Anxiety DisorderNCT00225459
Does Spiritual/Religious Commitment Mediate the Relationship Between Mood Variability and Suicidal Ideation.
An observational study of Anxiety Disorder and Mood Disorder, run by University of Saskatchewan at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether or not spiritual and/or religious commitment affects mood variability and thoughts of suicide. First we hypothesize that among patients with depressive symptoms, those who have higher religious/spiritual (R/S) commitment will have less suicidal ideation and less mood… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anxiety Disorder, Mood Disorder
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2005to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is psychiatric inpatients and outpatients with depressive symptoms between the ages or 18 and 70. Co-morbid anxiety, bipolar spectrum, and eating disorders will be allowed. Involuntary patients and those with psychosis, organic brain impairment, and current substance dependence will be excluded. We will recruit patients prospectively, as they attend psychiatrists' clinics and are admitted to hospital.
Who may be able to join
- Inpatients and outpatients.
- DSM-IV defined major depression.
- Comorbid anxiety, bipolar spectrum, and schizoaffective (depressive type).
- Males and females between the ages of 18 and 70.
Who cannot join
- Involuntary patients.
- In/out patients with current psychosis.
- In/out patients with neurological impairment.
- In/out patients with current substance dependence.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Saskatchewan Department of Psychiatry
Saskatoon, Saskatchewan, S7N 0W8
About this study
The purpose of this study is to determine whether or not spiritual and/or religious commitment affects mood variability and thoughts of suicide.
First we hypothesize that among patients with depressive symptoms, those who have higher religious/spiritual (R/S) commitment will have less suicidal ideation and less mood variability. Second, we hypothesize that higher mood variability will be associated with more suicidal ideation. Finally, dependent on the first two hypotheses, we propose that R/S commitment will mediate the relationship between mood variability and suicidal ideation.
Read the detailed description
The suicide rate has not changed dramatically in the recent past, despite advances in psychiatric and mental health treatment, suicide prevention and awareness programs, and reorganization of health services. Depression and the mood disorders which may affect 15% of the population are the conditions most associated with high suicide rates (in addition to psychotic conditions that are relatively rare). Research findings into specific conditions within the depressive disorders that might predict suicidal tendencies are sparse, except for other common comorbid conditions such as panic and alcohol abuse. Research into risks and protective factors has infrequently included religious and spiritual variables that have been associated with decreased rates of depression, suicide, suicide attempts and suicidal ideation.
An inverse relationship between religion and suicide has been found in regional, national, and cross-national studies. Analyzing data from the 1993 Mortality Followback Survey in the US, frequency of religious activities reduced the odds of dying by suicide even after controlling for the frequency of social contact; in 584 deaths by suicide compared with 4279 natural deaths. A Canadian study of 261 Census divisions found the absence of religious affiliation to be an important predictor of death by suicide.
There are no known studies examining mood variability and religion, or spirituality directly. A number of studies however have examined personality attributes and religiosity. The personality style of neuroticism includes moodiness and negative emotionality with the concept of mood reactivity being germane to its construct. Neuroticism is highly correlated with depression and may be a higher order factor in the "internalizing disorders" which include the depressive and anxiety disorders.
The objective of this study is to answer the question "Does R/S mediate the relationship between mood variability and suicidal ideation?" In an effort to achieve that objective, there are three questions that must be answered in this population which in themselves are significant contributions to the research literature.
- Is there an association between mood variability and suicidal ideation?
- Is there an association between mood variability and religion?
- Is there an association between religion and suicidal ideation?
We hypothesize that those who endorses higher religious/spiritual commitment as measured by daily spiritual experiences, positive religious coping, and personal devotion, will have less suicidal ideation, and less mood variability. Secondly, we hypothesize that higher mood variability will be associated with more suicidal ideation. Finally, dependent on the first two hypotheses, we propose that R/S commitment will mediate the relationship between mood variability and suicidal ideation.
