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Spirituality Teaching Program for Depressed Adults

This study has been completed.
Sponsor:
Collaborators:
University of Calgary, Dept. of Psychiatry & Dept. of Community Health Sciences
Southwest Behavioral Health Sciences
Alberta Health Services
A.T. Still University, Arizona School of Health Sciences
The Center for Mind-Body Medicine
Information provided by (Responsible Party):
Badri Rickhi, Canadian Institute of Natural and Integrative Medicine
ClinicalTrials.gov Identifier:
NCT00322777
First received: May 4, 2006
Last updated: February 4, 2016
Last verified: February 2016
  Purpose

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).

Condition Intervention
Major Depression
Behavioral: Spirituality Teaching Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Spirituality Teaching Program for Depression in Adults: A Randomized Controlled Trial

Further study details as provided by Canadian Institute of Natural and Integrative Medicine:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale - Depression Severity [ Time Frame: baseline, 8 weeks, 16 weeks, and 24 weeks ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Response Rate [ Time Frame: baseline, 8 weeks, 16 weeks, and 24 weeks ] [ Designated as safety issue: No ]
    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.

  • Remission [ Time Frame: baseline, 8 weeks, 16 weeks, and 24 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 84
Study Start Date: January 2005
Study Completion Date: December 2008
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of Calgary, Dept. of Psychiatry & Dept. of Community Health Sciences
Southwest Behavioral Health Sciences
Alberta Health Services
A.T. Still University, Arizona School of Health Sciences
The Center for Mind-Body Medicine
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)
  More Information

Publications:
Responsible Party: Badri Rickhi, Chair and Founding Member, CINIM, Canadian Institute of Natural and Integrative Medicine
ClinicalTrials.gov Identifier: NCT00322777     History of Changes
Other Study ID Numbers: Spirit II 
Study First Received: May 4, 2006
Results First Received: June 17, 2015
Last Updated: February 4, 2016
Health Authority: Canada: Health Canada
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Canadian Institute of Natural and Integrative Medicine:
Major depression
Spirituality
Randomized clinical trial

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 23, 2016