Trial Outcomes & Findings for Internet-delivered Psychotherapy for Depression (NCT NCT02091856)
NCT ID: NCT02091856
Last Updated: 2018-06-28
Results Overview
The Beck Depression Inventory-II (BDI-II) was designed to measure participant's level of depression. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression. This represents the post-intervention assessment.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
79 participants
Primary outcome timeframe
Absolute values (average score) of Back Depression Inventory-II at 11 weeks (post-intervention)
Results posted on
2018-06-28
Participant Flow
Participant milestones
| Measure |
Conventional-CBT (C-CBT)
This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.
Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm.
|
Religious CBT (R-CBT)
This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.
Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief.
|
Wait List Control Group (WLCG)
This arm represents the wait-list comparison group.
|
|---|---|---|---|
|
Active Intervention Interval
STARTED
|
34
|
19
|
26
|
|
Active Intervention Interval
COMPLETED
|
15
|
12
|
19
|
|
Active Intervention Interval
NOT COMPLETED
|
19
|
7
|
7
|
|
Follow-up Assessment
STARTED
|
15
|
12
|
0
|
|
Follow-up Assessment
COMPLETED
|
10
|
9
|
0
|
|
Follow-up Assessment
NOT COMPLETED
|
5
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Internet-delivered Psychotherapy for Depression
Baseline characteristics by cohort
| Measure |
Conventional-CBT (C-CBT)
n=34 Participants
This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.
Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Positive CBT intervention includes set of exercises devised from the positive psychology paradigm. Similarly, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief.
|
Religious CBT (R-CBT)
n=19 Participants
This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.
Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Positive CBT intervention includes set of exercises devised from the positive psychology paradigm. Similarly, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief.
|
Wait List Control Group (WLCG)
n=26 Participants
This arm represents the wait-list comparison group.
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
29.21 years
STANDARD_DEVIATION 8.88 • n=5 Participants
|
32.21 years
STANDARD_DEVIATION 11.66 • n=7 Participants
|
35.65 years
STANDARD_DEVIATION 9.15 • n=5 Participants
|
32.05 years
STANDARD_DEVIATION 9.97 • n=4 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Region of Enrollment
Romania
|
34 participants
n=5 Participants
|
19 participants
n=7 Participants
|
26 participants
n=5 Participants
|
79 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Absolute values (average score) of Back Depression Inventory-II at 11 weeks (post-intervention)The Beck Depression Inventory-II (BDI-II) was designed to measure participant's level of depression. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression. This represents the post-intervention assessment.
Outcome measures
| Measure |
Conventional-CBT (C-CBT)
n=34 Participants
This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.
Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm.
|
Religious CBT (R-CBT)
n=19 Participants
This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.
Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief.
|
Wait List Control Group (WLCG)
n=26 Participants
This arm represents the wait-list comparison group.
|
|---|---|---|---|
|
Beck Depression Inventory-II (BDI-II)
|
11.45 units on a scale
Standard Deviation 10.46
|
12.43 units on a scale
Standard Deviation 15.04
|
26.02 units on a scale
Standard Deviation 8.74
|
PRIMARY outcome
Timeframe: Absolute values (average score) of BDI-II at 37 weeks (follow-up)Population: Only 10 participants from the C-CBT and 9 participants from the R-CBT completed the follow-up assessment questionnaires. Participants from the Wailt-List Control Group were lost at follow-up.
The Beck Depression Inventory-II (BDI-II) was designed to measure participant's level of depression. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression. This represents the measure of depression at 6 month after the intervention.
Outcome measures
| Measure |
Conventional-CBT (C-CBT)
n=10 Participants
This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.
Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm.
|
Religious CBT (R-CBT)
n=9 Participants
This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.
Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief.
|
Wait List Control Group (WLCG)
This arm represents the wait-list comparison group.
|
|---|---|---|---|
|
Beck Depression Inventory II (BDI-II)
|
15.20 units on a scale
Standard Deviation 13.11
|
13.56 units on a scale
Standard Deviation 12.49
|
—
|
SECONDARY outcome
Timeframe: Absolute values (average score) of Back Anxiety Inventory at 11 weeks (post-intervention)The Beck Anxiety Inventory (BAI) was designed to measure participant's level of anxiety. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of anxiety, while high scores are associated with high levels of anxiety. This represent the post-intervention assessment.
