DepressionNCT01958840
Evaluating Behavioral Activation Efficacy in Depressed Spanish-Speaking Latinos
A study testing Behavioral Activation for Depression Treatment and Supportive Counseling in people with Depression, run by University of Maryland, College Park at 1 site in United States.
Trial summary
Following a small, open-label pilot study that yielded very promising results of BATD, the current study will consist of a larger, randomized control trial (n=60) that will compare BATD to Supportive Counseling in outcomes of depression, contact with positive reinforcement in the environment, treatment satisfaction… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Behavioral Activation for Depression Treatment and Supportive Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Oct 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- be a minimum of 18 years of age
- be of Latino descent
- report limited English language proficiency
- meet current MDD criteria
- have completed the 4th grade or higher either in their country of origin or in the US
- not have current substance abuse or dependence
Show all 9Show fewer
- have no Bipolar or Psychotic Disorders
- not be currently receiving psychotherapy
- if currently taking antidepressants, demonstrate pharmacological stability as indicated by 3 or more consecutive months of use.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland- College Park
College Park, Maryland, 20742
About this study
Following a small, open-label pilot study that yielded very promising results of BATD, the current study will consist of a larger, randomized control trial (n=60) that will compare BATD to Supportive Counseling in outcomes of depression, contact with positive reinforcement in the environment, treatment satisfaction, therapeutic alliance, and perceived stigma. In addition, participants' adherence rates to each of the therapies and their maintenance of clinical gains at a 1-month follow-up, will be examined.
Read the detailed description
Major Depressive Disorder (MDD) is highly prevalent and widely-impairing across racial and ethnic groups. Higher rates of MDD have been observed among Latinos with limited English-language proficiency relative to the general population. Although MDD is a highly treatable condition, barriers to treatment access and delivery have been implicated in precluding this group from utilizing and receiving mental health services. Fortunately, Latinos tend to endorse positive attitudes toward psychosocial treatments for depression by applying the valued belief of "poner de su parte" or being able to do their part in one's recovery, a concept that is highly consistent with the framework of behavioral treatments for depression.
The Behavioral Activation Treatment for Depression (BATD), based on reinforcement theory, may be well-equipped to address disparities associated with higher depression prevalence rates and receipt of care among Latinos with limited English-language proficiency. Following a small, open-label pilot study that yielded very promising results of BATD, the current study will consist of a larger, randomized control trial (N = 60) that will compare BATD to Supportive Counseling in outcomes of depression, activity level, and contact with positive reinforcement in the environment.
Initial eligibility will be determined via a telephone screener, which will include questions from the Mood Disorders, Substance Use and Dependence, and Psychotic Disorders modules of the Structured Clinical Interview for DSM-IV-TR (SCID-IV; First, Spitzer, Gibbon \& Williams, 2002).
Inclusion criteria consist of the following: 1) be a minimum of 18 years of age, 2) be of Latino descent, 3) report limited English language proficiency, 4) meet current MDD criteria, 5) have completed the 4th grade or higher either in their country of origin or in the US, 6) not have current substance abuse or dependence, 7) have no Bipolar or Psychotic Disorders, and 9) not be currently receiving psychotherapy, and 10) if currently taking antidepressants, demonstrate pharmacological stability as indicated by 3 or more consecutive months of use. Excluded individuals will be referred to mental health resources within the community.
- Conditions
- Depression
- Being tested
- Behavioral Activation for Depression Treatment, Supportive Counseling
- Keywords
- Behavioral, Activation, Treatment
- Medical subject headings
- Depression, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Activation for Depression TreatmentBehavioural
Supportive CounselingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Activation Treatment for Depression | Experimental | Behavioral Activation Condition - 10 sessions Receives: Behavioral: Behavioral Activation for Depression Treatment |
| Supportive Counseling | Active comparator | Supportive Counseling Condition - 10 sessions Receives: Behavioral: Supportive Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory- II
Measured: Assessed at every session and at the 1-month follow-up
Secondary outcomes (1)
Behavioral Activation for Depression Scale
Measured: Administered at each session and at the 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startAug 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, College Park
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joe Smith, University of Maryland, College Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958840
- Sponsor's protocol ID
- 1F31MH098512-01A1
- Status last verified
- May 2023
- First submitted
- 7 Oct 2013
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Collado A, Long KE, MacPherson L, Lejuez CW. The efficacy of a behavioral activation intervention among depressed US Latinos with limited English language proficiency: study protocol for a randomized controlled trial. Trials. 2014 Jun 18;15:231. doi: 10.1186/1745-6215-15-231.
