Connecting Loved Ones to Support and Empowering Recovery

ConditionsSubstance Use Disorder (SUD)mHealth

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorRhode Island Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Individuals in RecoveryNo intervention 0 interventions

Group B: Loved OnesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Other outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rhode Island Hospital

Lead sponsor

Source ClinicalTrials.gov

Apply now