Clinical trial NCT02124694: Iwankapiya-Healing: Historical Trauma Practice and Group IPT for American Indians
Official title: Iwankapiya-Healing: Historical Trauma Practice and Group IPT for American Indians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Grief
PTSD
Interpersonal Relations
Keywords: historical trauma and unresolved grief
complicated grief
prolonged grief
interpersonal conflicts
depression
American Indians
interpersonal psychotherapy
traumatic grief
posttraumatic stress disorder
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2014-04-28
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: In this pilot study (R34), we will explore the feasibility, acceptance and sustainability of a treatment engagement and retention strategy that combines the Historical Trauma and Unresolved Grief Tribal Best Practice (HTUG) and Group Interpersonal Psychotherapy (IPT). HTUG is designed to engage and retain American Indian (AI) adults in treatment by focusing on grief resolution related to AI collective massive group trauma across generations. The model has potential for engaging AIs in empirically supported or evidence based treatments (EBTs) through the acknowledgment of the negative effects of colonialism on well-being and reducing the stigma of mental health problems. This study will test HTUG's potential to engage AIs in IPT, an EBT that may be particularly well suited for treating depression and related mental disorders in this population. IPT has demonstrated efficacy for treatment of depression and grief in diverse populations, and promising results to date with PTSD; however, to our knowledge, IPT has not been studied with AIs.

The specific aims for this proposal are:

1. Manualize, field test, and refine a combined group HTUG/IPT intervention model and related clinician training and research protocols. Under Aim 1, we will: a) develop HTUG/IPT model and initial manual, b) refine IPT for use with AIs, c) solicit AI Advisory Panel (AP) member and clinician review of models, d) prepare pilot measures, e) prepare HTUG/IPT training materials, and f) recruit and train providers.
2. Conduct a pilot randomized trial of HTUG/IPT compared to IPT Only at two sites (Albuquerque, New Mexico and Pine Ridge Indian Reservation, South Dakota) to further refine the manual and protocols, and assess the feasibility and acceptability of our procedures for conducting a subsequent large-scale clinical trial. Under Aim 2, we will conduct the randomized trial in two waves; we will: a) recruit participants, b) implement interventions and collect data, c) analyze data, and d) develop "products" - the finalized HTUG/IPT manual, an R01 proposal, conference presentations and manuscripts, and the final manual and data report to the two clinics.

Upon completion of these aims, we will have piloted methods and established the feasibility and acceptance of the HTUG/IPT intervention model, which will provide foundational data for an R01 to test strategies for improving engagement and retention of AIs in EBTs. What is learned in the proposed program of research could have significant promise for reducing disparities in mental health treatment and disease burden across AI populations and in culturally unique, disadvantaged and poorly served populations in general. Improving engagement and retention in culturally relevant EBTs among AIs is of great practical importance given the rates of lifetime prevalence of mental health disorders (ranging from 35% to 54%), the fact that mental health care for AIs is severely underfunded, and the reality that treatment research with AIs is sorely lacking.

Two sites are participating in this project in two different Indian Health Service (IHS) Areas: Southwest urban and Northern Plains reservation outpatient behavioral health clinics. These include First Nations Community HealthSource in the Albuquerque Area in New Mexico and Oglala Lakota College/Kyle Health Center on the Pine Ridge Reservation in the Aberdeen Area in South Dakota. Participants will be randomly assigned to either the IPT Only treatment or the combined HTUG/IPT group; both will be 12 two hour sessions of group intervention. We anticipate that the HTUG/IPT group will show increased positive response to the intervention as measured on a number of scales for depression, grief, and interpersonal functioning as well as satisfaction with the model. We will use the results to design a more in-depth randomized clinical trial (R01) at additional tribal sites.

Eligibility criteria: 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.

Primary outcomes:
measure: 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)
Secondary outcomes:
measure: Changes in the PCL PTSD Checklist
timeFrame: Initial Screening, two mid-points (weeks 4 and 8), end of intervention (week 12) and follow up (8 weeks post intervention)
measure: Changes on the Historical Losses and Historical Losses Associated Symptoms Scales (HLS/HLAS)
timeFrame: Baseline, end of intervention (12 weeks), and 8 weeks follow up post-intervention
measure: Changes in the Inventory of Complicated Grief (ICG)
timeFrame: Baseline, end of intervention (12 weeks), and 8 weeks follow up post-intervention
measure: Inventory of Interpersonal Problems (IIP)
timeFrame: Baseline, end of intervention (12 weeks), and 8 weeks follow up post-intervention
measure: Duke-UNC Functional Support Questionnaire
timeFrame: Baseline, end of intervention (12 weeks), and 8 weeks follow up post-intervention
measure: Medication Adherence Questionnaire
timeFrame: baseline, two mid-points (Week 4 and 8), end of intervetion and 8 week follow up
measure: Group Environment Scale
timeFrame: Two mid points (Weeks 4 and 8)
measure: Group Engagement Measure
timeFrame: Two mid points (Weeks 4 and 8)
Other outcomes:
measure: Indigenous Peoples Survey (IPS)
timeFrame: Baseline
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Department of Psychiatry Center for Rural and Community Behavioral Health
state: New Mexico
Study officials:
affiliation: University of New Mexico Department of Psychiatry
name: Maria Y Brave Heart, PhD
role: PRINCIPAL_INVESTIGATOR
References: