Alcohol Use DisorderCIRCLENCT05326438
mHealth App for Changing Alcohol Use in Alaska Native American Indian People
A study testing CIRCLE mHealth app in people with Alcohol Use Disorder, run by Southcentral Foundation at 1 site in United States.
Trial summary
For many people who have trouble with alcohol, peer support - the opportunity to share challenges, problem-solving strategies, and successes with supportive others - can be helpful. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- CIRCLE mHealth app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2022to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Alaska Native/American Indian;
- ≥ 21 years of age;
- Having a desire to change drinking behavior;
- Receiving services at Southcentral Foundation and reside in the Anchorage Service Unit (urban and rural);
- English-speaking;
- Having access to a smartphone or tablet.
Who cannot join
- Not Alaska Native/American Indian;
- Non-English speaking;
- Having a medical or severe psychiatric condition that the PIs determine would make it difficult for the individual to use the app or participate in the interview;
- Not having access to a smartphone or tablet (e.g., iPad, Kindle Fire, etc.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cultural Innovations for Recovery in Community-Based Learning Environments (CIRCLE) Phase 3: Testing an Online Learning Community Application
For many people who have trouble with alcohol, peer support - the opportunity to share challenges, problem-solving strategies, and successes with supportive others - can be helpful. Building on Southcentral Foundation's (SCF's) established learning circles for sobriety support, the goal of this study is to culturally adapt and test the acceptability and feasibility of a smartphone app for sobriety support among Alaska Native and American Indian (AN/AI) people. In Aims 1 and 2 of this study, the investigators used input from patients and providers to culturally adapt a commercially available mHealth app for AN/AI people dealing with alcohol misuse. The investigators then merged culturally relevant content (e.g., stories and music) and skill-building modules based on the Community Reinforcement Approach with the existing informational and peer support features of the Connections app, a product of CHESS Health accessible on smartphones and tablets. The investigators will work with up to 125 SCF patients to assess the acceptability, feasibility, and measurable effects of the culturally-adapted app among AN/AI adults 21 and older, relying on questionnaires and interviews to evaluate the app features and utility.
The study's primary outcome is the feasibility and acceptability of the modified CHESS app for AN/AI people as a tool for sobriety. The secondary outcomes are to examine changes in quality of life, alcohol use and problems, self-efficacy in sobriety, and stages of change over the course of using the app. The investigators will also explore whether alcohol use and problems are mediated by frequency of app use, app satisfaction, and alcohol self-efficacy.
Read the detailed description
Southcentral Foundation (SCF) has a long history of stakeholder engagement, recognizing that engaged patients seek out information, work collaboratively with providers, and are more likely to demonstrate healthy choices and disease-specific self-management behaviors. SCF has used qualitative methods to identify and meet the changing needs of patients. Building on work in Aim 1 and Aim 2, which provided patient feedback about both the Connections app and the intended measurement tools, work in this Aim will include testing a modified version of the app with SCF patients.
The Connections app supports individuals in recovery by reducing relapse and promoting prosocial engagement. The app allows people to track their sobriety, learn new recovery skills, track treatment plans, set reminders, journal about their recovery, and discover helpful videos and testimonials through an extensive resource library. The app also has a "recovery help button" that can be pressed whenever the participant needs urgent help. Examples of Connections content include motivational talks, meditations, addiction recovery speakers, stress management, and anger management. The study team added additional culturally meaningful content, graphics, music, videos, recovery tools, and testimonials. Connections uses a HIPAA and HITRUST compliant interactive peer platform, which allows users to privately message one another and/or participate in group chats. The investigators will utilize the app's mass messaging and group chat capabilities to engage participants in facilitated discussions that are consistent with the policies, services, and treatment philosophies of SCF. The study team will add additional topics such as sobriety, lifestyle changes, cultural content, and skill-building modules based on the Community Reinforcement Approach.
Participants will be asked to utilize the app for at least 3 months, with a 6-month follow-up. Participation in the study will be entirely voluntary and confidential. The investigators plan to recruit no more than 125 AN/AI adults who report a desire to change their alcohol use patterns. The investigators will attempt to recruit at SCF in such a way as to have adequate representation from urban and rural residing customer-owners. Individuals may or may not be engaged in or have a history of treatment services specifically for alcohol use disorders. The investigators will not access customer-owners' medical records for recruitment purposes. The investigators also plan to interview up to 25 participants at the 6-month mark, gathering qualitative data about their experiences using the app.
