Spirituality and Depression Study

This study has been completed.
Sponsor:
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
  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

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
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
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 September 18, 2014