Trial Outcomes & Findings for E-Mental Health Adolescent Depression Program (LEAP) (NCT NCT00985686)
NCT ID: NCT00985686
Last Updated: 2015-07-29
Results Overview
Measure of depression severity in individuals 13 to 18 years of age. CDRS-R total raw scores includes the sum of 17 items, each item's scoring range is from 1 (no difficulties) to 5 (severe clinically significant difficulties) or 1 (no difficulties) to 7 (severe clinically significant difficulties), with a total possible raw score ranging from 17 to 113. To meet eligibility requirements, participants required a total raw score of 40 to 70.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
63 participants
Primary outcome timeframe
At 8 week intervals over a 24 week period
Results posted on
2015-07-29
Participant Flow
Participant milestones
| Measure |
Study Arm, Younger Subgroup
Arm where younger participants (13 to 18 years of age) began the LEAP Project intervention upon recruitment for an 8 week period.
LEAP Project: In collaboration with experts from Alberta Health Services, the University of Calgary, and Mount Royal University, the Canadian Institute of Natural and Integrative Medicine (CINIM) has created the LEAP Project, a spirituality informed e-mental health intervention, for young people with major depressive disorders (see Appendix for sample materials). It is an online, eight module, multimedia intervention delivered over eight weeks, requiring a weekly commitment of 2-3 hours. The intervention is non-denominational and avoids a focus on any religious traditions. The program aims to treat depression by guiding depressed young people through an exploration of spiritual concepts and principles.
|
Study Arm, Older Subgroup
Arm where older participants (19 to 24 years of age) began the LEAP Project intervention upon recruitment for an 8 week period.
LEAP Project: In collaboration with experts from Alberta Health Services, the University of Calgary, and Mount Royal University, the Canadian Institute of Natural and Integrative Medicine (CINIM) has created the LEAP Project, a spirituality informed e-mental health intervention, for young people with major depressive disorders (see Appendix for sample materials). It is an online, eight module, multimedia intervention delivered over eight weeks, requiring a weekly commitment of 2-3 hours. The intervention is non-denominational and avoids a focus on any religious traditions. The program aims to treat depression by guiding depressed young people through an exploration of spiritual concepts and principles.
|
Waitlist Arm, Younger Subgroup
Arm where younger participants (13-18 years of age) received the LEAP Project intervention after an 8 week wait period.
At 8 weeks, the results from the wait-list arm (no intervention) were compared to the results of the study arm (intervention completed).
LEAP Project: In collaboration with experts from Alberta Health Services, the University of Calgary, and Mount Royal University, the Canadian Institute of Natural and Integrative Medicine (CINIM) has created the LEAP Project, a spirituality informed e-mental health intervention, for young people with major depressive disorders (see Appendix for sample materials). It is an online, eight module, multimedia intervention delivered over eight weeks, requiring a weekly commitment of 2-3 hours. The intervention is non-denominational and avoids a focus on any religious traditions. The program aims to treat depression by guiding depressed young people through an exploration of spiritual concepts and principles.
|
Waitlist Arm, Older Subgroup
Arm where older participants (19 to 24 years of age) received the LEAP Project intervention after an 8 week wait period.
At 8 weeks, the results from the wait-list arm (no intervention) were compared to the results of the study arm (intervention completed).
LEAP Project: In collaboration with experts from Alberta Health Services, the University of Calgary, and Mount Royal University, the Canadian Institute of Natural and Integrative Medicine (CINIM) has created the LEAP Project, a spirituality informed e-mental health intervention, for young people with major depressive disorders (see Appendix for sample materials). It is an online, eight module, multimedia intervention delivered over eight weeks, requiring a weekly commitment of 2-3 hours. The intervention is non-denominational and avoids a focus on any religious traditions. The program aims to treat depression by guiding depressed young people through an exploration of spiritual concepts and principles.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
16
|
13
|
16
|
|
Overall Study
Visit 1: Baseline Data Collection
|
18
|
15
|
13
|
16
|
|
Overall Study
Visit 2: Data Collection at 8 Weeks
|
18
|
15
|
13
|
16
|
|
Overall Study
Visit 3: Data Collection at 16 Weeks
|
17
|
15
|
13
|
16
|
|
Overall Study
Visit 4: Data Collection at 24 Weeks
|
17
|
15
|
13
|
14
|
|
Overall Study
COMPLETED
|
17
|
15
|
13
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
2
|
Reasons for withdrawal
| Measure |
Study Arm, Younger Subgroup
Arm where younger participants (13 to 18 years of age) began the LEAP Project intervention upon recruitment for an 8 week period.
