NCT00322777

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. 1.whether the Spirituality Teaching Program is efficacious in improving depression severity, response rate, and remission rate in adults,
  2. 2.whether efficacy is maintained long term (over a 16 week period).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
7.3 years until next milestone

Results Posted

Study results publicly available

March 3, 2016

Completed
Last Updated

March 3, 2016

Status Verified

February 1, 2016

Enrollment Period

1.9 years

First QC Date

May 4, 2006

Results QC Date

June 17, 2015

Last Update Submit

February 4, 2016

Conditions

Major Depression

Keywords

Major depressionSpiritualityRandomized clinical trial

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Response Rate

    baseline, 8 weeks, 16 weeks, and 24 weeks

  • Remission

    baseline, 8 weeks, 16 weeks, and 24 weeks

Study Arms (2)

Spirituality Group

EXPERIMENTAL

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

Waitlist Control Group

ACTIVE COMPARATOR

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

Interventions

Spirituality Teaching ProgramBEHAVIORAL

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.

Spirituality GroupWaitlist Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Canadian Institute of Natural and Integrative Medicine

Calgary, Alberta, T2N 1B9, Canada

Location

Related 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.

    PMID: 21827934BACKGROUND

  • 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.

    PMID: 22439299RESULT

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Results Point of Contact

Title
Dr. Badri Rickhi
Organization
Canadian Institute of Natural and Integrative Medicine
b.ricki@cinim.org
403-220-0022

Study Officials

  • Badri Rickhi, MD

    Canadian Institute of Natural and Integrative Medicine

    PRINCIPAL INVESTIGATOR

  • John Toews, MD

    Canadian Institute of Natural and Integrative Medicine

    PRINCIPAL INVESTIGATOR

  • Sabine Moritz, MSc

    Alberta Health Services (current)

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair and Founding Member, CINIM

Study Record Dates

First Submitted

May 4, 2006

First Posted

May 8, 2006

Study Start

January 1, 2005

Primary Completion

December 1, 2006

Study Completion

December 1, 2008

Last Updated

March 3, 2016

Results First Posted

March 3, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)