Data Analytic Plan:
Interviews will be transcribed verbatim and de-identified prior to analysis. Transcripts will be validated for accuracy and uploaded to ATLAS.ti for data management and coding, with categorical demographic information. Members of the qualitative research team will conduct analysis in four iterative steps: (1) familiarizing themselves with the data, (2) generating or applying a priori and emergent codes to the data, (3) searching for thematic patterns, and (4) searching for demographic patterns. Consistency will be maintained through a shared codebook, team coding of selected transcripts, and regular meetings to discuss and resolve discrepancies.
Data analysis of feasibility and acceptability of the Connections app will include descriptive statistics of counts of interaction with the app and total number of days the app was accessed. Bivariate descriptive statistics will be used to examine differences in feasibility by demographics and baseline observations.
Data analysis for survey data will include descriptive statistics and mixed effects modeling to account for correlation of repeated measures within customer-owner participants for quality of life, alcohol use and problems, self-efficacy in sobriety, and stages of change completed in partnership with our external consultants. As part of this analysis, data will be evaluated for selection bias, and measurement error or misclassification bias that are common challenges in repeated measures and longitudinal public health datasets.
- Conditions
- Alcohol Use Disorder
- Being tested
- CIRCLE mHealth app
- Keywords
- Alaska Native, mHealth app, behavioral interventions, alcohol use disorder
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIRCLE mHealth appBehavioural
Also called Connections, created by CHESS Health
For the intervention, participants will be given access to an mHealth sobriety app that has been modified for Alaska Native/American Indian people. The app allows people to track their sobriety, learn new recovery skills, track treatment plans, set reminders, journal about their recovery, and discover helpful videos and testimonials through an extensive resource library that includes culturally meaningful content, graphics, music, videos, recovery tools, and testimonials. Users can also participate in an interactive peer platform and/or participate in group chats to engage participants in facilitated discussions about sobriety, lifestyle changes, cultural content, and Community Reinforcement Approach skill-building.
| Study group | Role | What they receive |
|---|---|---|
| CIRCLE mHealth app | Experimental | The investigators will trial a modified version of the mHealth app called "Connections" with Alaska Native/American Indian people who want to change the way they use alcohol. Receives: Behavioral: CIRCLE mHealth app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and acceptability of the app
Through qualitative interviews, determine the feasibility and acceptability of the Connections app with Alaska Native and American Indian people to modify drinking behavior. 25 participants will be interviewed after they have trialed the app over a 6 month time period.
Measured: 6 months post app use
Changes in alcohol and drug use over time
Examine changes in alcohol and drug use with the Alcohol Use Disorders Identification Test - 3 (3 items). The scale is scored from 0-12 (where scores of 0 reflect no alcohol use). The higher the score, the more likely it is that the person's drinking is affecting his/her health and safety; higher scores thus reflect greater use of alcohol and is a worse outcome. All participants will be queried.
Measured: Baseline, 3 months after using app, 6 months after using app
Changes in self-efficacy to avoid drinking
Examine changes in self-efficacy to modify behavior over time of app use using a single item: "How confident are you that you will be able to manage your drinking in the next 90 days, or 3 months?" Scores range from 1 (no confidence) to 10 (very confident). Higher scores indicate greater confidence and better outcome. All participants will be queried.
Measured: Baseline, 3 months after using app, 6 months after using app
Changes in alcohol associated problems
Examine whether problems associated with drinking changes over time using the Short Inventory of Problems - Revised. This questionnaire has 6 items and responses are answered from "0" (never) to "3" (always), with answers ranging from 0 to 18. Lower scores mean fewer problems; higher scores mean greater problems and suggest a worse outcome. All participants will be queried.
Measured: Baseline, 3 months after using app, 6 months after using app
Changes in motivation to change alcohol use
Examine whether readiness for treatment changes over time using the Stages of Change Readiness and Treatment Eagerness Scale (19 items). Lower scores indicate poorer readiness, higher scores indicate better outcome and higher motivation. Scores range from 19 to 95. All participants will be queried.
