DepressionHTUG-IPTNCT02124694
Iwankapiya-Healing: Historical Trauma Practice and Group IPT for American Indians
A study testing HTUG in people with Depression and Grief, run by University of New Mexico at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Grief, PTSD
- What is being tested?
- HTUG
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2013to 24 Jan 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico Department of Psychiatry Center for Rural and Community Behavioral Health
Albuquerque, New Mexico, 87131-0001
About this study
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.
Read the 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:
- 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.
- 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.
- Conditions
- Depression, Grief, PTSD, Interpersonal Relations
- Being tested
- HTUG
- Keywords
- historical trauma and unresolved grief, complicated grief, prolonged grief, interpersonal conflicts, depression, American Indians, interpersonal psychotherapy, traumatic grief, posttraumatic stress disorder
- Medical subject headings
- Depression, Stress Disorders, Post-Traumatic, Historical Trauma, Prolonged Grief Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTUGBehavioural
Also called Historical Trauma and Unresolved Grief Intervention
HTUG is a group psychotherapy...
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The PCL is a 17-item self-report measure of the 17 DSM-IV symptoms of PTSD. The PCL is used to screening individuals for PTSD, diagnosing PTSD, and monitoring symptom change during and after treatment. A total symptom severity score (range = 17-85) can be obtained by summing the scores from each of the 17 items. The PCL has good internal consistency, with a Cronbach's alpha of .86.
Measured: 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)
Historical Losses and Historical Losses Associated Symptoms Scales - The items selected for HLS were determined by a series of focus groups conducted with elders in two tribes in the upper Midwest to identify the kinds of losses associated with historical trauma and the types of emotions felt when thinking about those losses. The HLAS asks how often the respondent feels each of 12 symptoms (e.g. anger, sadness, like the loss is happening again) when they think about the losses. The scale has good internal reliability, with a Cronbach's alpha of .89.
Measured: Baseline, end of intervention (12 weeks), and 8 weeks follow up post-intervention
Changes in the Inventory of Complicated Grief (ICG)
The ICG assesses indicators of pathological grief, such as anger, disbelief, and hallucinations. It consists of 19 first-person statements concerning the immediate bereavement-related thoughts and behaviors of the client, with 5 response options ranging from "Never" to "Always." The ICG's internal consistency is good, with a Cronbach's alpha of .94. The test-retest reliability has been found to be .80. The scale has a well validated clinical cut point, with individuals scoring over 25 considered at risk for requiring clinical care.
Measured: Baseline, end of intervention (12 weeks), and 8 weeks follow up post-intervention
Inventory of Interpersonal Problems (IIP)
The IIP is a self-report measure that identifies an individual's most salient interpersonal difficulties. There are two forms: The IIP-64 contains 64 statements describing common interpersonal problems. Scales include: Domineering/ Controlling, Vindictive/Self-Centered, Cold/Distant, Socially Inhibited, Nonassertive, Overly Accommodating, Self-Sacrificing, and Intrusive/Needy. Respondents rate how distressed they have been by each problem on a scale from 0 (not at all) to 4 (extremely). The IIP scales have adequate internal consistency and test-retest reliability.
Measured: Baseline, end of intervention (12 weeks), and 8 weeks follow up post-intervention
Duke-UNC Functional Support Questionnaire
This questionnaire measures social support, which can be related to depression.
Measured: Baseline, end of intervention (12 weeks), and 8 weeks follow up post-intervention
Medication Adherence Questionnaire
this questionnaire was developed for implementation with research participants to assist in tracking the compliance with any current medication management that the participant is currently engaging in with their primary health care or behavioral health care provider. This is to see if the current medications are appropriate and helpful with depressive symptoms being experienced by the participant prior to entering into the study and during their participation in the study. This is part of Treatment as Usual to which research participants are entitled and is part of good clinical care.
Measured: baseline, two mid-points (Week 4 and 8), end of intervetion and 8 week follow up
Group Environment Scale
Developed by Moos, Insel, and Humphrey this measure is to assess group climate and comfort level of the study participants to openly discuss issues related to the target symptoms of depression in group. Clinical group facilitators/staff at each study site will complete the observational measure.
Measured: Two mid points (Weeks 4 and 8)
Group Engagement Measure
is a comprehensive measure to assess the various dimensions of group engagement by study participants. This will be completed by research team members
Measured: Two mid points (Weeks 4 and 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study start22 Apr 2013
- Primary completion24 Jan 2018
- Study completion24 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Y Brave Heart, PhD, Principal investigator, University of New Mexico Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02124694
- Sponsor's protocol ID
- 1R34MH097834-01A1
- Acronym
- HTUG-IPT
- Status last verified
- May 2016
- First submitted
- 24 Apr 2014
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iwankapiya-Healing: Historical Trauma Practice and Group IPT for American Indians
- ClinicalTrials.gov ID
- NCT02124694
- Acronym / sponsor ID
- HTUG-IPT / 1R34MH097834-01A1
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 22 Apr 2013 (actual)
- Primary completion
- 24 Jan 2018 (actual)
- Study completion
- 24 Jan 2018 (actual)
- First posted
- 28 Apr 2014 (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.
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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HTUG and IPT | Experimental | Behavioral: HTUGThis 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- Psychosis
- Personality disorder
- Bipolar disorder
- Severe vegetative depressive symptoms such as psychomotor retardation
- Acutely suicidal or homicidal individuals
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 |
|---|---|---|
| HTUGAlso: Historical Trauma and Unresolved Grief InterventionHTUG is a group psychotherapy... | Behavioural | HTUG and IPT |
Primary outcome
Changes in Hamilton Depression Scale from Baseline
Time frame: Initial Screening, two mid-points (weeks 4 and 8), end of intervention (week 12) and follow up (8 weeks post intervention)
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.
8 secondary outcomes
Changes in the PCL PTSD Checklist
Time frame: 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)
Time frame: Baseline, end of intervention (12 weeks), and 8 weeks follow up post-intervention
Changes in the Inventory of Complicated Grief (ICG)
Time frame: Baseline, end of intervention (12 weeks), and 8 weeks follow up post-intervention
Inventory of Interpersonal Problems (IIP)
Time frame: Baseline, end of intervention (12 weeks), and 8 weeks follow up post-intervention
Duke-UNC Functional Support Questionnaire
Time frame: Baseline, end of intervention (12 weeks), and 8 weeks follow up post-intervention
Medication Adherence Questionnaire
Time frame: baseline, two mid-points (Week 4 and 8), end of intervetion and 8 week follow up
Group Environment Scale
Time frame: Two mid points (Weeks 4 and 8)
Group Engagement Measure
Time frame: Two mid points (Weeks 4 and 8)
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 24 May 2022.
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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.
Maria Y Brave Heart, PhD principal investigator
University of New Mexico Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HTUG in people with Depression and Grief, run by University of New Mexico at 1 site in United States.
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 6 inclusion and 6 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 24 May 2022. 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 United States. 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.
What does the primary outcome measure?
Changes in Hamilton Depression Scale from Baseline (time frame: Initial Screening, two mid-points (weeks 4 and 8), end of intervention (week 12) and follow up (8 weeks post intervention)). It is what the study was designed to measure, not a finding.
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 24 May 2022.