Spirituality Teaching Program for Depressed Adults

Major Depression Clinical Trial

Official title:

A Spirituality Teaching Program for Depression in Adults: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00322777
• Other study ID #: Spirit II
• Status: Completed
• Phase: N/A
• First received: May 4, 2006
• Last updated: February 4, 2016
• Start date: January 2005
• Est. completion date: December 2008

Study information

• Verified date: February 2016
• Source: Canadian Institute of Natural and Integrative Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 2008
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

Behavioral:
• Spirituality 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.

Locations

Country	Name	City	State
Canada	Canadian Institute of Natural and Integrative Medicine	Calgary	Alberta

Sponsors (6)

Lead Sponsor	Collaborator
Canadian Institute of Natural and Integrative Medicine	A.T. Still University, Arizona School of Health Sciences, Alberta Health Services, Southwest Behavioral Health Sciences, The Center for Mind-Body Medicine, University of Calgary, Dept. of Psychiatry & Dept. of Community Health Sciences

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	baseline, 8 weeks, 16 weeks, and 24 weeks	No
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.	baseline, 8 weeks, 16 weeks, and 24 weeks	No
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.	baseline, 8 weeks, 16 weeks, and 24 weeks	No