Iwankapiya-Healing: Historical Trauma Practice and Group IPT for American Indians (NCT02124694) | Clinical Trial Compass
CompletedNot Applicable
Iwankapiya-Healing: Historical Trauma Practice and Group IPT for American Indians
United States84 participantsStarted 2013-04-22
Plain-language summary
This study will pilot an intervention that combines group Interpersonal Psychotherapy (IPT), an empirically-supported treatment, and the Historical Trauma and Unresolved Grief Intervention (HTUG), a Tribal Best Practice for American Indians. HTUG focuses on grief, depression, and trauma response resolution related to collective massive group trauma across generations, including the lifespan, for American Indians. We anticipate more positive responses to, and patient engagement in, the combined HTUG/IPT intervention than to IPT Only.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* American Indian adults
* Depression
* Co-occurring unresolved, prolonged or complicated grief included
* Co-occurring PTSD or other trauma response included
* Score of 16 on Hamilton Depression Scale and clinician assessment
* DSM 5 Substance Use Disorder Mild for alcohol or cannabis only or remission
Exclusion Criteria:
* Psychosis
* Personality disorder
* Bipolar disorder
* Severe vegetative depressive symptoms such as psychomotor retardation
* Acutely suicidal or homicidal individuals
* Mild, moderate or severe substance abuse disorder for amphetamines, methamphetamines, opioids, hallucinogens or inhalants.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in Hamilton Depression Scale from Baseline
Timeframe: Initial Screening, two mid-points (weeks 4 and 8), end of intervention (week 12) and follow up (8 weeks post intervention)