Trial Outcomes & Findings for Spirituality Teaching Program for Depressed Adults (NCT NCT00322777)
NCT ID: NCT00322777
Last Updated: 2016-03-03
Results Overview
Depression severity was assessed at the four time points (baseline, 8 weeks, 16 weeks and 24 weeks) using the Hamilton Depression Rating Scale (HAM-D). The HAM-D is a standardized outcome measure of depression severity in adults. 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. The HAM-D was administered through a face to face interview, which was conducted by a trained nurse who was blinded to participants' allocation.
COMPLETED
NA
84 participants
baseline, 8 weeks, 16 weeks, and 24 weeks
2016-03-03
Participant Flow
Participant milestones
| Measure |
Spirituality Group
Arm where participants began the intervention (the Spirituality Teaching Program) upon recruitment for an 8 week period. Therefore, the program was initiated at week 1 of the trial.
|
Waitlist Control Group
Arm where participants began the intervention (the Spirituality Teaching Program) after an 8 week wait period. Therefore, the program was initiated at week 8 of the trial. Between week 1 and week 8, participants were instructed to carry out their day to day activities as before.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
45
|
|
Overall Study
Data Collection at BASELINE|
|
39
|
45
|
|
Overall Study
Data Collection at Week 8
|
39
|
45
|
|
Overall Study
Data Collection at Week 16
|
39
|
45
|
|
Overall Study
Data Collection at Week 24
|
39
|
45
|
|
Overall Study
COMPLETED
|
39
|
45
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Spirituality Teaching Program for Depressed Adults
Baseline characteristics by cohort
| Measure |
Spirituality Group
n=39 Participants
Arm where participants began the intervention (the Spirituality Teaching Program) upon recruitment for an 8 week period. Therefore, the program was initiated at week 1 of the trial.
|
Waitlist Control Group
n=45 Participants
Arm where participants began the intervention (the Spirituality Teaching Program) after an 8 week wait period. Therefore, the program was initiated at week 8 of the trial. Between week 1 and week 8, participants were instructed to carry out their day to day activities as before.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.1 years
STANDARD_DEVIATION 10.86 • n=5 Participants
|
44.0 years
STANDARD_DEVIATION 9.14 • n=7 Participants
|
44.02 years
STANDARD_DEVIATION 9.92 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Marital Status
Married/common law
|
27 participants
n=5 Participants
|
22 participants
n=7 Participants
|
49 participants
n=5 Participants
|
|
Marital Status
Not married
|
12 participants
n=5 Participants
|
23 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Education
less than or equal to Highschool
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Education
Some college or university
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Education
graduated from college or university
|
22 participants
n=5 Participants
|
24 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Education
Postgraduate or professional degree
|
2 participants
n=5 Participants
|
6 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Education
Not available
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Employment status
Paid work
|
31 participants
n=5 Participants
|
33 participants
n=7 Participants
|
64 participants
n=5 Participants
|
|
Employment status
No paid work
|
8 participants
n=5 Participants
|
12 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Religious denomination
No religion
|
14 participants
n=5 Participants
|
16 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Religious denomination
Christian
|
22 participants
n=5 Participants
|
25 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Religious denomination
Other
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Interest in spirituality
A little interested
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Interest in spirituality
Quite interested
|
11 participants
n=5 Participants
|
12 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Interest in spirituality
Very interested
|
24 participants
n=5 Participants
|
30 participants
n=7 Participants
|
54 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 8 weeks, 16 weeks, and 24 weeksDepression severity was assessed at the four time points (baseline, 8 weeks, 16 weeks and 24 weeks) using the Hamilton Depression Rating Scale (HAM-D). The HAM-D is a standardized outcome measure of depression severity in adults. 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. The HAM-D was administered through a face to face interview, which was conducted by a trained nurse who was blinded to participants' allocation.
