 14.05 score on a scale — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Pre-treatment to Post-treatment (10 Weeks), Measured by the Hamilton Rating Scale for Depression, 17 Item Version (HRSD-17). |
15.73; 15.70; 9.17; 14.05 | <0.0001 sig |
| SECONDARY Weekly Patient Health Questionnaire (PHQ-9) Score |
9.17; 14.05 | .024 sig |
| SECONDARY Weekly Kessler Psychological Distress Scale (K-10) Score |
20.14; 26.73 | .003 sig |
| SECONDARY Improvement From Baseline in Brain Functioning on the Emotional Interference Task (EIT) and the Monetary Incentive Delay Task (MID) |
— | — |
| SECONDARY Change From Baseline in Positive and Negative Affect Scale (PANAS) Score |
— | — |
| SECONDARY Change From Baseline in Connor Davidson Resilience Scale (CD-RISC) Score |
— | — |
| SECONDARY Change From Baseline in Modified Erikson Flanker Test |
— | — |
| SECONDARY Change From Baseline in Implicit Association Test (IAT) |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT01598922). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.