Trial Outcomes & Findings for Internet Based Cognitive Behavioral Therapy Effects on Depressive Cognitions and Brain Function (NCT NCT01598922)

Last Updated: 2021-05-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

77 participants

Primary outcome timeframe

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

Results posted on

2021-05-25

Participant Flow

Healthy control subjects were not part of the clinical trial (they were not assigned to treatment).

Participant milestones

Participant milestones
Measure	Internet Cognitive Behavioral Therapy Participants with major depressive disorder who received a 10-week period of internet-based cognitive behavior therapy (iCBT): 6 online lessons and homework. They also received weekly check-in phone calls, and completed online depression rating scales.	Monitored Attention Control Participants with major depressive disorder who received no treatment. These participants logged into the online system the same number of times (6) to complete the same depression self-report scales as participants in the treatment group. They also received the same weekly check-in phone calls as the treatment group during the 10-week period. Participants in this arm were offered the iCBT treatment at the end of the study
Overall Study STARTED	37	40
Overall Study COMPLETED	34	30
Overall Study NOT COMPLETED	3	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Internet Cognitive Behavioral Therapy n=37 Participants Participants with major depressive disorder who received a 10-week period of internet-based cognitive behavior therapy (iCBT): 6 online lessons and homework. They also received weekly check-in phone calls, and completed online depression rating scales.	Monitored Attention Control n=40 Participants Participants with major depressive disorder who received no treatment. These participants logged into the online system the same number of times (6) to complete the same depression self-report scales as participants in the treatment group. They also received the same weekly check-in phone calls as the treatment group during the 10-week period. Participants in this arm were offered the iCBT treatment at the end of the study	Total n=77 Participants Total of all reporting groups
Age, Continuous	29.2 years STANDARD_DEVIATION 7.7 • n=5 Participants	28.8 years STANDARD_DEVIATION 6.7 • n=7 Participants	29.0 years STANDARD_DEVIATION 7.2 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	30 Participants n=7 Participants	53 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	10 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	25 Participants n=7 Participants	48 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Marital status, married	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Education	15.4 Years STANDARD_DEVIATION 2.5 • n=5 Participants	15.3 Years STANDARD_DEVIATION 2.0 • n=7 Participants	15.4 Years STANDARD_DEVIATION 2.3 • n=5 Participants
Employed outside the home	28 Participants n=5 Participants	24 Participants n=7 Participants	52 Participants n=5 Participants
Hamilton Rating Scale for Depression, 17 items	15.7 units on a scale STANDARD_DEVIATION 4.0 • n=5 Participants	15.7 units on a scale STANDARD_DEVIATION 4.3 • n=7 Participants	15.7 units on a scale STANDARD_DEVIATION 4.2 • n=5 Participants
Patient Health Questionnaire, 9 items	13.9 units on a scale STANDARD_DEVIATION 3.9 • n=5 Participants	15.6 units on a scale STANDARD_DEVIATION 4.0 • n=7 Participants	14.8 units on a scale STANDARD_DEVIATION 4.0 • n=5 Participants
Kessler Distress, 10 items	28.9 units on a scale STANDARD_DEVIATION 5.4 • n=5 Participants	30.8 units on a scale STANDARD_DEVIATION 4.5 • n=7 Participants	29.9 units on a scale STANDARD_DEVIATION 5.0 • n=5 Participants

PRIMARY outcome

Timeframe: Measured at the baseline visit and 10 weeks after the baseline visit

Population: Note that these are sample sizes.

Outcome measures

Outcome measures
Measure	Internet Cognitive Behavioral Therapy n=37 Participants Participants with major depressive disorder who received a 10-week period of internet-based cognitive behavior therapy (iCBT): 6 online lessons and homework. They also received weekly check-in phone calls, and completed online depression rating scales.	Monitored Attention Control n=40 Participants Participants with major depressive disorder who received no treatment. These participants logged into the online system the same number of times (6) to complete the same depression self-report scales as participants in the treatment group. They also received the same weekly check-in phone calls as the treatment group during the 10-week period. Participants in this arm were offered the iCBT treatment at the end of the study
Change From Pre-treatment to Post-treatment (10 Weeks), Measured by the Hamilton Rating Scale for Depression, 17 Item Version (HRSD-17). Pre-treatment HRSD-17	15.73 score on a scale Standard Deviation 4.02	15.70 score on a scale Standard Deviation 4.26
Change From Pre-treatment to Post-treatment (10 Weeks), Measured by the Hamilton Rating Scale for Depression, 17 Item Version (HRSD-17). Post-treatment HRSD-17	9.17 score on a scale Standard Deviation 6.92	14.05 score on a scale Standard Deviation 5.34

