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Substance-Related DisordersNCT02707887

Technology Enhanced Behavioral Activation Treatment for Substance Use

A study testing LETS ACT, LETS ACT-SE and Treatment as Usual in people with Substance-Related Disorders and Depressive Disorder, run by University of North Carolina, Chapel Hill at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to: 1. test the effect of a smartphone enhanced LETS ACT (LETS ACT-SE) on frequency of substance use 2. use functional magnetic resonance imaging (fMRI) to test the relationship between neuromarkers of reward sensitivity on frequency of substance use. Read more about this study

Who is it for?
Ages 18 to 55 years
What is being tested?
LETS ACT, LETS ACT-SE and Treatment as Usual
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
206 participants
Where
2 sitesUnited States
Study dates
Jan 2016to Dec 2020
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 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Between 18 and 55
  • Meet criteria for DSM-V substance use disorder
  • Elevated depressive symptoms (BDI ≥ 14)

Who cannot join

  • Limited mental competency (MMSE < 23)
  • Psychosis
  • The use of psychotropic medication for < 3 months
  • The inability to give informed, voluntary, written consent to participate

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599-3270

  • Southlight Healthcare

    Raleigh, North Carolina, 27604

Other trials in United States

About this study

The purpose of this study is to:

  1. test the effect of a smartphone enhanced LETS ACT (LETS ACT-SE) on frequency of substance use
  2. use functional magnetic resonance imaging (fMRI) to test the relationship between neuromarkers of reward sensitivity on frequency of substance use.
Read the detailed description

Comorbid substance use disorder (SUD) and depression is highly prevalent and associated with elevated rates of post treatment relapse to substance use, HIV risk behavior, and associated poor mental and physical health outcomes. Further, rates of substance use and depression disproportionately affect minority groups and those living in poverty. Although efficacious, the often complex, specialized nature of CBT poses problems in its integration into substance use treatment programs. Budget cuts for mental health and substance use treatment both nationally and in the state of North Carolina, reduce availability of publically funded treatment programs and staff to patient ratios. To address this limitation, a behavioral activation (BA) treatment, the Life Enhancement Treatment for Substance Use (LETS ACT), was developed to treat depressive symptoms among a predominantly African American sample of low income illicit drug users currently receiving residential substance use treatment. Collectively, two Stage I studies and 1 year follow-up data from the investigators Stage II R01DA026424 indicate that compared to a control condition, LETS ACT is associated with significantly better outcomes for treatment retention, post treatment abstinence, HIV sexual risk behavior, depressive symptoms, and environmental reward.

Although these strong outcomes suggest that LETS ACT may be ready for a Stage III dissemination trial, it is of note that there was a significant indirect effect of LETS ACT homework compliance on post treatment substance use and HIV sexual risk behavior via the theoretically proposed BA mechanism of action, environmental reward. In the context of limited access to care, these findings point to the need to identify cost-effective delivery-vehicles to increase treatment engagement outside of clinician sessions. Further, identifying neuroscience based biomarkers (neuromarkers) underlying key theoretical aspects of BA (i.e., reward sensitivity), and their relation to heterogeneity in BA treatment response among substance users with depression, are critical for the identification of accurately targeted interventions.

Being tested
LETS ACT, LETS ACT-SE, Treatment as Usual
Keywords
Mental Disorders, Mood Disorders, Behavioral Activation
Medical subject headings
Substance-Related Disorders, Depressive Disorder, Behavioral Symptoms, Risk-Taking, Sexual Behavior, Mental Disorders, Mood Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LETS ACTBehavioural

    Also called Behavioral Activation, Life Enhancement Treatment for Substance Use

    The Life Enhancement Treatment for Substance Use (LETS ACT)

  • LETS ACT-SEBehavioural

    Also called Behavioral Activation, Smartphone-Enhanced LETS ACT

    Participants assigned to the smartphone-enhanced LETS ACT (LETS ACT-SE) condition will be provided the exact same treatment as outlined in LETS ACT, except that LETS ACT-SE participants will record their daily goals using smartphone technology.

  • Treatment as UsualBehavioural

    Also called TAU

    Participants will receive the treatment typically provided to patients at the substance use treatment facility.

