Condition category
Mental and Behavioural Disorders
Date applied
02/04/2019
Date assigned
03/04/2019
Last edited
05/04/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Many factors influence whether or not someone seeks help for depression. The purpose of this study is to understand how African American students’ willingness to seek help for depression can change.

Who can participate?
People who identify as Black or African American, are between the ages of 18-25 and have never been diagnosed with or received treatment for mental illness are welcome to participate.

What does the study involve?
If you agree to participate in this study, you will be asked to complete the anonymous pre-test and post-test surveys and actively participate in a course about depression. The course will provide you with information about depression and how you feel about people who may be affected. You will be asked to work in groups to discuss various issues, view videos about depression and share your opinions with others during a discussion. This course will take about 2 hours and 30 minutes. You will also have an opportunity to voluntarily participate in an anonymous 3-month follow-up survey that will take approximately 15 minutes to complete. This study will include approximately 114 participants.

What are the possible benefits and risks of participating?
There are no foreseeable risks to participating in this study. All responses are anonymous, and we will not ask for identifiable information. Therefore, the survey cannot be linked to you. You will receive no direct benefit from participating in this study; however, your participation in this study will add to the general knowledge of depression help-seeking among African American college students.

Where is the study run from?
This study is run from the University of Texas at Austin.

When is the study starting and how long is it expected to run for?
The study is expected to run from November 2016 to April 2017.

Who is funding the study?
This study is funded by the Hogg Foundation for Mental Health.

Who is the main contact?
Benita Bamgbade
benitabam@gmail.com

Trial website

N/A

Contact information

Type

Public

Primary contact

Dr Benita Bamgbade

ORCID ID

http://orcid.org/0000-0003-1645-5838

Contact details

140 The Fenway
Room R218X
360 Huntington Avenue
Boston
02115
United States of America
6173737973
b.bamgbade@northeastern.edu

Additional identifiers

EudraCT number

N/A

ClinicalTrials.gov number

N/A

Protocol/serial number

HU3732007

Study information

Scientific title

An intervention to improve willingness to seek help for depression among African American young adults: a non-randomised study

Acronym

N/A

Study hypothesis

1. Willingness to seek help will significantly increase from pre to immediate post-test.
1.1. Attitude toward seeking help will significantly increase (more favourable attitude) from pre to immediate post-test.
1.2. Perceived behavioural control will significantly increase from pre to immediate post-test.
1.3. Mental illness (MI) stigma will significantly decrease from pre to immediate post-test.
2. MI Stigma and Cultural variables (medical mistrust, self-reliance and religiosity) will significantly increase the predictive power of the regression model compared to a model that utilizes only the TPB constructs (attitude, subjective norm, perceived behavioural control and covariates [gender identity, depression knowledge and MI personal experience]) to predict willingness to seek help.

Ethics approval

Approved 11/11/2016, the University of Texas Institutional Review Board (The University of Texas at Austin, Office of Research Support and Compliance, Peter T. Flawn Academic Center, Suite 426, 2304 Whitis Ave, Austin, TX 78712; 512-471-8871), ref: 2016-10-0111.

Study design

Prospective one group intervention, non-randomised design with three month follow up

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Schools

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participation information sheet

Condition

Depression

Intervention

The intervention consisted of three sections. Section 1 was led by the primary researcher, who is also a licensed pharmacist. This section consisted of the introduction, an opening activity, an active learning activity (fact or fiction), a depression overview, and another active learning activity (peanut butter in the jar)

Section 2, led by a licensed AA psychologist (from the university health centre and also the liaison to Black & African-American students in the counselling and mental health centre), focused on stigma and the unique cultural variables that impact AA help-seeking (identified in the Information Gathering stage). This section also featured a video clip of a young AA celebrity athlete discussing his personal experience with MI and his journey to recovery, a group discussion and a psychotherapy question and answer session.

The last section, section 3, was dedicated to a young AA college student consumer educator who shared his lived experience with schizophrenia and depression. This presentation was followed by a question and answer session where students had the opportunity to interact with the consumer educator. The study intervention was designed as a 2 hour and 30 min course in efforts to maintain participant engagement and avoid participant fatigue.

The follow-up survey consisted of a survey (identical to the post-test survey) with additional questions assessing actual help-seeking behaviour.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Willingness to seek help for depression is measured using a self-administered anonymous survey at baseline, immediately following the intervention (post-test) and at the 3-month follow up. All survey items were created by the researchers of this study using previous focus groups and the Theory of Planned Behaviour as a guiding framework:
2. Actual behaviour is measured at the 3-month follow-up.

Secondary outcome measures

The following variables are collected using self-administered anonymous surveys at baseline, immediately following the intervention (post-test) and at the 3-month follow up. All survey items were created by the researchers of this study using previous focus groups and the Theory of Planned Behaviour as a guiding framework:
1. Attitude
2. Perceived behavioural control
3. Stigma

Overall trial start date

16/04/2016

Overall trial end date

30/09/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Identify as Black or African American
2. 18-25 years old
3. Never been diagnosed with and/or received treatment for a mental health condition

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

114

Participant exclusion criteria

N/A

Recruitment start date

20/08/2016

Recruitment end date

16/11/2016

Locations

Countries of recruitment

United States of America

Trial participating centre

University of Texas at Austin
110 Inner Campus Drive Austin, TX 78705
Austin
78705
United States of America

Sponsor information

Organisation

The University of Texas at Austin

Sponsor details

110 Inner Campus Drive
Austin
TX 78705
Austin
78705
United States of America
512-471-3434
orsc@uts.cc.utexas.edu

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Hogg Foundation for Mental Health

Alternative name(s)

Hogg Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both publically funded and privately funded)

Location

United States of America

Results and Publications

Publication and dissemination plan

Results from this study will be submitted to peer-review journals via 2 manuscripts in 2019.

IPD sharing statement: the datasets generated during and/or analysed during the current study are not expected to be made available due to requirements designated by the University of Texas at Austin Institutional Review Board.

Intention to publish date

31/12/2019

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/04/2019: Internal review. 03/04/2019: Trial's existence confirmed by the University of Texas Institutional Review Board.