AnxietyB2WNCT00749177
Blending Two Worlds: Traditional Aboriginal Healing Strategies for Depression and Anxiety
A study testing Traditional Healing options in people with Anxiety and Depression, run by Fraser Health at 1 site in Canada.
Trial summary
1. Purpose 1. Provide a culturally sensitive and supportive treatment environment for children, youth and families in the aboriginal community experiencing stress, anxiety and depression. 2. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Traditional Healing options
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2008to Aug 2011
- Phase
- Interventional
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children and adolescents (less than 18 years of age)and families with anxiety and/or depression attending the Surrey North Child and Youth Mental Health Team.
Who cannot join
- Subjects with severe anxiety or depression requiring intervention (i.e. hospitalization) or have a past or present history of suicide attempt. Subjects with special needs including medical contraindications (i.e. medical conditions including pregnancy), brain injury, developmental disability or fetal alcohol syndrome). Those subjects unwilling or unable to participate in a Traditional Healing options.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Child and Youth Mental Health, Surrey North
Surrey, British Columbia, V3T 2B3
About this study
Official title: Blending Two Worlds: Traditional Aboriginal Healing Strategies for Depression and Anxiety. Possible Options for Children, Youth and Families
- Purpose
- Provide a culturally sensitive and supportive treatment environment for children, youth and families in the aboriginal community experiencing stress, anxiety and depression.
- Gain insight into understanding of the role of Traditional Healing options provided by Aboriginal Healers and Helpers in the management of stress, anxiety and depression.
- Encourage Aboriginal and First Nation clients to seek treatment earlier from a culturally supportive system.
- Hypothesis
This will be a descriptive hypothesis generating research project, however it is anticipated that members of the Aboriginal community experiencing stress, anxiety and depression may experience improved care and outcomes if their treatment includes traditional healing methods. A number of measures of subject and treatment characteristics, stress, anxiety and depression will provide the foundation for triangulation of outcomes in order to describe the impact of the various treatment options (standard care, Traditional Healing, combined standard care and Traditional Healing).
Read the detailed description
Aboriginal clients, including first nation youth, may not be confident or comfortable with the standard treatments offered by the current Mental Health environment. Incorporating traditional aboriginal healing methods such as dream work, energy healing, healing circles, pipe ceremonies, self care, smudging, sweat lodge and traditional learning into standard practice will provide a culturally sensitive and supportive environment for children, youth and families experiencing stress, anxiety and depression.
It is believed that Aboriginal and First Nation clients that access treatment options consistent with cultural beliefs will be encouraged to seek treatment earlier and will experience improved care and outcomes.
In addition, the improved understanding of the role of traditional healing methods provided by Aboriginal Healers and Helpers in the management of these disorders will help clinicians incorporate these practices in the management of anxiety and depression
- Conditions
- Anxiety, Depression
- Being tested
- Traditional Healing options
- Keywords
- traditional healing, anxiety, depression, aboriginal, children, youth
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Healing optionsOther
Dream work, energy healing, healing circles, pipe ceremonies, self care, smudging, sweat lodges and traditional learning.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Traditional Healing arm Provides Traditional Healing options only Receives: Other: Traditional Healing options |
| 3 | Active comparator | Traditional Healing and usual standard of care arm Subjects will access both treatment options Receives: Other: Traditional Healing options |
| 1 | Active comparator | Treatment as usual Receives: Other: Traditional Healing options |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provide Aboriginal and First Nation youth and their families with treatment options consistent with cultural beliefs. Improving outcomes in the management of anxiety and depression.
Measured: Within one year
Secondary outcomes (1)
1. Encourage Aboriginal and First Nation clients to seek treatment earlier from a culturally supportive system. 2. Validate the benefit of traditional diet and healing methods in the treatment of stress, anxiety and depression
Measured: Within 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
- Study startNov 2008
- Primary completionAug 2011
- Study completionAug 2011
Why it stopped: Primary investigator left program: unable to recruit a replacement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraser Health
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Children and Family Development, British Columbia
- Responsible party
- Principal investigator, Debbie Thompson, Fraser Health
- Investigators
- Deborah L Thompson, BScPharm, BCPP, PharmD, Principal investigator, Fraser Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00749177
- Sponsor's protocol ID
- FHA-MHA-B2W
- Acronym
- B2W
- Status last verified
- Mar 2015
- First submitted
- 5 Sep 2008
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hunter L, Logan J, Barton S, Goulet JG. Linking aboriginal healing traditions to holistic nursing practice. J Holist Nurs. 2004 Sep;22(3):267-85. doi: 10.1177/0898010104266750.
PubMed 15296579Dapice AN. The medicine wheel. J Transcult Nurs. 2006 Jul;17(3):251-60. doi: 10.1177/1043659606288383.
PubMed 16757664Struthers R, Hodge FS. Sacred tobacco use in Ojibwe communities. J Holist Nurs. 2004 Sep;22(3):209-25. doi: 10.1177/0898010104266735.
PubMed 15296576Buehler JA. Traditional Crow Indian health beliefs and practices. Toward a grounded theory. J Holist Nurs. 1992 Mar;10(1):18-33. doi: 10.1177/089801019201000104.
PubMed 1293200Zubek EM. Traditional Native healing. Alternative or adjunct to modern medicine? Can Fam Physician. 1994 Nov;40:1923-31.
PubMed 7841824Buchwald D, Beals J, Manson SM. Use of traditional health practices among Native Americans in a primary care setting. Med Care. 2000 Dec;38(12):1191-9. doi: 10.1097/00005650-200012000-00006.