Outcome measures
| Measure |
Conventional-CBT (C-CBT)
n=34 Participants
This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.
Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm.
|
Religious CBT (R-CBT)
n=19 Participants
This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.
Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief.
|
Wait List Control Group (WLCG)
n=26 Participants
This arm represents the wait-list comparison group.
|
|---|---|---|---|
|
Beck Anxiety Inventory (BAI)
|
24.72 units on a scale
Standard Deviation 13.60
|
22.62 units on a scale
Standard Deviation 13.90
|
27.27 units on a scale
Standard Deviation 12.33
|
SECONDARY outcome
Timeframe: Absolute values (average score) of QOLI at 11 weeks (post-intervention)The Quality of Life Inventory (QOLI) is an established rating scale of self-perceived quality of life across 16 domains. The scale is unidimensional and the total score rages from -6 to +6. Low scores are associated with low self-perceived life quality, while high scores are associated with high self-perceived life quality. This represents the post-intervention assessment.
Outcome measures
| Measure |
Conventional-CBT (C-CBT)
n=34 Participants
This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.
Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm.
|
Religious CBT (R-CBT)
n=19 Participants
This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.
Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief.
|
Wait List Control Group (WLCG)
n=26 Participants
This arm represents the wait-list comparison group.
|
|---|---|---|---|
|
Quality of Life Inventory (QOLI)
|
.74 units on a scale
Standard Deviation 2.03
|
.39 units on a scale
Standard Deviation 1.62
|
-.92 units on a scale
Standard Deviation 1.79
|
SECONDARY outcome
Timeframe: Absolute values (average score) of QIDS-SR after 11 weeks (post-treatment)The Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) was designed to measure participant's level of depression. The scale is unidimensional and the total score rages from 0 to 27. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression. This represents a secondary outcome measure for depression taken immediately after the intervention.
Outcome measures
| Measure |
Conventional-CBT (C-CBT)
n=34 Participants
This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.
Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm.
|
Religious CBT (R-CBT)
n=19 Participants
This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.
Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief.
|
Wait List Control Group (WLCG)
n=26 Participants
This arm represents the wait-list comparison group.
|
|---|---|---|---|
|
Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
|
10.47 units on a scale
Standard Deviation 5.69
|
10.27 units on a scale
Standard Deviation 6.17
|
14.90 units on a scale
Standard Deviation 4.24
|
Adverse Events
Conventional-CBT (C-CBT)
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Religious CBT (R-CBT)
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Wait List Control Group (WLCG)
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Conventional-CBT (C-CBT)
n=34 participants at risk
This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.
Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm.
|
Religious CBT (R-CBT)
n=19 participants at risk
This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.
Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief.
|
Wait List Control Group (WLCG)
n=26 participants at risk
This arm represents the wait-list comparison group.
|
|---|---|---|---|
|
Psychiatric disorders
Major depression disorder (MDD) or dysthymia
|
100.0%
34/34 • Number of events 34 • Other Adverse Events (depression levels) were collected weekly through study completion (an average of 11 weeks).
Because assessment data were collected online Serious Adverse Events were not assessed as part of the study. Considering the inclusion criteria PI inferred that major depression or dysthymia represents Other Adverse Events that occurred in all participants.
|
100.0%
19/19 • Number of events 19 • Other Adverse Events (depression levels) were collected weekly through study completion (an average of 11 weeks).
Because assessment data were collected online Serious Adverse Events were not assessed as part of the study. Considering the inclusion criteria PI inferred that major depression or dysthymia represents Other Adverse Events that occurred in all participants.
|
100.0%
26/26 • Number of events 26 • Other Adverse Events (depression levels) were collected weekly through study completion (an average of 11 weeks).
Because assessment data were collected online Serious Adverse Events were not assessed as part of the study. Considering the inclusion criteria PI inferred that major depression or dysthymia represents Other Adverse Events that occurred in all participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place