Measured: Baseline, 3 months after using app, 6 months after using app
Changes in quality of life scores
Examine World Health Organization Quality-of-Life Scale to evaluate physical, psychological, social, environmental changes in quality of life, as well as overall quality of life and health. The 26-item instrument covers four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains quality of life and general health items. Each individual item of the scale is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale. Higher scores indicate better outcome, or better quality of life. All participants will be queried.
Measured: Baseline, 3 months after using app, 6 months after using app
Changes in positive and negative affect scores
Examine positive and negative affect using the short form of the positive and negative affect schedule. There are two subscales, five items for positive affect and five items for negative affect. The scale is answered from "1" for very slightly or not at all to "5" for extreme. Scores on each scale can range from 5 to 25. Lower scores indicate less of this type of affect. Higher positive affect scores is a better outcome for the study; higher negative affect scores is a poorer outcome for the study. All participants will be queried.
Measured: Baseline, 3 months after using app, 6 months after using app
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start10 Aug 2022
- Primary completion15 Jun 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southcentral Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington
- Responsible party
- Sponsor
- Investigators
- Ann D Collier, Ph.D., Principal investigator, Southcentral Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326438
- Sponsor's protocol ID
- 2021-12-056
- Acronym
- CIRCLE
- Status last verified
- May 2023
- First submitted
- 15 Mar 2022
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bush K, Kivlahan DR, McDonell MB, Fihn SD, Bradley KA. The AUDIT alcohol consumption questions (AUDIT-C): an effective brief screening test for problem drinking. Ambulatory Care Quality Improvement Project (ACQUIP). Alcohol Use Disorders Identification Test. Arch Intern Med. 1998 Sep 14;158(16):1789-95. doi: 10.1001/archinte.158.16.1789.
PubMed 9738608Hoeppner BB, Kelly JF, Urbanoski KA, Slaymaker V. Comparative utility of a single-item versus multiple-item measure of self-efficacy in predicting relapse among young adults. J Subst Abuse Treat. 2011 Oct;41(3):305-12. doi: 10.1016/j.jsat.2011.04.005. Epub 2011 Jun 22.
PubMed 21700411Kiluk BD, Dreifuss JA, Weiss RD, Morgenstern J, Carroll KM. The Short Inventory of Problems - revised (SIP-R): psychometric properties within a large, diverse sample of substance use disorder treatment seekers. Psychol Addict Behav. 2013 Mar;27(1):307-14. doi: 10.1037/a0028445. Epub 2012 May 28.
PubMed 22642856Maisto SA, Conigliaro J, McNeil M, Kraemer K, O'Connor M, Kelley ME. Factor structure of the SOCRATES in a sample of primary care patients. Addict Behav. 1999 Nov-Dec;24(6):879-92. doi: 10.1016/s0306-4603(99)00047-7.
PubMed 10628520Thompson, E. R. (2007). Development and validation of an internationally reliable short-form of the positive and negative affect schedule (PANAS). Journal of cross-cultural psychology, 38(2), 227-242.
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cultural Innovations for Recovery in Community-Based Learning Environments (CIRCLE) Phase 3: Testing an Online Learning Community Application
- ClinicalTrials.gov ID
- NCT05326438
- Acronym / sponsor ID
- CIRCLE / 2021-12-056
- Conditions
- Alcohol Use Disorder
- Keywords
- Alaska Native, mHealth app, behavioral interventions, alcohol use disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Southcentral FoundationUniversity, hospital or other
- Collaborators
- University of Washington
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 13 Apr 2022 (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.
For many people who have trouble with alcohol, peer support - the opportunity to share challenges, problem-solving strategies, and successes with supportive others - can be helpful. Building on Southcentral Foundation's (SCF's) established learning circles for sobriety support, the goal of this study is to culturally adapt and test the acceptability and feasibility of a smartphone app for sobriety support among Alaska Native and American Indian (AN/AI) people. In Aims 1 and 2 of this study, the investigators used input from patients and providers to culturally adapt a commercially available mHealth app for AN/AI people dealing with alcohol misuse. The investigators then merged culturally relevant content (e.g., stories and music) and skill-building modules based on the Community Reinforcement Approach with the existing informational and peer support features of the Connections app, a product of CHESS Health accessible on smartphones and tablets. The investigators will work with up to 125 SCF patients to assess the acceptability, feasibility, and measurable effects of the culturally-adapted app among AN/AI adults 21 and older, relying on questionnaires and interviews to evaluate the app features and utility.