PubMed 11186298
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blending Two Worlds: Traditional Aboriginal Healing Strategies for Depression and Anxiety. Possible Options for Children, Youth and Families
- ClinicalTrials.gov ID
- NCT00749177
- Acronym / sponsor ID
- B2W / FHA-MHA-B2W
- Conditions
- Anxiety, Depression
- Keywords
- traditional healing, anxiety, depression, aboriginal, children, youth
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Primary investigator left program: unable to recruit a replacement
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Fraser HealthUniversity, hospital or other
- Collaborators
- Ministry of Children and Family Development, British Columbia
- Study start
- Nov 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 9 Sep 2008 (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.
- Purpose
- Provide a culturally sensitive and supportive treatment environment for children, youth and families in the aboriginal community experiencing stress, anxiety and depression.
- Gain insight into understanding of the role of Traditional Healing options provided by Aboriginal Healers and Helpers in the management of stress, anxiety and depression.
- Encourage Aboriginal and First Nation clients to seek treatment earlier from a culturally supportive system.
- Hypothesis
This will be a descriptive hypothesis generating research project, however it is anticipated that members of the Aboriginal community experiencing stress, anxiety and depression may experience improved care and outcomes if their treatment includes traditional healing methods. A number of measures of subject and treatment characteristics, stress, anxiety and depression will provide the foundation for triangulation of outcomes in order to describe the impact of the various treatment options (standard care, Traditional Healing, combined standard care and Traditional Healing).
Detailed description
Aboriginal clients, including first nation youth, may not be confident or comfortable with the standard treatments offered by the current Mental Health environment. Incorporating traditional aboriginal healing methods such as dream work, energy healing, healing circles, pipe ceremonies, self care, smudging, sweat lodge and traditional learning into standard practice will provide a culturally sensitive and supportive environment for children, youth and families experiencing stress, anxiety and depression.
It is believed that Aboriginal and First Nation clients that access treatment options consistent with cultural beliefs will be encouraged to seek treatment earlier and will experience improved care and outcomes.
In addition, the improved understanding of the role of traditional healing methods provided by Aboriginal Healers and Helpers in the management of these disorders will help clinicians incorporate these practices in the management of anxiety and depression
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Other: Traditional Healing optionsTraditional Healing arm Provides Traditional Healing options only |
| 3 | Active comparator | Other: Traditional Healing optionsTraditional Healing and usual standard of care arm Subjects will access both treatment options |
| 1 | Active comparator | Other: Traditional Healing optionsTreatment as usual |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- children and adolescents (less than 18 years of age)and families with anxiety and/or depression attending the Surrey North Child and Youth Mental Health Team.
Key exclusion criteria (1 listed)
- Subjects with severe anxiety or depression requiring intervention (i.e. hospitalization) or have a past or present history of suicide attempt. Subjects with special needs including medical contraindications (i.e. medical conditions including pregnancy), brain injury, developmental disability or fetal alcohol syndrome). Those subjects unwilling or unable to participate in a Traditional Healing options.
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 |
|---|---|---|
| Traditional Healing optionsDream work, energy healing, healing circles, pipe ceremonies, self care, smudging, sweat lodges and traditional learning. | Other | 1, 2, 3 |
Primary outcome
Provide Aboriginal and First Nation youth and their families with treatment options consistent with cultural beliefs. Improving outcomes in the management of anxiety and depression.
Time frame: Within one year
1 secondary outcome
1. Encourage Aboriginal and First Nation clients to seek treatment earlier from a culturally supportive system. 2. Validate the benefit of traditional diet and healing methods in the treatment of stress, anxiety and depression
Time frame: Within 2 years
Results and safety
The study was stopped early (reason given: Primary investigator left program: unable to recruit a replacement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
- Background: PubMed 15296579Hunter L, Logan J, Barton S, Goulet JG. Linking aboriginal healing traditions to holistic nursing practice. J Holist Nurs. 2004 Sep;22(3):267-85. doi: 10.1177/0898010104266750.
- Background: PubMed 16757664Dapice AN. The medicine wheel. J Transcult Nurs. 2006 Jul;17(3):251-60. doi: 10.1177/1043659606288383.
- Background: PubMed 15296576Struthers R, Hodge FS. Sacred tobacco use in Ojibwe communities. J Holist Nurs. 2004 Sep;22(3):209-25. doi: 10.1177/0898010104266735.
- Background: PubMed 1293200Buehler JA. Traditional Crow Indian health beliefs and practices. Toward a grounded theory. J Holist Nurs. 1992 Mar;10(1):18-33. doi: 10.1177/089801019201000104.
- Background: PubMed 7841824Zubek EM. Traditional Native healing. Alternative or adjunct to modern medicine? Can Fam Physician. 1994 Nov;40:1923-31.
- Background: PubMed 11186298Buchwald D, Beals J, Manson SM. Use of traditional health practices among Native Americans in a primary care setting. Med Care. 2000 Dec;38(12):1191-9. doi: 10.1097/00005650-200012000-00006.
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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.
Deborah L Thompson, BScPharm, BCPP, PharmD principal investigator
Fraser Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Healing options in people with Anxiety and Depression, run by Fraser Health 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 6 Mar 2015. 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 was stopped early (reason given: Primary investigator left program: unable to recruit a replacement). Results are not available in the source record.
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?
Provide Aboriginal and First Nation youth and their families with treatment options consistent with cultural beliefs. Improving outcomes in the management of anxiety and depression. (time frame: Within one year). 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 NCT00749177, which also lists 6 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 6 Mar 2015.