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Spirituality Teaching Program for Depressed Adults

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ClinicalTrials.gov Identifier: NCT00322777
Recruitment Status : Completed
First Posted : May 8, 2006
Results First Posted : March 3, 2016
Last Update Posted : March 3, 2016
Sponsor:
Collaborators:
University of Calgary, Dept. of Psychiatry & Dept. of Community Health Sciences
Southwest Behavioral Health Sciences
Alberta Health Services
Arizona School of Health Sciences
The Center for Mind-Body Medicine
Information provided by (Responsible Party):
Badri Rickhi, Canadian Institute of Natural and Integrative Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depression
Intervention Behavioral: Spirituality Teaching Program
Enrollment 84
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Spirituality Group Waitlist Control Group
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 39 45
Data Collection at BASELINE| 39 45
Data Collection at Week 8 39 45
Data Collection at Week 16 39 45
Data Collection at Week 24 39 45
Completed 39 45
Not Completed 0 0
Arm/Group Title Spirituality Group Waitlist Control Group Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 39 45 84
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 45 participants 84 participants
44.1  (10.86) 44.0  (9.14) 44.02  (9.92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 45 participants 84 participants
Female
29
  74.4%
36
  80.0%
65
  77.4%
Male
10
  25.6%
9
  20.0%
19
  22.6%
Marital Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 39 participants 45 participants 84 participants
Married/common law 27 22 49
Not married 12 23 35
Education  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 39 participants 45 participants 84 participants
less than or equal to Highschool 5 7 12
Some college or university 9 8 17
graduated from college or university 22 24 46
Postgraduate or professional degree 2 6 8
Not available 1 0 1
Employment status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 39 participants 45 participants 84 participants
Paid work 31 33 64
No paid work 8 12 20
Religious denomination  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 39 participants 45 participants 84 participants
No religion 14 16 30
Christian 22 25 47
Other 3 4 7
Interest in spirituality  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 39 participants 45 participants 84 participants
A little interested 4 3 7
Quite interested 11 12 23
Very interested 24 30 54
1.Primary Outcome
Title Hamilton Depression Rating Scale - Depression Severity
Hide Description

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.

Time Frame baseline, 8 weeks, 16 weeks, and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spirituality Group Waitlist Control Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 39 45
Mean (Full Range)
Unit of Measure: units on a scale
Baseline
20.4
(19.9 to 20.9)
20.3
(19.8 to 20.8)
8 weeks
11.9
(10.2 to 13.5)
18.0
(16.4 to 19.7)
16 weeks
10.7
(8.5 to 13.0)
12.0
(9.8 to 14.2)
24 weeks
10.4
(8.0 to 12.7)
10.1
(7.8 to 12.4)
2.Secondary Outcome
Title Response Rate
Hide Description Response 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.
Time Frame baseline, 8 weeks, 16 weeks, and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spirituality Group Waitlist Control Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 39 45
Measure Type: Number
Unit of Measure: percentage of participants with response
8 weeks 35.9 4.4
16 weeks 56.4 51.1
24 weeks 64.1 66.7
3.Secondary Outcome
Title Remission
Hide Description Remission 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.
Time Frame baseline, 8 weeks, 16 weeks, and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spirituality Group Waitlist Control Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 39 45
Measure Type: Number
Unit of Measure: percentage of participants score < 7
8 weeks 30.7 2.2
16 weeks 38.5 31.1
24 weeks 41 53.3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Spirituality Group Waitlist Control Group
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Spirituality Group Waitlist Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Spirituality Group Waitlist Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)   0/45 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Spirituality Group Waitlist Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)   0/45 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Badri Rickhi
Organization: Canadian Institute of Natural and Integrative Medicine
Phone: 403-220-0022 ext 0
EMail: b.ricki@cinim.org
Layout table for additonal information
Responsible Party: Badri Rickhi, Canadian Institute of Natural and Integrative Medicine
ClinicalTrials.gov Identifier: NCT00322777     History of Changes
Other Study ID Numbers: Spirit II
First Submitted: May 4, 2006
First Posted: May 8, 2006
Results First Submitted: June 17, 2015
Results First Posted: March 3, 2016
Last Update Posted: March 3, 2016