LEAP Project: In collaboration with experts from Alberta Health Services, the University of Calgary, and Mount Royal University, the Canadian Institute of Natural and Integrative Medicine (CINIM) has created the LEAP Project, a spirituality informed e-mental health intervention, for young people with major depressive disorders (see Appendix for sample materials). It is an online, eight module, multimedia intervention delivered over eight weeks, requiring a weekly commitment of 2-3 hours. The intervention is non-denominational and avoids a focus on any religious traditions. The program aims to treat depression by guiding depressed young people through an exploration of spiritual concepts and principles.
|
Study Arm, Older Subgroup
Arm where older participants (19 to 24 years of age) began the LEAP Project intervention upon recruitment for an 8 week period.
LEAP Project: In collaboration with experts from Alberta Health Services, the University of Calgary, and Mount Royal University, the Canadian Institute of Natural and Integrative Medicine (CINIM) has created the LEAP Project, a spirituality informed e-mental health intervention, for young people with major depressive disorders (see Appendix for sample materials). It is an online, eight module, multimedia intervention delivered over eight weeks, requiring a weekly commitment of 2-3 hours. The intervention is non-denominational and avoids a focus on any religious traditions. The program aims to treat depression by guiding depressed young people through an exploration of spiritual concepts and principles.
|
Waitlist Arm, Younger Subgroup
Arm where younger participants (13-18 years of age) received the LEAP Project intervention after an 8 week wait period.
At 8 weeks, the results from the wait-list arm (no intervention) were compared to the results of the study arm (intervention completed).
LEAP Project: In collaboration with experts from Alberta Health Services, the University of Calgary, and Mount Royal University, the Canadian Institute of Natural and Integrative Medicine (CINIM) has created the LEAP Project, a spirituality informed e-mental health intervention, for young people with major depressive disorders (see Appendix for sample materials). It is an online, eight module, multimedia intervention delivered over eight weeks, requiring a weekly commitment of 2-3 hours. The intervention is non-denominational and avoids a focus on any religious traditions. The program aims to treat depression by guiding depressed young people through an exploration of spiritual concepts and principles.
|
Waitlist Arm, Older Subgroup
Arm where older participants (19 to 24 years of age) received the LEAP Project intervention after an 8 week wait period.
At 8 weeks, the results from the wait-list arm (no intervention) were compared to the results of the study arm (intervention completed).
LEAP Project: In collaboration with experts from Alberta Health Services, the University of Calgary, and Mount Royal University, the Canadian Institute of Natural and Integrative Medicine (CINIM) has created the LEAP Project, a spirituality informed e-mental health intervention, for young people with major depressive disorders (see Appendix for sample materials). It is an online, eight module, multimedia intervention delivered over eight weeks, requiring a weekly commitment of 2-3 hours. The intervention is non-denominational and avoids a focus on any religious traditions. The program aims to treat depression by guiding depressed young people through an exploration of spiritual concepts and principles.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
2
|
Baseline Characteristics
E-Mental Health Adolescent Depression Program (LEAP)
Baseline characteristics by cohort
| Measure |
Study Arm, Younger Subgroup
n=18 Participants
Subgroup of participants 13-18 years of age randomized into the study arm.
|
Study Arm, Older Subgroup
n=15 Participants
Subgroup of participants 19-24 years of age randomized into the study arm.
|
Waitlist Arm, Younger Subgroup
n=13 Participants
Subgroup of participants 13-18 years of age randomized into the waitlist arm.