SECONDARY outcome

Timeframe: Baseline visit, and 10 weeks after baseline visit

Participants' scores on the PHQ-9 will be measured at baseline before treatment, each week during the treatment, and again at 10 weeks post-treatment. The range of possible scores on the PHQ-9 is 0 to 27 and higher scores indicate worse outcome or more severe depression

Outcome measures

Outcome measures
Measure	Internet Cognitive Behavioral Therapy n=37 Participants Participants with major depressive disorder who received a 10-week period of internet-based cognitive behavior therapy (iCBT): 6 online lessons and homework. They also received weekly check-in phone calls, and completed online depression rating scales.	Monitored Attention Control n=40 Participants Participants with major depressive disorder who received no treatment. These participants logged into the online system the same number of times (6) to complete the same depression self-report scales as participants in the treatment group. They also received the same weekly check-in phone calls as the treatment group during the 10-week period. Participants in this arm were offered the iCBT treatment at the end of the study
Weekly Patient Health Questionnaire (PHQ-9) Score	9.17 score on a scale Standard Deviation 6.92	14.05 score on a scale Standard Deviation 5.34

SECONDARY outcome

Timeframe: Week 10 score

The K-10 is a 10-item self-report measure of psychological distress. Items are scored on a scale from 1" ("none of the time") to "5" ("all of the time"). Total K-10 scores range from 10 to 50, with higher scores reflecting worse outcome or higher distress.

Outcome measures

Outcome measures
Measure	Internet Cognitive Behavioral Therapy n=37 Participants Participants with major depressive disorder who received a 10-week period of internet-based cognitive behavior therapy (iCBT): 6 online lessons and homework. They also received weekly check-in phone calls, and completed online depression rating scales.	Monitored Attention Control n=40 Participants Participants with major depressive disorder who received no treatment. These participants logged into the online system the same number of times (6) to complete the same depression self-report scales as participants in the treatment group. They also received the same weekly check-in phone calls as the treatment group during the 10-week period. Participants in this arm were offered the iCBT treatment at the end of the study
Weekly Kessler Psychological Distress Scale (K-10) Score	20.14 units on a scale Standard Deviation 7.37	26.73 units on a scale Standard Deviation 6.55

SECONDARY outcome

Timeframe: baseline, 10 weeks

Population: Analysis still ongoing, anticipated until January 2022

At 10 weeks (post-treatment), we will look for improvement from baseline in key brain regions known to be affected by depression. Differences in EIT and MID task-related brain responses will be measured.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline visit and 10 weeks after baseline visit

Population: Data not analyzed due to funding ending for this study

Participants' scores on the PANAS will be measured at baseline before treatment, and again at 10 weeks post-treatment. Two scores can be derived. 1) A positive affect score can range from 10 to 50, with higher scores representing better outcome or higher levels of positive affect; 2) Negative Affect score can range from 10 to 50, with higher scores representing better outcome or lower levels of negative affect.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline visit, and 10 weeks after baseline visit

Population: Data not analyzed due to funding ending for this study.

Participants' scores on the CD-RISC will be measured at baseline before treatment, and again at 10 weeks post-treatment. Total scores range from 0 to 100, with higher scores indicating a better outcome or higher resilience

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline visit and 10 weeks after baseline visit.

Population: Data still being analyzed and not analysis/paper not anticipated to be completed until January 2022

Participants' scores on the Modified Erikson Flanker Test will be measured at baseline before treatment, and again at 10 weeks post-treatment. Accuracy scores range from 0 to 1 with higher scores reflecting better outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline visit, 10 weeks after baseline visit.

Population: Data not analyzed due to funding ending.

Participants' scores on the IAT will be measured at baseline before treatment, and again at 10 weeks post-treatment. The IAT effect is called the D score with a possible range of -2 to +2, with larger scores reflecting worse outcome and stronger suicidality

Outcome measures

Outcome data not reported

Adverse Events

Internet Cognitive Behavioral Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Monitored Attention Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr.Isabelle Rosso

McLean Hospital

Phone: 6178552607

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place