Study groups in NCT02707887
Study groupRoleWhat they receive
Treatment as UsualPlacebo comparatorPatients are offered substance use group therapy including relapse prevention. They are also provided medical consultation on an ongoing basis as needed.
Receives: Behavioral: Treatment as Usual
LETS ACTActive comparatorThe Life Enhancement Treatment for Substance Use (LETS ACT) involves the discussion of the treatment rationale, identification of values and goals in various life areas and activities in line with chosen life areas, and training for patients to identify their cycle of negative mood and behavior using forms to track their daily goals.
Receives: Behavioral: LETS ACT; Behavioral: Treatment as Usual
LETS ACT-SEActive comparatorParticipants assigned to the smartphone-enhanced LETS ACT (LETS ACT-SE) condition will be provided the exact same treatment as outlined in LETS ACT, except that LETS ACT-SE participants will record their daily goals using smartphone technology.
Receives: Behavioral: LETS ACT-SE; Behavioral: Treatment as Usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Timeline Followback (TLFB)

    The Time Line Follow Back is a self-report measure of drug and alcohol use.

    Measured: TLFB will be assessed from baseline to a 12-month follow up period.

Secondary outcomes (8)

  1. Behavioral Activation for Depression Scale (BADS)

    The BADS is a 25-item self-report measure of overall level of activity involvement

    Measured: BADS will be assessed from baseline to a 12-month follow up period.

  2. Reward Probability Index (RPI)

    The RPI is a 20-item self-report measure used to assess environmental reward and punishment.

    Measured: RPI will be assessed from baseline to a 12-month follow up period.

  3. Beck Depression Inventory-II (BDI-II)

    The Beck Depression Inventory is a 21-item self-report measure of depressive symptoms

    Measured: BDI-II will be evaluated from baseline to a 12-month follow up period

  4. Daily Goals Form

    The Daily Goals Form is used to measure Treatment Engagement.

    Measured: Baseline to a 3-months post treatment.

  5. Texas Christian University (TCU) HIV/AIDS Risk Assessment Form

    The TCU is a self-structured interview that measures HIV risk behavior in the domains of drug use and sex

    Measured: TCU will be assessed from baseline to a 12-month follow up period.

  6. Urinalysis

    Urinalysis is a biological measure of substance use.

    Measured: Urinalysis is assessed from post treatment to a 12-month follow up period

  7. Breathalyzer

    Breathalyzer is a biological measure of alcohol use.

    Measured: Breathalyzer will be assessed from baseline to a 12-month follow up period.

  8. Short Form Health Survey (SF-12)

    The SF-12 is a 12-item self-report measure of mental and physical health-related functioning.

    Measured: SF-12 will be assessed from baseline to a 12-month follow up period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionDec 2020
  4. Study completionDec 2020

Resources

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
Single blind
Who is masked
Participant
Enrolment
206 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02707887
Sponsor's protocol ID
15-0815
Other IDs
R01DA026424
Status last verified
Jan 2021
First submitted
27 May 2015
Last updated
16 Oct 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Kane L, Reese ED, Paquette C, Paladino M, Linares Abrego P, Daughters SB. Substance use negatively impacts change in reinforcement during the year following substance use treatment. Psychol Addict Behav. 2025 May;39(3):238-253. doi: 10.1037/adb0001051. Epub 2025 Jan 9.

    PubMed 39786834

  • Paquette CE, Rubalcava DT, Chen Y, Anand D, Daughters SB. A Mobile App to Enhance Behavioral Activation Treatment for Substance Use Disorder: App Design, Use, and Integration Into Treatment in the Context of a Randomized Controlled Trial. JMIR Form Res. 2021 Nov 3;5(11):e25749. doi: 10.2196/25749.

    PubMed 34730535

Questions about this trial

What is this clinical trial studying?

A study testing LETS ACT, LETS ACT-SE and Treatment as Usual in people with Substance-Related Disorders and Depressive Disorder, run by University of North Carolina, Chapel Hill at 2 sites 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 3 inclusion and 4 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 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?

Timeline Followback (TLFB) (time frame: TLFB will be assessed from baseline to a 12-month follow up period.). 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 NCT02707887, which also lists 2 linked publications.

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 16 Oct 2023.

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