|
Waitlist Arm, Older Subgroup
n=16 Participants
Subgroup of participants 19-24 years of age randomized into the waitlist arm.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
15.3 years
n=5 Participants
|
21.0 years
n=7 Participants
|
15.2 years
n=5 Participants
|
20.9 years
n=4 Participants
|
18.1 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Region of Enrollment
Canada
|
18 participants
n=5 Participants
|
15 participants
n=7 Participants
|
13 participants
n=5 Participants
|
16 participants
n=4 Participants
|
62 participants
n=21 Participants
|
|
Use of other treatments during intervention phase
Anti-depressants only
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
10 participants
n=21 Participants
|
|
Use of other treatments during intervention phase
Counselling only
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
3 participants
n=5 Participants
|
4 participants
n=4 Participants
|
16 participants
n=21 Participants
|
|
Use of other treatments during intervention phase
Anti-depressants and Counselling
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Use of other treatments during intervention phase
None
|
11 participants
n=5 Participants
|
6 participants
n=7 Participants
|
7 participants
n=5 Participants
|
10 participants
n=4 Participants
|
34 participants
n=21 Participants
|
|
Education
High School
|
15 participants
n=5 Participants
|
0 participants
n=7 Participants
|
13 participants
n=5 Participants
|
0 participants
n=4 Participants
|
28 participants
n=21 Participants
|
|
Education
Post Secondary Institution
|
1 participants
n=5 Participants
|
10 participants
n=7 Participants
|
0 participants
n=5 Participants
|
14 participants
n=4 Participants
|
25 participants
n=21 Participants
|
|
Education
Not in School
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
9 participants
n=21 Participants
|
|
Religions denomination indicated
Yes
|
11 participants
n=5 Participants
|
6 participants
n=7 Participants
|
5 participants
n=5 Participants
|
8 participants
n=4 Participants
|
30 participants
n=21 Participants
|
|
Religions denomination indicated
No
|
7 participants
n=5 Participants
|
9 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
32 participants
n=21 Participants
|
|
Work situation
Working
|
5 participants
n=5 Participants
|
8 participants
n=7 Participants
|
3 participants
n=5 Participants
|
10 participants
n=4 Participants
|
26 participants
n=21 Participants
|
|
Work situation
Not Working
|
13 participants
n=5 Participants
|
7 participants
n=7 Participants
|
10 participants
n=5 Participants
|
6 participants
n=4 Participants
|
36 participants
n=21 Participants
|
|
Living situation
With both parents
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
10 participants
n=4 Participants
|
33 participants
n=21 Participants
|
|
Living situation
One parent
|
8 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
17 participants
n=21 Participants
|
|
Living situation
Partner
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Living situation
Roommate
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Living situation
Alone
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Living situation
Other
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
7 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: At 8 week intervals over a 24 week periodMeasure of depression severity in individuals 13 to 18 years of age. CDRS-R total raw scores includes the sum of 17 items, each item's scoring range is from 1 (no difficulties) to 5 (severe clinically significant difficulties) or 1 (no difficulties) to 7 (severe clinically significant difficulties), with a total possible raw score ranging from 17 to 113. To meet eligibility requirements, participants required a total raw score of 40 to 70.
Outcome measures
| Measure |
Younger Subgroup (13-18 Years of Age)
n=31 Participants
Subgroup of participants 13-18 years of age. Participants were randomized into the Study and Waitlist Arms.