Outcome measures
| Measure |
Spirituality Group
n=39 Participants
Arm where participants began the intervention (the Spirituality Teaching Program) upon recruitment for an 8 week period. Therefore, the program was initiated at week 1 of the trial.
|
Waitlist Control Group
n=45 Participants
Arm where participants began the intervention (the Spirituality Teaching Program) after an 8 week wait period. Therefore, the program was initiated at week 8 of the trial. Between week 1 and week 8, participants were instructed to carry out their day to day activities as before.
|
|---|---|---|
|
Hamilton Depression Rating Scale - Depression Severity
8 weeks
|
11.9 units on a scale
Interval 10.2 to 13.5
|
18.0 units on a scale
Interval 16.4 to 19.7
|
|
Hamilton Depression Rating Scale - Depression Severity
16 weeks
|
10.7 units on a scale
Interval 8.5 to 13.0
|
12.0 units on a scale
Interval 9.8 to 14.2
|
|
Hamilton Depression Rating Scale - Depression Severity
24 weeks
|
10.4 units on a scale
Interval 8.0 to 12.7
|
10.1 units on a scale
Interval 7.8 to 12.4
|
|
Hamilton Depression Rating Scale - Depression Severity
Baseline
|
20.4 units on a scale
Interval 19.9 to 20.9
|
20.3 units on a scale
Interval 19.8 to 20.8
|
SECONDARY outcome
Timeframe: baseline, 8 weeks, 16 weeks, and 24 weeksResponse rate was assessed at the four time points (baseline, 8 weeks, 16 weeks and 24 weeks) using the Hamilton Depression Rating Scale (HAM-D). A response was determined as a reduction in the HAM-D score by at least 50% from the baseline score. The data are presented as the percentage of participants with response at each time point as compared to baseline.
Outcome measures
| Measure |
Spirituality Group
n=39 Participants
Arm where participants began the intervention (the Spirituality Teaching Program) upon recruitment for an 8 week period. Therefore, the program was initiated at week 1 of the trial.
|
Waitlist Control Group
n=45 Participants
Arm where participants began the intervention (the Spirituality Teaching Program) after an 8 week wait period. Therefore, the program was initiated at week 8 of the trial. Between week 1 and week 8, participants were instructed to carry out their day to day activities as before.
|
|---|---|---|
|
Response Rate
8 weeks
|
35.9 percentage of participants with response
|
4.4 percentage of participants with response
|
|
Response Rate
16 weeks
|
56.4 percentage of participants with response
|
51.1 percentage of participants with response
|
|
Response Rate
24 weeks
|
64.1 percentage of participants with response
|
66.7 percentage of participants with response
|
SECONDARY outcome
Timeframe: baseline, 8 weeks, 16 weeks, and 24 weeksRemission of depression was assessed at the four time points (baseline, 8 weeks, 16 weeks and 24 weeks) using the Hamilton Depression Rating Scale (HAM-D). Remission was based on a HAM-D score of less than 7. Remission is indicated as a percentage of participants at each time point whose scores were below 7.
Outcome measures
| Measure |
Spirituality Group
n=39 Participants
Arm where participants began the intervention (the Spirituality Teaching Program) upon recruitment for an 8 week period. Therefore, the program was initiated at week 1 of the trial.
|
Waitlist Control Group
n=45 Participants
Arm where participants began the intervention (the Spirituality Teaching Program) after an 8 week wait period. Therefore, the program was initiated at week 8 of the trial. Between week 1 and week 8, participants were instructed to carry out their day to day activities as before.
|
|---|---|---|
|
Remission
8 weeks
|
30.7 percentage of participants score < 7
|
2.2 percentage of participants score < 7
|
|
Remission
16 weeks
|
38.5 percentage of participants score < 7
|
31.1 percentage of participants score < 7
|
|
Remission
24 weeks
|
41 percentage of participants score < 7
|
53.3 percentage of participants score < 7
|
Adverse Events
Spirituality Group
Waitlist Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Badri Rickhi
Canadian Institute of Natural and Integrative Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place