Major Depression
Conditions
Keywords
Major depression, Spirituality, Randomized clinical trial
Brief summary
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: 1. whether the Spirituality Teaching Program is efficacious in improving depression severity, response rate, and remission rate in adults, 2. whether efficacy is maintained long term (over a 16 week period).
Detailed description
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.
Interventions
BEHAVIORALSpirituality Teaching Program
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.
Sponsors
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
Canadian Institute of Natural and Integrative Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Satisfy the DSM-IV criteria for unipolar major depression with a depression score of 18-22 on the Hamilton Depression Scale (mild to moderate severity), * Are at least 18 years of age, * Have the competence to understand the study requirements and the ability to comply with the study intervention, * Have provided written informed consent.
Exclusion criteria
* History of treatment resistance to two or more antidepressants when treated for an adequate period with a therapeutic dose * History of bipolar d/o, psychotic d/o, any psychotic episodes, personality d/o (except obsessive compulsive d/o) * History of multiple suicide attempts * Acute psychiatric condition other than unipolar depression * Regular use of medications (other than antidepressant, if applicable) that have mood altering effects, such as narcotics, anticonvulsants, illicit drugs or sleeping pills * Uncontrolled medical conditions in the last 3 months * DSM-IV diagnosis of substance abuse (except nicotine and caffeine) within the past 12-months * High suicide risk
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Rating Scale - Depression Severity | baseline, 8 weeks, 16 weeks, and 24 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Remission | baseline, 8 weeks, 16 weeks, and 24 weeks | 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. |
| Response Rate | baseline, 8 weeks, 16 weeks, and 24 weeks | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 39 |
| 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. | 45 |
| Total | 84 |
Baseline characteristics
| Characteristic | Waitlist Control Group | Total | Spirituality Group |
|---|---|---|---|
| Age, Continuous | 44.0 years STANDARD_DEVIATION 9.14 | 44.02 years STANDARD_DEVIATION 9.92 | 44.1 years STANDARD_DEVIATION 10.86 |
| Education graduated from college or university | 24 participants | 46 participants | 22 participants |
| Education less than or equal to Highschool | 7 participants | 12 participants | 5 participants |
| Education Not available | 0 participants | 1 participants | 1 participants |
| Education Postgraduate or professional degree | 6 participants | 8 participants | 2 participants |
| Education Some college or university | 8 participants | 17 participants | 9 participants |
| Employment status No paid work | 12 participants | 20 participants | 8 participants |
| Employment status Paid work | 33 participants | 64 participants | 31 participants |
| Interest in spirituality A little interested | 3 participants | 7 participants | 4 participants |
| Interest in spirituality Quite interested | 12 participants | 23 participants | 11 participants |
| Interest in spirituality Very interested | 30 participants | 54 participants | 24 participants |
| Marital Status Married/common law | 22 participants | 49 participants | 27 participants |
| Marital Status Not married | 23 participants | 35 participants | 12 participants |
| Religious denomination Christian | 25 participants | 47 participants | 22 participants |
| Religious denomination No religion | 16 participants | 30 participants | 14 participants |
| Religious denomination Other | 4 participants | 7 participants | 3 participants |
| Sex: Female, Male Female | 36 Participants | 65 Participants | 29 Participants |
| Sex: Female, Male Male | 9 Participants | 19 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 39 | 0 / 45 |
| serious Total, serious adverse events | 0 / 39 | 0 / 45 |
Outcome results
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.
Time frame: baseline, 8 weeks, 16 weeks, and 24 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Spirituality Group | Hamilton Depression Rating Scale - Depression Severity | Baseline | 20.4 units on a scale |
| Spirituality Group | Hamilton Depression Rating Scale - Depression Severity | 8 weeks | 11.9 units on a scale |
| Spirituality Group | Hamilton Depression Rating Scale - Depression Severity | 16 weeks | 10.7 units on a scale |
| Spirituality Group | Hamilton Depression Rating Scale - Depression Severity | 24 weeks | 10.4 units on a scale |
| Waitlist Control Group | Hamilton Depression Rating Scale - Depression Severity | 24 weeks | 10.1 units on a scale |
| Waitlist Control Group | Hamilton Depression Rating Scale - Depression Severity | Baseline | 20.3 units on a scale |
| Waitlist Control Group | Hamilton Depression Rating Scale - Depression Severity | 16 weeks | 12.0 units on a scale |
| Waitlist Control Group | Hamilton Depression Rating Scale - Depression Severity | 8 weeks | 18.0 units on a scale |
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.
Time frame: baseline, 8 weeks, 16 weeks, and 24 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spirituality Group | Remission | 8 weeks | 30.7 percentage of participants score < 7 |
| Spirituality Group | Remission | 16 weeks | 38.5 percentage of participants score < 7 |
| Spirituality Group | Remission | 24 weeks | 41 percentage of participants score < 7 |
| Waitlist Control Group | Remission | 8 weeks | 2.2 percentage of participants score < 7 |
| Waitlist Control Group | Remission | 16 weeks | 31.1 percentage of participants score < 7 |
| Waitlist Control Group | Remission | 24 weeks | 53.3 percentage of participants score < 7 |
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.
Time frame: baseline, 8 weeks, 16 weeks, and 24 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spirituality Group | Response Rate | 8 weeks | 35.9 percentage of participants with response |
| Spirituality Group | Response Rate | 16 weeks | 56.4 percentage of participants with response |
| Spirituality Group | Response Rate | 24 weeks | 64.1 percentage of participants with response |
| Waitlist Control Group | Response Rate | 8 weeks | 4.4 percentage of participants with response |
| Waitlist Control Group | Response Rate | 16 weeks | 51.1 percentage of participants with response |
| Waitlist Control Group | Response Rate | 24 weeks | 66.7 percentage of participants with response |