Clinical trial NCT00322777: Spirituality Teaching Program for Depressed Adults
Official title: A Spirituality Teaching Program for Depression in Adults: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depression
Keywords: Major depression
Spirituality
Randomized clinical trial
Lead sponsor: Canadian Institute of Natural and Integrative Medicine
Sponsor class: OTHER
Collaborators: name: University of Calgary, Dept. of Psychiatry & Dept. of Community Health Sciences
name: Southwest Behavioral Health Sciences
name: Alberta Health services
name: Arizona School of Health Sciences
name: The Center for Mind-Body Medicine
First posted: 2006-05-08
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hamilton Depression Rating Scale - Depression Severity
timeFrame: baseline, 8 weeks, 16 weeks, and 24 weeks
Secondary outcomes:
measure: Response Rate
timeFrame: baseline, 8 weeks, 16 weeks, and 24 weeks
measure: Remission
timeFrame: baseline, 8 weeks, 16 weeks, and 24 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Canadian Institute of Natural and Integrative Medicine
state: Alberta
Study officials:
affiliation: Canadian Institute of Natural and Integrative Medicine
name: Badri Rickhi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Canadian Institute of Natural and Integrative Medicine
name: John Toews, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alberta Health Services (current)
name: Sabine Moritz, MSc
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.