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NCT Number: NCT07740395

Connecting Loved Ones to Support and Empowering Recovery

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.

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Key information

Conditions

Substance Use Disorder (SUD) Behavior Behavior, Addictive Chemically-Induced Disorders Compulsive Behavior Impulsive Behavior Mental Disorders Substance-Related Disorders mHealth

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Substance use disorders (SUDs) are one of the most prevalent chronic behavioral health issues in the United States and are responsible for significant morbidity and mortality. However, there is a high rate of recovery from SUDs. The loved ones of those in recovery can be an important source of support. Unfortunately, relationships are often strained by the chronic relapsing and remitting nature of SUDs, and SUD-related stigma may impede support from loved ones. Efforts to implement evidence-based interventions for loved ones have been hampered by a number of factors, including required specialized training for interventionists and the lengthy nature of the interventions. Efficacious and scalable interventions are therefore needed to guide the loved ones of those in recovery in evidence-based approaches to support the recovery process. mHealth facilitated interventions could be used to address these barriers, allowing for more efficient use of interventionist time through automation while maintaining "on demand" availability and the human touch that many find helpful. The goal of this project is to refine the KulaMind-Recovery Platform (KM-R), which is an AI-powered online program that aims to improve healthy family/social network behaviors and self- regulation skills of loved ones of those in recovery to strengthen the social support network. In addition to online skill building and educational modules, each loved one is matched with a coach who provides emotional support, accountability, and troubleshooting via group-based video sessions and "on demand" text-based support. Lastly, KM-R includes access to a community forum that allows loved ones to connect with others with shared experience. To accomplish our goal of refining this intervention, we will conduct an open label pilot study with 30 dyads (individual in early recovery and a loved one), in which the loved ones receive access to KM-R for 3 months, to examine the feasibility, acceptability, and preliminary signs of efficacy of the intervention.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Individuals in Recovery:

  • 18+
  • 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

Inclusion criteria

for Loved Ones:

  • 18+
  • 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

Treatment and study plan

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.

Primary outcomes

  1. Recovery Capital Score measured with the Assessment of Recovery Capital (ARC)

    Time frame: Baseline & 3-Month Follow-up

    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.

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

    Time frame: Baseline & 3-Month Follow-up

    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.

Secondary outcomes

  1. Satisfaction with the Relationship measured with the Relationship Assessment Scale

    Time frame: Baseline & 3-Month Follow-up

    The Relationship Assessment Scale will be used to assess satisfaction with the relationship from the perspective of both the individual in recovery and the loved one. Higher scores represent greater relationship satisfaction. This is a secondary outcome for both individuals in recovery and loved ones.

  2. Substance use assessed with the Timeline Followback Interview

    Time frame: Baseline & 3-Month Follow-up

    The Timeline Followback Interview will be used to assess daily alcohol and drug use. The number of standard drinks consumed and the classes of drugs used each day will be assessed. This is a secondary outcome for individuals in recovery.

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

    Time frame: Baseline & 3-Month Follow-up

    To assess knowledge regarding substance use disorder, a 20-item knowledge test consisting of true/false statements will be administered to loved ones. A higher score represents greater substance use disorder knowledge. This is a secondary outcome for loved ones.

  4. Self-Efficacy to Support Recovery Measured with the Generalized Self-Efficacy Scale

    Time frame: Baseline & 3-Month Follow-up

    Self-Efficacy to Support Recovery will be assessed with a modified version of the Generalized Self-Efficacy Scale tailored to measure self-efficacy regarding skills addressed in KulaMind-Recovery. Higher scores represent greater self-efficacy to support recovery. This is a secondary outcome for loved ones.

Other outcomes

  1. Demographic Information Measured with the PhenX toolkit

    Time frame: Baseline

    Basic demographic information including age, sex, race, ethnicity, and marital status will be collected to characterize our sample of participants. This is an Other Outcome for individuals in recovery and loved ones

  2. Treatment Services Received measured with the Treatment Services Review

    Time frame: Baseline & 3-Month Follow-up

    The Treatment Services Review will be used to assess receipt of case management, psychiatric, mutual support, peer recovery coaching, and other treatment services. This is an Other Outcome for individuals in recovery and loved ones

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

    Time frame: Baseline & 3-Month Follow-up

    Overall quality of life for individuals in recovery and loved ones will be assessed using the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form. Higher scores represent greater perceived quality of life. This is an Other Outcome for individuals in recovery and loved ones

  4. Wellbeing measured by the World Health Organization-Five Well-Being Index

    Time frame: Baseline & 3-Month Follow-up

    The World Health Organization-Five Well-Being Index will be administered to individuals in recovery and loved ones to assess wellbeing. Higher scores represent greater wellbeing. This is an Other Outcome for individuals in recovery and loved ones

  5. Depressive Symptoms measured with the Patient Health Questionnaire-2

    Time frame: Baseline & 3-Month Follow-up

    The Patient Health Questionnaire-2 will be used to assess depressive symptoms. Higher scores represent greater depressive symptoms. This is an Other Outcome for individuals in recovery and loved ones

  6. Anxiety Symptoms measured with the Generalized Anxiety Disorder-2

    Time frame: Baseline & 3-Month Follow-up

    Anxiety symptoms will be assessed with the Generalized Anxiety Disorder-2 questionnaire. Higher scores represent greater anxiety symptoms. This is an Other Outcome for individuals in recovery and loved ones.

  7. Perceived Stress measured with the Perceived Stress Scale

    Time frame: Baseline & 3-Month Follow-up

    The Perceived Stress Scale will be used to assess perceived stress among participants. Higher scores represent greater levels of perceived stress. This is an Other Outcome for individuals in recovery and loved ones

  8. Perceived Social Support measured with the Multidimensional Scale of Perceived Social Support

    Time frame: Baseline & 3-Month Follow-up

    The Multidimensional Scale of Perceived Social Support will be used to assess perceived social support among participants. Higher scores represent greater levels of perceived social support. This is an Other Outcome for individuals in recovery and loved ones.

  9. Lifetime Substance Use Disorder Symptoms measured with Substance Use Symptom Checklist

    Time frame: Baseline

    The Substance Use Symptom Checklist will be used to assess the prevalence of substance use disorder symptoms within loved ones' lifetimes. This is an Other Outcome for loved ones.

  10. Perceived Utility and Impact of the Intervention measured with Utility and Impact Questionnaire

    Time frame: 3-Month Follow-up

    The Utility and Impact Questionnaire will be used to assess the perceived utility and impact of the KulaMind-Recovery intervention. Higher scores represent greater perceived utility and impact of the intervention. This is an Other Outcome for loved ones.

  11. Satisfaction with the Intervention measured with the Client Satisfaction Questionnaire

    Time frame: 3-Month Follow-up

    The Client Satisfaction Questionnaire will be used to assess satisfaction with the KulaMind-Recovery intervention. Higher scores represent greater satisfaction with the intervention. This is an Other Outcome for loved ones.

Study contacts

Contact information is provided by the study sponsor or research team.

Evan Ames

CONTACT

[email protected]

401-444-5040

Susan Ramsey, PhD

CONTACT

[email protected]

401-444-7831

Sponsors and collaborators

Lead sponsor

Rhode Island Hospital

Other

Registry information

Official study title

Harnessing mHealth to Support Loved Ones of Individuals in Recovery From Substance Use Disorders

Acronym: Project Closer

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 31, 2026
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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