PubMed 24938081
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Behavioral Activation Efficacy in Depressed Spanish-Speaking Latinos
- ClinicalTrials.gov ID
- NCT01958840
- Acronym / sponsor ID
- 1F31MH098512-01A1
- Conditions
- Depression
- Keywords
- Behavioral, Activation, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of Maryland, College ParkUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 9 Oct 2013 (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.
Following a small, open-label pilot study that yielded very promising results of BATD, the current study will consist of a larger, randomized control trial (n=60) that will compare BATD to Supportive Counseling in outcomes of depression, contact with positive reinforcement in the environment, treatment satisfaction, therapeutic alliance, and perceived stigma. In addition, participants' adherence rates to each of the therapies and their maintenance of clinical gains at a 1-month follow-up, will be examined.
Detailed description
Major Depressive Disorder (MDD) is highly prevalent and widely-impairing across racial and ethnic groups. Higher rates of MDD have been observed among Latinos with limited English-language proficiency relative to the general population. Although MDD is a highly treatable condition, barriers to treatment access and delivery have been implicated in precluding this group from utilizing and receiving mental health services. Fortunately, Latinos tend to endorse positive attitudes toward psychosocial treatments for depression by applying the valued belief of "poner de su parte" or being able to do their part in one's recovery, a concept that is highly consistent with the framework of behavioral treatments for depression.
The Behavioral Activation Treatment for Depression (BATD), based on reinforcement theory, may be well-equipped to address disparities associated with higher depression prevalence rates and receipt of care among Latinos with limited English-language proficiency. Following a small, open-label pilot study that yielded very promising results of BATD, the current study will consist of a larger, randomized control trial (N = 60) that will compare BATD to Supportive Counseling in outcomes of depression, activity level, and contact with positive reinforcement in the environment.
Initial eligibility will be determined via a telephone screener, which will include questions from the Mood Disorders, Substance Use and Dependence, and Psychotic Disorders modules of the Structured Clinical Interview for DSM-IV-TR (SCID-IV; First, Spitzer, Gibbon \& Williams, 2002).
Inclusion criteria consist of the following: 1) be a minimum of 18 years of age, 2) be of Latino descent, 3) report limited English language proficiency, 4) meet current MDD criteria, 5) have completed the 4th grade or higher either in their country of origin or in the US, 6) not have current substance abuse or dependence, 7) have no Bipolar or Psychotic Disorders, and 9) not be currently receiving psychotherapy, and 10) if currently taking antidepressants, demonstrate pharmacological stability as indicated by 3 or more consecutive months of use. Excluded individuals will be referred to mental health resources within the community.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Activation Treatment for Depression | Experimental | Behavioral: Behavioral Activation for Depression TreatmentBehavioral Activation Condition - 10 sessions |
| Supportive Counseling | Active comparator | Behavioral: Supportive CounselingSupportive Counseling Condition - 10 sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- be a minimum of 18 years of age
- be of Latino descent
- report limited English language proficiency
- meet current MDD criteria
- have completed the 4th grade or higher either in their country of origin or in the US
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Behavioral Activation for Depression Treatment | Behavioural | Behavioral Activation Treatment for Depression |
| Supportive Counseling | Behavioural | Supportive Counseling |
Primary outcome
Beck Depression Inventory- II
Time frame: Assessed at every session and at the 1-month follow-up
1 secondary outcome
Behavioral Activation for Depression Scale
Time frame: Administered at each session and at the 1-month follow-up
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 30 May 2023.
- Derived from this study: PubMed 24938081Collado A, Long KE, MacPherson L, Lejuez CW. The efficacy of a behavioral activation intervention among depressed US Latinos with limited English language proficiency: study protocol for a randomized controlled trial. Trials. 2014 Jun 18;15:231. doi: 10.1186/1745-6215-15-231.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation for Depression Treatment and Supportive Counseling in people with Depression, run by University of Maryland, College Park 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 9 inclusion and 0 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 30 May 2023. 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?
Beck Depression Inventory- II (time frame: Assessed at every session and at the 1-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01958840, which also lists 1 linked publication.
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 30 May 2023.