Spirituality and Depression Study
This study has been completed.
Sponsor:
Canadian Institute of Natural and Integrative Medicine
Information provided by:
Canadian Institute of Natural and Integrative Medicine
ClinicalTrials.gov Identifier:
NCT00322777
First received: May 4, 2006
Last updated: July 29, 2010
Last verified: July 2010
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Purpose
The purpose of this study is to assess the efficacy of a spirituality teaching programme for unipolar major depression. Using a randomized controlled trial design it will be assessed 1) whether the programme is efficacious in improving depression severity, response rates, remission rates and quality of life and 2) whether the efficacy is maintained long term (at least half a year).
| Condition | Intervention |
|---|---|
|
Unipolar Depression |
Behavioral: Spirituality Teaching Programme on CDs |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | A Spirituality Teaching Programme for Depression: A Randomized Controlled Trial |
Resource links provided by NLM:
Further study details as provided by Canadian Institute of Natural and Integrative Medicine:
Primary Outcome Measures:
- Hamilton Depression Rating Scale (HAMD) at the end of 8 weeks
- Profile of Mood Scale (POMS) at the end of 8 weeks
- SF36 Health Survey at the end of 8 weeks
Secondary Outcome Measures:
- Hamilton Depression Rating Scale (HAMD) at the end of 16 and 24 weeks
- Profile of Mood Scale (POMS) at the end of 16 and 24 weeks
- SF36 Health Survey at the end of 16 and 24 weeks
| Estimated Enrollment: | 78 |
| Study Start Date: | January 2005 |
| Study Completion Date: | December 2008 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00322777
Locations
| Canada, Alberta | |
| Canadian Institute of Natural and Integrative Medicine | |
| Calgary, Alberta, Canada, T2N 1B9 | |
Sponsors and Collaborators
Canadian Institute of Natural and Integrative Medicine
Investigators
| Principal Investigator: | Sabine Moritz, MSc | Canadian Institute of Natural and Integrative Medicine |
| Principal Investigator: | Badri Rickhi, MD | Canadian Institute of Natural and Integrative Medicine |
| Study Director: | Hude Quan, PhD | University of Calgary |
| Study Director: | Robin Reesal, MD | Centre for Depression and Anxiety |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00322777 History of Changes |
| Other Study ID Numbers: | Spirit II |
| Study First Received: | May 4, 2006 |
| Last Updated: | July 29, 2010 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Canadian Institute of Natural and Integrative Medicine:
|
Depression Spirituality |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on October 16, 2012