- Conditions
- Anxiety Disorder, Mood Disorder
- Keywords
- Religious psychology, Anxiety disorder, Mood disorder, Suicide
- Medical subject headings
- Anxiety Disorders, Mood Disorders, Suicide
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study startJun 2005
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisorderStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Saskatoon Health Region
- Responsible party
- Principal investigator, Marilyn Baetz, University of Saskatchewan
- Investigators
- Marilyn Baetz, MD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225459
- Sponsor's protocol ID
- Beh-REB 05-18
- Status last verified
- Oct 2011
- First submitted
- 21 Sep 2005
- Last updated
- 5 Oct 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Spiritual/Religious Commitment Mediate the Relationship Between Mood Variability and Suicidal Ideation.
- ClinicalTrials.gov ID
- NCT00225459
- Acronym / sponsor ID
- Beh-REB 05-18
- Conditions
- Anxiety Disorder, Mood Disorder
- Keywords
- Religious psychology, Anxiety disorder, Mood disorder, Suicide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Saskatoon Health Region
- Study start
- Jun 2005
- Study completion
- Dec 2008 (actual)
- First posted
- 23 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether or not spiritual and/or religious commitment affects mood variability and thoughts of suicide.
First we hypothesize that among patients with depressive symptoms, those who have higher religious/spiritual (R/S) commitment will have less suicidal ideation and less mood variability. Second, we hypothesize that higher mood variability will be associated with more suicidal ideation. Finally, dependent on the first two hypotheses, we propose that R/S commitment will mediate the relationship between mood variability and suicidal ideation.
Detailed description
The suicide rate has not changed dramatically in the recent past, despite advances in psychiatric and mental health treatment, suicide prevention and awareness programs, and reorganization of health services. Depression and the mood disorders which may affect 15% of the population are the conditions most associated with high suicide rates (in addition to psychotic conditions that are relatively rare). Research findings into specific conditions within the depressive disorders that might predict suicidal tendencies are sparse, except for other common comorbid conditions such as panic and alcohol abuse. Research into risks and protective factors has infrequently included religious and spiritual variables that have been associated with decreased rates of depression, suicide, suicide attempts and suicidal ideation.
An inverse relationship between religion and suicide has been found in regional, national, and cross-national studies. Analyzing data from the 1993 Mortality Followback Survey in the US, frequency of religious activities reduced the odds of dying by suicide even after controlling for the frequency of social contact; in 584 deaths by suicide compared with 4279 natural deaths. A Canadian study of 261 Census divisions found the absence of religious affiliation to be an important predictor of death by suicide.
There are no known studies examining mood variability and religion, or spirituality directly. A number of studies however have examined personality attributes and religiosity. The personality style of neuroticism includes moodiness and negative emotionality with the concept of mood reactivity being germane to its construct. Neuroticism is highly correlated with depression and may be a higher order factor in the "internalizing disorders" which include the depressive and anxiety disorders.
The objective of this study is to answer the question "Does R/S mediate the relationship between mood variability and suicidal ideation?" In an effort to achieve that objective, there are three questions that must be answered in this population which in themselves are significant contributions to the research literature.
- Is there an association between mood variability and suicidal ideation?
- Is there an association between mood variability and religion?
- Is there an association between religion and suicidal ideation?
We hypothesize that those who endorses higher religious/spiritual commitment as measured by daily spiritual experiences, positive religious coping, and personal devotion, will have less suicidal ideation, and less mood variability. Secondly, we hypothesize that higher mood variability will be associated with more suicidal ideation. Finally, dependent on the first two hypotheses, we propose that R/S commitment will mediate the relationship between mood variability and suicidal ideation.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is psychiatric inpatients and outpatients with depressive symptoms between the ages or 18 and 70. Co-morbid anxiety, bipolar spectrum, and eating disorders will be allowed. Involuntary patients and those with psychosis, organic brain impairment, and current substance dependence will be excluded. We will recruit patients prospectively, as they attend psychiatrists' clinics and are admitted to hospital.
Key inclusion criteria (4 listed)
- Inpatients and outpatients.
- DSM-IV defined major depression.
- Comorbid anxiety, bipolar spectrum, and schizoaffective (depressive type).
- Males and females between the ages of 18 and 70.
Key exclusion criteria (4 listed)
- Involuntary patients.
- In/out patients with current psychosis.
- In/out patients with neurological impairment.
- In/out patients with current substance dependence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2011.
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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.
Marilyn Baetz, MD principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety Disorder and Mood Disorder, run by University of Saskatchewan 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 4 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 5 Oct 2011. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
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 5 Oct 2011.