Technology Enhanced Behavioral Activation Treatment for Substance Use

NCT02707887 | Completed

• 2 other identifiers: 15-0815R01DA026424
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to:

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

Conditions

Substance-Related Disorders; Depressive Disorder; Behavioral Symptoms; Risk-Taking; Sexual Behavior

Keywords

Mental Disorders; Mood Disorders; Behavioral Activation

Outcome Measures

Primary Outcomes (1)

• Timeline Followback (TLFB)

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

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

Secondary Outcomes (8)

• Behavioral Activation for Depression Scale (BADS)

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

• Reward Probability Index (RPI)

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

• Beck Depression Inventory-II (BDI-II)

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

• Daily Goals Form

  Baseline to a 3-months post treatment.

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

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

Study Arms (3)

Treatment as Usual

PLACEBO COMPARATOR

Patients are offered substance use group therapy including relapse prevention. They are also provided medical consultation on an ongoing basis as needed.

Behavioral: Treatment as Usual

LETS ACT

ACTIVE COMPARATOR

The 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.

Behavioral: LETS ACT; Behavioral: Treatment as Usual

LETS ACT-SE

ACTIVE COMPARATOR

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.

Behavioral: LETS ACT-SE; Behavioral: Treatment as Usual

Interventions

LETS ACT BEHAVIORAL

The Life Enhancement Treatment for Substance Use (LETS ACT)

Also known as: Behavioral Activation, Life Enhancement Treatment for Substance Use

LETS ACT

LETS ACT-SE BEHAVIORAL

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.

Also known as: Behavioral Activation, Smartphone-Enhanced LETS ACT

LETS ACT-SE

Treatment as Usual BEHAVIORAL

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

Also known as: TAU

LETS ACT; LETS ACT-SE; Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-3270, United States

Location

Southlight Healthcare

Raleigh, North Carolina, 27604, United States

Location

Related Publications (2)

• 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.

  PMID: 39786834 DERIVED

• 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.

  PMID: 34730535 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; Depressive Disorder; Behavioral Symptoms; Risk-Taking; Sexual Behavior; Mental Disorders; Mood Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Behavior

Study Officials

• Stacey Daughters, Ph.D.

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: March 14, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 16, 2023

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)