- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00322777
Spirituality Teaching Program for Depressed Adults
A Spirituality Teaching Program for Depression in Adults: A Randomized Controlled Trial
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:
- whether the Spirituality Teaching Program is efficacious in improving depression severity, response rate, and remission rate in adults,
- whether efficacy is maintained long term (over a 16 week period).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada, T2N 1B9
- Canadian Institute of Natural and Integrative Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
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.
|
ACTIVE_COMPARATOR: 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 did not complete the program and were instructed to carry out their day to day activities as before.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hamilton Depression Rating Scale - Depression Severity
Time Frame: 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. |
baseline, 8 weeks, 16 weeks, and 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response Rate
Time Frame: 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.
|
baseline, 8 weeks, 16 weeks, and 24 weeks
|
Remission
Time Frame: 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.
|
baseline, 8 weeks, 16 weeks, and 24 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Badri Rickhi, MD, Canadian Institute of Natural and Integrative Medicine
- Principal Investigator: John Toews, MD, Canadian Institute of Natural and Integrative Medicine
- Study Director: Sabine Moritz, MSc, Alberta Health Services (current)
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Spirit II
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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