|
|---|---|
|
Children's Depression Rating Scale Revised (CDRS-R)
Study Arm - Baseline (n=18)
|
57.18 units on a scale
Standard Error 1.87
|
|
Children's Depression Rating Scale Revised (CDRS-R)
Waitlist Arm - Baseline (n=13)
|
61.67 units on a scale
Standard Error 2.21
|
|
Children's Depression Rating Scale Revised (CDRS-R)
Study Arm - Week 8 (n=18)
|
44.94 units on a scale
Standard Error 2.86
|
|
Children's Depression Rating Scale Revised (CDRS-R)
Waitlist Arm - Week 8 (n=13)
|
58.93 units on a scale
Standard Error 3.37
|
|
Children's Depression Rating Scale Revised (CDRS-R)
Study Arm - Week 16 (n=18)
|
36.54 units on a scale
Standard Error 2.77
|
|
Children's Depression Rating Scale Revised (CDRS-R)
Waitlist Arm - Week 16 (n=13)
|
44.97 units on a scale
Standard Error 3.26
|
|
Children's Depression Rating Scale Revised (CDRS-R)
Study Arm - Week 24 (n=17)
|
34.37 units on a scale
Standard Error 3.22
|
|
Children's Depression Rating Scale Revised (CDRS-R)
Waitlist Arm - Week 24 (n=13)
|
42.28 units on a scale
Standard Error 3.79
|
PRIMARY outcome
Timeframe: At 8 week intervals over a 24 week periodMeasure of depression severity in individuals 19 to 24 years of age. HAMD total scores includes the sum of 17-items, with eight items scored on a range of 0 (absent) to 2 (marked or definite) and nine scored on a range of 0 (absent) to 4 (very severe). The level of depression was based on the following scoring ranges: 7 or under not depressed, 8-13 some depressive symptoms but no depressive disorder, 12-15 mild depression, 16-19 moderate depression, 20-24 moderately severe depression, and 25+ severe depression. To meet eligibility requirements, participants required a total score of 12-24.
Outcome measures
| Measure |
Younger Subgroup (13-18 Years of Age)
n=31 Participants
Subgroup of participants 13-18 years of age. Participants were randomized into the Study and Waitlist Arms.
|
|---|---|
|
Hamilton Depression Rating Scale (HAMD)
Waitlist Arm - Week 24 (n=14)
|
8.49 units on a scale
Standard Error 1.40
|
|
Hamilton Depression Rating Scale (HAMD)
Study Arm - Baseline (n=15)
|
22.14 units on a scale
Standard Error 0.65
|
|
Hamilton Depression Rating Scale (HAMD)
Waitlist Arm - Baseline (n=16)
|
20.90 units on a scale
Standard Error 0.65
|
|
Hamilton Depression Rating Scale (HAMD)
Study Arm - Week 8 (n=15)
|
14.07 units on a scale
Standard Error 1.13
|
|
Hamilton Depression Rating Scale (HAMD)
Waitlist Arm - Week 8 (n=16)
|
17.79 units on a scale
Standard Error 1.12
|
|
Hamilton Depression Rating Scale (HAMD)
Study Arm - Week 16 (n=15)
|
11.40 units on a scale
Standard Error 1.39
|
|
Hamilton Depression Rating Scale (HAMD)
Waitlist Arm - Week 16 (n=16)
|
9.91 units on a scale
Standard Error 1.39
|
|
Hamilton Depression Rating Scale (HAMD)
Study Arm - Week 24 (n=15)
|
8.81 units on a scale
Standard Error 1.4
|
SECONDARY outcome
Timeframe: At 8 week intervals over a 24 week periodMeasure of self-concept in 13 to 18 year olds. The scale can be completed in 10-15 minutes and includes 60 items covering six subscales: physical appearance and attributes, intellectual and school status, happiness and satisfaction, freedom from anxiety, behavioural adjustment and popularity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 8 week intervals over a 24 week periodMeasure of self concept in 19 to 24 year olds. The Six-Factor Self-Concept Scale is a multidimensional measure of adult self-concept that was designed to have broad applicability across life settings, roles, and activities. The scale consist of 115 items and assess six factors including likability, morality, task accomplishment, giftedness, power and vulnerability.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 8 week intervals over a 24 week periodMeasure of psychological well-being in 19 to 24 year olds. The POMS has the format of an adjective check list and consists of 65 items. It provides a total score of mood disturbance and six factor based subscale scores.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 8 week intervals over a 24 week periodMeasure of level spiritual well-being in 13-18 year olds. The self administered 10-item version was used.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 8 week intervals over a 24 week periodMeasure of spiritual well-being in 19 to 24 year olds. The instrument is self-administered and contains 26 items in a Likert-type format.
Outcome measures
Outcome data not reported
Adverse Events
Study Arm, Younger Subgroup
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Study Arm, Older Subgroup
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Waitlist Arm, Younger Subgroup
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Waitlist Arm, Older Subgroup
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. John Toews
Canadian Institute of Natural and Integrative Medicine
Phone: 4032200022
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place