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Spirituality Teaching Program for Depressed Adults

Primary Purpose

Major Depression

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Spirituality Teaching Program
Sponsored by
Canadian Institute of Natural and Integrative Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression focused on measuring Major depression, Spirituality, Randomized clinical trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Canadian Institute of Natural and Integrative Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Spirituality Group

Waitlist Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 4, 2006
Last Updated
February 4, 2016
Sponsor
Canadian Institute of Natural and Integrative Medicine
Collaborators
University of Calgary, Dept. of Psychiatry & Dept. of Community Health Sciences, Southwest Behavioral Health Sciences, Alberta Health services, Arizona School of Health Sciences, The Center for Mind-Body Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00322777
Brief Title
Spirituality Teaching Program for Depressed Adults
Official Title
A Spirituality Teaching Program for Depression in Adults: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Canadian Institute of Natural and Integrative Medicine
Collaborators
University of Calgary, Dept. of Psychiatry & Dept. of Community Health Sciences, Southwest Behavioral Health Sciences, Alberta Health services, Arizona School of Health Sciences, The Center for Mind-Body Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: whether the Spirituality Teaching Program is efficacious in improving depression severity, response rate, and remission rate in adults, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression
Keywords
Major depression, Spirituality, Randomized clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spirituality Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Spirituality Teaching Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale - Depression Severity
Description
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.
Time Frame
baseline, 8 weeks, 16 weeks, and 24 weeks
Secondary Outcome Measure Information:
Title
Response Rate
Description
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.
Time Frame
baseline, 8 weeks, 16 weeks, and 24 weeks
Title
Remission
Description
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.
Time Frame
baseline, 8 weeks, 16 weeks, and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Badri Rickhi, MD
Organizational Affiliation
Canadian Institute of Natural and Integrative Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Toews, MD
Organizational Affiliation
Canadian Institute of Natural and Integrative Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sabine Moritz, MSc
Organizational Affiliation
Alberta Health Services (current)
Official's Role
Study Director
Facility Information:
Facility Name
Canadian Institute of Natural and Integrative Medicine
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 1B9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21827934
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.
Results Reference
background
PubMed Identifier
22439299
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.
Results Reference
result

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Spirituality Teaching Program for Depressed Adults

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