NCT06296030

Culturally Tailored ACT for Black Trauma

Withdrawn NA Last updated 6 March 2024

What this trial tests

NA trial testing POOF ACT program in Stress Disorders, Traumatic. Withdrawn.

Timeline

1 September 2021

Primary endpoint
1 September 2022

31 August 2023

Quick facts

Lead sponsor	Azusa Pacific University
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	double
Primary purpose	treatment
Start date	1 September 2021
Primary completion	1 September 2022
Estimated completion	31 August 2023
Sites	1 location across United States

Drugs / interventions tested

• POOF ACT program
• Classic ACT program

Conditions studied

• Stress Disorders, Traumatic — all drugs for Stress Disorders, Traumatic →
• Anxiety — all drugs for Anxiety →
• Anxiety Disorders — all drugs for Anxiety Disorders →

Sponsor

Azusa Pacific University

Who can join

Adults 18 to 65, any sex, with Stress Disorders, Traumatic or Anxiety. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Blacks in America more frequently meet the criteria for posttraumatic stress disorder (PTSD) than any other US race or ethnicity. Yet, blacks are among the groups least likely to use mental health services for trauma. Thus, a large number of traumatized blacks suffer silently and remain untreated.

Acceptance and Commitment Therapy (ACT) is an empirically-based psychological intervention that uses acceptance and mindfulness strategies, with commitment and behavior change strategies, to increase psychological flexibility and decrease anxiety outcomes. While culturally tailored mental health interventions have been shown useful for racial and ethnic minorities, there have been few efforts to tailor ACT for blacks. This NIH R21 would compare an ACT model specifically culturally tailored for blacks (POOF) to the classic ACT model in a randomized trial, where clinicians will conduct 12-session telehealth synchronous virtual groups. Eighty black participants who self-identify as suffering from stress or anxiety will be confidentially recruited. Two specific aims are proposed:

Aim 1) It is expected that POOF participants will report higher levels of acceptability of treatment than classic ACT participants and that POOF participants will have better adherence to treatment regimens than traditional ACT participants.

Aim 2) Given that race-based stress may mediate anxiety symptoms in U.S. based blacks, it is expected that POOF will decrease race-based stress, thereby mattering the most for improving anxiety outcomes for blacks.

The proposed R21 pilot study will be the first randomized controlled trial to evaluate an ACT intervention tailored explicitly for black racial trauma. This study will provide critical data needed to plan and design a future R01 controlled longitudinal effectiveness study. The long-term objective is to significantly reduce the prevalence of stress and anxiety-related symptoms due to traumatic events for Blacks by increasing treatment acceptability for this population. Since blacks have the highest rates of trauma prevalence and chronicity, yet they are still underrepresented in mental health treatment, this tailored intervention can have a significant public health impact.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.