Major DepressionNCT00322777

Spirituality Teaching Program for Depressed Adults

A study testing Spirituality Teaching Program in people with Major Depression, run by Canadian Institute of Natural and Integrative Medicine at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Major Depression
What is being tested?: Spirituality Teaching Program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 84 participants
Where: 1 siteCanada
Study dates: Jan 2005to Dec 2008
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

Canadian Institute of Natural and Integrative Medicine
Calgary, Alberta, T2N 1B9

Other trials in Canada

About this study

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

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).

Read the 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.

Conditions: Major Depression
Being tested: Spirituality Teaching Program
Keywords: Major depression, Spirituality, Randomized clinical trial
Medical subject headings: Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Spirituality Teaching ProgramBehavioural
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.

Study groups in NCT00322777
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Spirituality Teaching Program

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: baseline, 8 weeks, 16 weeks, and 24 weeks

Secondary outcomes (2)

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.
Measured: baseline, 8 weeks, 16 weeks, and 24 weeks
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.
Measured: baseline, 8 weeks, 16 weeks, and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2005Dec 2008

First posted8 May 2006 (estimated)
Study startJan 2005
Primary completionDec 2006
Study completionDec 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Major DepressionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00322777
Sponsor's protocol ID: Spirit II
Status last verified: Feb 2016
First submitted: 4 May 2006
Last updated: 3 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 21827934
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.
PubMed 22439299

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Major Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Spirituality Teaching Program for Depression in Adults: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT00322777
Acronym / sponsor ID: Spirit II
Conditions: Major Depression
Keywords: Major depression, Spirituality, Randomized clinical trial
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: Canadian Institute of Natural and Integrative MedicineUniversity, hospital or other
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
Study start: Jan 2005
Primary completion: Dec 2006 (actual)
Study completion: Dec 2008 (actual)
First posted: 8 May 2006 (estimated)
Results: Posted 3 Mar 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Spirituality Group	Experimental	Behavioral: Spirituality Teaching ProgramArm 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.
Waitlist Control Group	Active comparator	Behavioral: Spirituality Teaching ProgramArm 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Spirituality Teaching ProgramThe 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.	Behavioural	Spirituality Group, Waitlist Control Group

Primary outcome

Hamilton Depression Rating Scale - Depression Severity
Time frame: baseline, 8 weeks, 16 weeks, and 24 weeks
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.

2 secondary outcomes

Response Rate
Time frame: baseline, 8 weeks, 16 weeks, and 24 weeks
Remission
Time frame: baseline, 8 weeks, 16 weeks, and 24 weeks

Results and safety

Results posted to the registry on 3 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Spirituality Group	39	39
Waitlist Control Group	45	45

Primary outcome: Hamilton Depression Rating Scale - Depression Severity

Time frame: baseline, 8 weeks, 16 weeks, and 24 weeks. Mean (Full Range). Unit: units on a scale

Measure	Spirituality Group n = 39	Waitlist Control Group n = 45
Baseline	20.4 (19.9 to 20.9)	20.3 (19.8 to 20.8)
8 weeks	11.9 (10.2 to 13.5)	18.0 (16.4 to 19.7)
16 weeks	10.7 (8.5 to 13.0)	12.0 (9.8 to 14.2)
24 weeks	10.4 (8.0 to 12.7)	10.1 (7.8 to 12.4)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Spirituality Group	0 of 39 (0%)	0 of 39 (0%)	Not reported
Waitlist Control Group	0 of 45 (0%)	0 of 45 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21827934Moritz 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 publication: PubMed 22439299Rickhi 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.
Individual participant dataSharing planned: No

Related trials for Major Depression

RecruitingPhase 1
Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
Healthy Volunteer, Major Depressive Disorder
RecruitingObservational study
Characterization and Treatment of Adolescent Depression
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Recruiting
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RecruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Badri Rickhi, MD principal investigator

Canadian Institute of Natural and Integrative Medicine

John Toews, MD principal investigator

Canadian Institute of Natural and Integrative Medicine

Sabine Moritz, MSc study director

Alberta Health Services (current)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Spirituality Teaching Program in people with Major Depression, run by Canadian Institute of Natural and Integrative Medicine at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hamilton Depression Rating Scale - Depression Severity (time frame: baseline, 8 weeks, 16 weeks, and 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00322777, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2016; AzTrials last refreshed its copy on 27 Oct 2026.