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| Name | Class |
|---|---|
| University of Calgary, Dept. of Psychiatry & Dept. of Community Health Sciences | UNKNOWN |
| Southwest Behavioral Health Sciences | UNKNOWN |
| Alberta Health services | OTHER |
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Major depression is a widely spread health problem in Canada. Recent research suggests a potential role for religion/spirituality in the prevention of and recovery from depression in adults. The purpose this study was to assess the efficacy of a home-based Spirituality Teaching Program for adults in the treatment of major depression. The objectives of the study were to determine:
Major depression is a widely spread health problem in Canada with a life time prevalence of 11% in men and 16% in women. A recent avenue of research suggests a role for religion/spirituality in the prevention of and recovery from depression. It has been hypothesized that religion/spirituality acts as a coping resource in distressing life situations including illness and loss and may address the struggles of depressed patients of feeling separated from their surrounding world, as well as from their inner self. Majority of the research conducted to date on this topic has been observational and focused on the religious denomination, primarily the Christian and Muslim faiths. However, given the distinction between spirituality and religion and since a growing portion of the Canadian population identifies themselves as nonreligious but spiritual (10), it is pertinent to explore whether there is a role for a nondenominational spiritual intervention as a mental health resource. Considering the burden of depression on an individual and social level and need for effective and accessible treatment options, evaluation of spirituality based approaches is highly relevant. This study aims to assess whether nurturing spiritual coping resources in a non-faith based way may play a therapeutic role in recovery from major depression in adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spirituality Group | Experimental | 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. |
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| Waitlist Control Group | Active Comparator | 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 did not complete the program and were instructed to carry out their day to day activities as before. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spirituality Teaching Program | Behavioral | The Spirituality Teaching Program is a home study program delivered through audio CDs over an 8-week period. The program consists of weekly 90 minute teaching sessions, based on the content of a workshop developed to assist users in developing a more spiritual outlook on life and coping resources. Using didactic comment and storytelling, the following spiritual concepts are addressed in the sessions: self-transcendence, connectedness, forgiveness, self-acceptance, detachment, compassion and gratitude. Each session concludes with a relevant guided visualization practice. In addition, a 15-minute progressive relaxation exercise is included that is to be used on a daily basis. The presented content is nondenominational to ensure compatibility with any beliefs participants may hold. |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Rating Scale - Depression Severity | 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. | baseline, 8 weeks, 16 weeks, and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | 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. | baseline, 8 weeks, 16 weeks, and 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Badri Rickhi, MD | Canadian Institute of Natural and Integrative Medicine | Principal Investigator |
| John Toews, MD | Canadian Institute of Natural and Integrative Medicine | Principal Investigator |
| Sabine Moritz, MSc | Alberta Health Services (current) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canadian Institute of Natural and Integrative Medicine | Calgary | Alberta | T2N 1B9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21827934 | Background | Moritz S, Kelly MT, Xu TJ, Toews J, Rickhi B. A spirituality teaching program for depression: qualitative findings on cognitive and emotional change. Complement Ther Med. 2011 Aug;19(4):201-7. doi: 10.1016/j.ctim.2011.05.006. Epub 2011 Jun 29. | |
| 22439299 | Result | Rickhi B, Moritz S, Reesal R, Xu TJ, Paccagnan P, Urbanska B, Liu MF, Ewing H, Toews J, Gordon J, Quan H. A spirituality teaching program for depression: a randomized controlled trial. Int J Psychiatry Med. 2011;42(3):315-29. doi: 10.2190/PM.42.3.f. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Waitlist Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hamilton Depression Rating Scale - Depression Severity | 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. | Posted | Mean | Full Range | units on a scale | baseline, 8 weeks, 16 weeks, and 24 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Badri Rickhi | Canadian Institute of Natural and Integrative Medicine | 403-220-0022 | 0 | b.ricki@cinim.org |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| Arizona School of Health Sciences |
| OTHER |
| The Center for Mind-Body Medicine | OTHER |
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| Remission | 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. | baseline, 8 weeks, 16 weeks, and 24 weeks |
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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Marital Status | Number | participants |
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| Education | Number | participants |
|
| Employment status | Number | participants |
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| Religious denomination | Number | participants |
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| Interest in spirituality | Number | 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.
| OG001 | 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. |
|
|
| Secondary | Response Rate | 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. | Posted | Number | percentage of participants with response | baseline, 8 weeks, 16 weeks, and 24 weeks |
|
|
|
| Secondary | Remission | 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. | Posted | Number | percentage of participants score < 7 | baseline, 8 weeks, 16 weeks, and 24 weeks |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | 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. | 0 | 45 | 0 | 45 |
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| 24 weeks |
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| 24 weeks |
|