N/A
N=84
Spirituality Teaching Program for Depressed Adults
Major Depression
Bottom Line
View on ClinicalTrials.gov: NCT00322777 ↗Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Hamilton Depression Rating Scale - Depression Severity — 20.4; 20.3; 11.9; 18.0 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Spirituality Teaching Program (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Canadian Institute of Natural and Integrative Medicine
- Primary completion
- Dec 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hamilton Depression Rating Scale - Depression Severity |
20.4; 20.3; 11.9; 18.0; 10.7; 12.0 | — |
| SECONDARY Response Rate |
35.9; 4.4; 56.4; 51.1; 64.1; 66.7 | — |
| SECONDARY Remission |
30.7; 2.2; 38.5; 31.1; 41; 53.3 | — |
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).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00322777). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.