Connecting Loved Ones to Support and Empowering Recovery

NCT07740395 | Recruiting DMC

• 1 other identifier: 1R61DA064698-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Substance use disorders are highly prevalent. However, recovery from them is possible. The recovery process can benefit greatly from support from loved ones. Loved ones may need guidance in the most helpful ways to support recovery. This study aims to refine and test a web-based intervention, known as KulaMind-Recovery, which offers online skill building and educational modules, one-on-one video sessions and "on-demand" text-based support from a coach, and access to a community forum to connect with others with shared experience.

Conditions

Substance Use Disorder (SUD); mHealth

Keywords

Recovery; Loved Ones; Addiction; Substance Use

Outcome Measures

Primary Outcomes (2)

• Recovery Capital Score measured with the Assessment of Recovery Capital (ARC)

  Recovery capital represents the total collection of resources that an individual possesses which can facilitate addiction recovery. The Assessment of Recovery (ARC) is a psychometrically validated measure of recovery capital, which produces a recovery capital score ranging from 0 to 50. Higher scores represent greater recovery capital. This is the primary outcome of individuals in recovery.

  Baseline & 3-Month Follow-up

• Substance Use Disorder-Related Stigma measured by the Stigma of Drug Users Scale

  The Stigma of Drug Users Scale will be used to assess Substance Use Disorder-Related Stigma. The Stigma of Drug Users Scale has good internal reliability across different drug classes. Higher scores represent greater substance use disorder-related stigma. This is primary outcome for loved ones.

  Baseline & 3-Month Follow-up

Secondary Outcomes (4)

• Satisfaction with the Relationship measured with the Relationship Assessment Scale

  Baseline & 3-Month Follow-up

• Substance use assessed with the Timeline Followback Interview

  Baseline & 3-Month Follow-up

• Knowledge Regarding Substance Use Disorders and their Treatment Assessed with a 20-Item Knowledge Inventory

  Baseline & 3-Month Follow-up

• Self-Efficacy to Support Recovery Measured with the Generalized Self-Efficacy Scale

  Baseline & 3-Month Follow-up

Other Outcomes (11)

• Demographic Information Measured with the PhenX toolkit

  Baseline

• Treatment Services Received measured with the Treatment Services Review

  Baseline & 3-Month Follow-up

• Perceived Quality of Life Measured with the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form

  Baseline & 3-Month Follow-up

Study Arms (2)

Individuals in Recovery

NO INTERVENTION

Loved Ones

EXPERIMENTAL

Behavioral: KulaMind-Recovery

Interventions

KulaMind-Recovery BEHAVIORAL

KulaMind-Recovery (KM-R) is an AI-powered web-based support platform that provides psychoeducation and training in evidenced-based cognitive behavioral skills and family interventions for substance use disorder. Loved ones will be matched with a human coach who will create a custom program of skills, psychoeducation materials, and other interventions. The coach will deliver these assignments through the AI digital tools on the KM-R platform, so loved ones can learn or practice skills at their convenience. For emotional support, accountability, and trouble shooting, coaches provide group video sessions each week. Each loved one will have access to text-based support form their coach, which allows the coach to support skill-building and troubleshooting in real time. Loved ones will also have access to a community forum, hosted on the platform, where they can connect with other loved ones with shared experiences. The community forum is monitored by a trained, live moderator.

Loved Ones

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• have met criteria for a substance use disorder (with or without concomitant alcohol use disorder) in the past 24 months
• have taken steps in the past 12 months to quit using drugs, cut down on drug use, or change the way in which they use drugs in order to improve the quality of their lives
• willing to nominate a loved one to receive KulaMind-Recovery
• have a loved one who is willing to participate in the study
• able to understand and speak English and provide written and verbal consent
• have a sustained relationship with the individual in recovery and are perceived to be an important person in the individual in recovery's life
• do not provide professional substance use disorder-related services to the individual in recovery
• have regular access to a device to engaged with KulaMind-Recovery
• able to understand and speak English and provide written and verbal informed consent
• do not endorse current (past month) suicidality

Sponsors & Collaborators

• Rhode Island Hospital: lead

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders; Behavior, Addictive

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Study Officials

• Susan Ramsey

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Ramsey, PhD

CONTACT

401-444-7831; sramsey@brownhealth.org

Evan Ames

CONTACT

401-444-5040; evan.ames@brownhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an open-label pilot trial. Loved ones that enroll all receive access to the KulaMind-Recovery intervention for 12 weeks. Individuals in recovery do not receive intervention.

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 31, 2026
• Study Start: July 17, 2026
• Primary Completion (Estimated): January 8, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)