Substance Use Disorder (SUD)Project CloserNCT07740395
Connecting Loved Ones to Support and Empowering Recovery
A study testing KulaMind-Recovery in people with Substance Use Disorder (SUD) and mHealth, run by Rhode Island Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorder (SUD), mHealth
- What is being tested?
- KulaMind-Recovery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
Susan Ramsey, PhD, 401-444-7831, sramsey@brownhealth.org
Evan Ames, 401-444-5040, evan.ames@brownhealth.org
About this study
Official title: Harnessing mHealth to Support Loved Ones of Individuals in Recovery From Substance Use Disorders
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.
Read the detailed description
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.
- Conditions
- Substance Use Disorder (SUD), mHealth
- Being tested
- KulaMind-Recovery
- Keywords
- Recovery, Loved Ones, Addiction, Substance Use
- Medical subject headings
- Substance-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KulaMind-RecoveryBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Individuals in Recovery | No intervention | Not described |
| Loved Ones | Experimental | Not described Receives: Behavioral: KulaMind-Recovery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline & 3-Month Follow-up
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline & 3-Month Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start17 Jul 2026
- Primary completion8 Jan 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use Disorder (SUD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Ramsey, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740395
- Sponsor's protocol ID
- 1R61DA064698-01
- Acronym
- Project Closer
- Status last verified
- Aug 2026
- First submitted
- 17 Jul 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harnessing mHealth to Support Loved Ones of Individuals in Recovery From Substance Use Disorders
- ClinicalTrials.gov ID
- NCT07740395
- Acronym / sponsor ID
- Project Closer / 1R61DA064698-01
- Conditions
- Substance Use Disorder (SUD), mHealth
- Keywords
- Recovery, Loved Ones, Addiction, Substance Use
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- 17 Jul 2026 (actual)
- Primary completion
- 8 Jan 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Individuals in Recovery | No intervention | – |
| Loved Ones | Experimental | Behavioral: KulaMind-Recovery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KulaMind-RecoveryKulaMind-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. | Behavioural | Loved Ones |
Primary outcome
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.
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.
4 secondary outcomes
Satisfaction with the Relationship measured with the Relationship Assessment Scale
Time frame: Baseline & 3-Month Follow-up
Substance use assessed with the Timeline Followback Interview
Time frame: Baseline & 3-Month Follow-up
Knowledge Regarding Substance Use Disorders and their Treatment Assessed with a 20-Item Knowledge Inventory
Time frame: Baseline & 3-Month Follow-up
Self-Efficacy to Support Recovery Measured with the Generalized Self-Efficacy Scale
Time frame: Baseline & 3-Month Follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susan Ramsey principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KulaMind-Recovery in people with Substance Use Disorder (SUD) and mHealth, run by Rhode Island Hospital at 1 site 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 12 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susan Ramsey, PhD (401-444-7831, sramsey@brownhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery Capital Score measured with the Assessment of Recovery Capital (ARC) (time frame: Baseline & 3-Month Follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2026.