The study's primary outcome is the feasibility and acceptability of the modified CHESS app for AN/AI people as a tool for sobriety. The secondary outcomes are to examine changes in quality of life, alcohol use and problems, self-efficacy in sobriety, and stages of change over the course of using the app. The investigators will also explore whether alcohol use and problems are mediated by frequency of app use, app satisfaction, and alcohol self-efficacy.
Detailed description
Southcentral Foundation (SCF) has a long history of stakeholder engagement, recognizing that engaged patients seek out information, work collaboratively with providers, and are more likely to demonstrate healthy choices and disease-specific self-management behaviors. SCF has used qualitative methods to identify and meet the changing needs of patients. Building on work in Aim 1 and Aim 2, which provided patient feedback about both the Connections app and the intended measurement tools, work in this Aim will include testing a modified version of the app with SCF patients.
The Connections app supports individuals in recovery by reducing relapse and promoting prosocial engagement. The app allows people to track their sobriety, learn new recovery skills, track treatment plans, set reminders, journal about their recovery, and discover helpful videos and testimonials through an extensive resource library. The app also has a "recovery help button" that can be pressed whenever the participant needs urgent help. Examples of Connections content include motivational talks, meditations, addiction recovery speakers, stress management, and anger management. The study team added additional culturally meaningful content, graphics, music, videos, recovery tools, and testimonials. Connections uses a HIPAA and HITRUST compliant interactive peer platform, which allows users to privately message one another and/or participate in group chats. The investigators will utilize the app's mass messaging and group chat capabilities to engage participants in facilitated discussions that are consistent with the policies, services, and treatment philosophies of SCF. The study team will add additional topics such as sobriety, lifestyle changes, cultural content, and skill-building modules based on the Community Reinforcement Approach.
Participants will be asked to utilize the app for at least 3 months, with a 6-month follow-up. Participation in the study will be entirely voluntary and confidential. The investigators plan to recruit no more than 125 AN/AI adults who report a desire to change their alcohol use patterns. The investigators will attempt to recruit at SCF in such a way as to have adequate representation from urban and rural residing customer-owners. Individuals may or may not be engaged in or have a history of treatment services specifically for alcohol use disorders. The investigators will not access customer-owners' medical records for recruitment purposes. The investigators also plan to interview up to 25 participants at the 6-month mark, gathering qualitative data about their experiences using the app.
Data Analytic Plan:
Interviews will be transcribed verbatim and de-identified prior to analysis. Transcripts will be validated for accuracy and uploaded to ATLAS.ti for data management and coding, with categorical demographic information. Members of the qualitative research team will conduct analysis in four iterative steps: (1) familiarizing themselves with the data, (2) generating or applying a priori and emergent codes to the data, (3) searching for thematic patterns, and (4) searching for demographic patterns. Consistency will be maintained through a shared codebook, team coding of selected transcripts, and regular meetings to discuss and resolve discrepancies.
Data analysis of feasibility and acceptability of the Connections app will include descriptive statistics of counts of interaction with the app and total number of days the app was accessed. Bivariate descriptive statistics will be used to examine differences in feasibility by demographics and baseline observations.
Data analysis for survey data will include descriptive statistics and mixed effects modeling to account for correlation of repeated measures within customer-owner participants for quality of life, alcohol use and problems, self-efficacy in sobriety, and stages of change completed in partnership with our external consultants. As part of this analysis, data will be evaluated for selection bias, and measurement error or misclassification bias that are common challenges in repeated measures and longitudinal public health datasets.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CIRCLE mHealth app | Experimental | Behavioral: CIRCLE mHealth appThe investigators will trial a modified version of the mHealth app called "Connections" with Alaska Native/American Indian people who want to change the way they use alcohol. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Alaska Native/American Indian;
- ≥ 21 years of age;
- Having a desire to change drinking behavior;
- Receiving services at Southcentral Foundation and reside in the Anchorage Service Unit (urban and rural);
- English-speaking;
Key exclusion criteria (4 listed)
- Not Alaska Native/American Indian;
- Non-English speaking;
- Having a medical or severe psychiatric condition that the PIs determine would make it difficult for the individual to use the app or participate in the interview;
- Not having access to a smartphone or tablet (e.g., iPad, Kindle Fire, etc.).
