An interventional study of KulaMind-Recovery in Substance Use Disorder (SUD) and mHealth, sponsored by Rhode Island Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Rhode Island Hospital · Not applicable, Interventional, and Other
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.
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.
2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.
This study's planned enrollment of 60 is below the median of 108 across 1,840 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →Rhode Island Hospital is the lead sponsor of 191 studies on the registry; 36 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for Individuals in Recovery:
Inclusion Criteria for Loved Ones:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: KulaMind-Recovery
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.
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.
Time frame: 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.
Time frame: Baseline & 3-Month Follow-up
Satisfaction with the Relationship measured with the Relationship Assessment Scale
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.
Time frame: Baseline & 3-Month Follow-up
Substance use assessed with the Timeline Followback Interview
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.
Time frame: Baseline & 3-Month Follow-up
Knowledge Regarding Substance Use Disorders and their Treatment Assessed with a 20-Item Knowledge Inventory
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.
Time frame: Baseline & 3-Month Follow-up
Self-Efficacy to Support Recovery Measured with the Generalized Self-Efficacy Scale
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.
Time frame: Baseline & 3-Month Follow-up
Demographic Information Measured with the PhenX toolkit
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
Time frame: Baseline
Treatment Services Received measured with the Treatment Services Review
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
Time frame: Baseline & 3-Month Follow-up
Perceived Quality of Life Measured with the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form
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
Time frame: Baseline & 3-Month Follow-up
Wellbeing measured by the World Health Organization-Five Well-Being Index
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
Time frame: Baseline & 3-Month Follow-up
Depressive Symptoms measured with the Patient Health Questionnaire-2
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
Time frame: Baseline & 3-Month Follow-up
Anxiety Symptoms measured with the Generalized Anxiety Disorder-2
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.
Time frame: Baseline & 3-Month Follow-up
Perceived Stress measured with the Perceived Stress Scale
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
Time frame: Baseline & 3-Month Follow-up
Perceived Social Support measured with the Multidimensional Scale of Perceived Social Support
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.
Time frame: Baseline & 3-Month Follow-up
Lifetime Substance Use Disorder Symptoms measured with Substance Use Symptom Checklist
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.
Time frame: Baseline
Perceived Utility and Impact of the Intervention measured with Utility and Impact Questionnaire
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.
Time frame: 3-Month Follow-up
Satisfaction with the Intervention measured with the Client Satisfaction Questionnaire
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.
Time frame: 3-Month Follow-up
Plan to share: No
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