Iwankapiya-Healing: Historical Trauma Practice and Group IPT for American Indians

NCT02124694 | Completed DMC

• 1 other identifier: 1R34MH097834-01A1
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Changes in Hamilton Depression Scale from Baseline

  Scale commonly used in IPT studies to assess depressive symptoms and track change over time. The Ham -D24 (and other shorter versions) is a commonly used clinician-administered depression assessment scale. This HAM-D24 is a 24 item version that incorporates three new items that assess helplessness, hopelessness, and worthlessness. The measure is commonly used to rate the severity of, and change in, a patient's major depression. It includes 24 items rated on a scale from 0-2, 0-3, or 0-4, with a total score computed ranging from 0-75. An earlier version of the Hamilton Depression Rating Scale the HAM-D17 has the following psychometric properties: Cronbach's alphas have been found to range from 0.46 to 0.97; inter-rater reliability, Pearson's r ranged from 0.82 to 0.98; and the intraclass r ranged from 0.46 to 0.99. The HAM-D24 is believed to have similar psychometric properties.

  Initial Screening, two mid-points (weeks 4 and 8), end of intervention (week 12) and follow up (8 weeks post intervention)

Secondary Outcomes (8)

• Changes in the PCL PTSD Checklist

  Initial Screening, two mid-points (weeks 4 and 8), end of intervention (week 12) and follow up (8 weeks post intervention)

• Changes on the Historical Losses and Historical Losses Associated Symptoms Scales (HLS/HLAS)

  Baseline, end of intervention (12 weeks), and 8 weeks follow up post-intervention

• Changes in the Inventory of Complicated Grief (ICG)

  Baseline, end of intervention (12 weeks), and 8 weeks follow up post-intervention

• Inventory of Interpersonal Problems (IIP)

  Baseline, end of intervention (12 weeks), and 8 weeks follow up post-intervention

• Duke-UNC Functional Support Questionnaire

  Baseline, end of intervention (12 weeks), and 8 weeks follow up post-intervention

Other Outcomes (1)

• Indigenous Peoples Survey (IPS)

  Baseline

Study Arms (2)

HTUG and IPT

EXPERIMENTAL

This arm includes the Historical Trauma and Unresolved Grief intervention (HUTG) combined with group Interpersonal Psychotherapy (IPT).The HTUG/IPT arm is 12 two-hour sessions delivered weekly on average, except for weather delays, over 16 weeks. HTUG/IPT includes sessions on identifying relationship issues which may trigger depressive symptoms, using group support, and connecting the impact of collective tribal trauma and losses with personal lifespan and current losses. HTUG/IPT is aimed at reducing depressive symptoms related to interpersonal conflicts and grief. HTUG is a Tribal Best Practice which may serve to engage AI in IPT, an empirically supported treatment for depression.

Behavioral: HTUG

IPT Only

NO INTERVENTION

IPT is a standard empirically supported treatment. This IPT Only group is not receiving the experimental HTUG component and is being compared to the combined HTUG with IPT.

Interventions

HTUG BEHAVIORAL

HTUG is a group psychotherapy...

Also known as: Historical Trauma and Unresolved Grief Intervention

HTUG and IPT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico Department of Psychiatry Center for Rural and Community Behavioral Health

Albuquerque, New Mexico, 87131-0001, United States

Location

MeSH Terms

Conditions

Depression; Stress Disorders, Post-Traumatic; Historical Trauma; Prolonged Grief Disorder

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Psychological Trauma

Study Officials

• Maria Y Brave Heart, PhD

  University of New Mexico Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: April 28, 2014
• Study Start: April 22, 2013
• Primary Completion: January 24, 2018
• Study Completion: January 24, 2018
• Last Updated: May 24, 2022

Record last verified: 2016-05

Locations

US (1)