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 |
|---|---|---|
| CIRCLE mHealth appAlso: Connections, created by CHESS HealthFor the intervention, participants will be given access to an mHealth sobriety app that has been modified for Alaska Native/American Indian people. The app allows people to track their sobriety, learn new recovery skills, track treatment plans, set reminders, journal about their recovery, and discover helpful videos and testimonials through an extensive resource library that includes culturally meaningful content, graphics, music, videos, recovery tools, and testimonials. Users can also participate in an interactive peer platform and/or participate in group chats to engage participants in facilitated discussions about sobriety, lifestyle changes, cultural content, and Community Reinforcement Approach skill-building. | Behavioural | CIRCLE mHealth app |
Primary outcome
Feasibility and acceptability of the app
Time frame: 6 months post app use
Through qualitative interviews, determine the feasibility and acceptability of the Connections app with Alaska Native and American Indian people to modify drinking behavior. 25 participants will be interviewed after they have trialed the app over a 6 month time period.
Changes in alcohol and drug use over time
Time frame: Baseline, 3 months after using app, 6 months after using app
Examine changes in alcohol and drug use with the Alcohol Use Disorders Identification Test - 3 (3 items). The scale is scored from 0-12 (where scores of 0 reflect no alcohol use). The higher the score, the more likely it is that the person's drinking is affecting his/her health and safety; higher scores thus reflect greater use of alcohol and is a worse outcome. All participants will be queried.
Changes in self-efficacy to avoid drinking
Time frame: Baseline, 3 months after using app, 6 months after using app
Examine changes in self-efficacy to modify behavior over time of app use using a single item: "How confident are you that you will be able to manage your drinking in the next 90 days, or 3 months?" Scores range from 1 (no confidence) to 10 (very confident). Higher scores indicate greater confidence and better outcome. All participants will be queried.
Changes in alcohol associated problems
Time frame: Baseline, 3 months after using app, 6 months after using app
Examine whether problems associated with drinking changes over time using the Short Inventory of Problems - Revised. This questionnaire has 6 items and responses are answered from "0" (never) to "3" (always), with answers ranging from 0 to 18. Lower scores mean fewer problems; higher scores mean greater problems and suggest a worse outcome. All participants will be queried.
Changes in motivation to change alcohol use
Time frame: Baseline, 3 months after using app, 6 months after using app
Examine whether readiness for treatment changes over time using the Stages of Change Readiness and Treatment Eagerness Scale (19 items). Lower scores indicate poorer readiness, higher scores indicate better outcome and higher motivation. Scores range from 19 to 95. All participants will be queried.
Changes in quality of life scores
Time frame: Baseline, 3 months after using app, 6 months after using app
Examine World Health Organization Quality-of-Life Scale to evaluate physical, psychological, social, environmental changes in quality of life, as well as overall quality of life and health. The 26-item instrument covers four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains quality of life and general health items. Each individual item of the scale is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale. Higher scores indicate better outcome, or better quality of life. All participants will be queried.
Changes in positive and negative affect scores
Time frame: Baseline, 3 months after using app, 6 months after using app
Examine positive and negative affect using the short form of the positive and negative affect schedule. There are two subscales, five items for positive affect and five items for negative affect. The scale is answered from "1" for very slightly or not at all to "5" for extreme. Scores on each scale can range from 5 to 25. Lower scores indicate less of this type of affect. Higher positive affect scores is a better outcome for the study; higher negative affect scores is a poorer outcome for the study. All participants will be queried.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Results publication: PubMed 9738608Bush K, Kivlahan DR, McDonell MB, Fihn SD, Bradley KA. The AUDIT alcohol consumption questions (AUDIT-C): an effective brief screening test for problem drinking. Ambulatory Care Quality Improvement Project (ACQUIP). Alcohol Use Disorders Identification Test. Arch Intern Med. 1998 Sep 14;158(16):1789-95. doi: 10.1001/archinte.158.16.1789.
- Results publication: PubMed 21700411Hoeppner BB, Kelly JF, Urbanoski KA, Slaymaker V. Comparative utility of a single-item versus multiple-item measure of self-efficacy in predicting relapse among young adults. J Subst Abuse Treat. 2011 Oct;41(3):305-12. doi: 10.1016/j.jsat.2011.04.005. Epub 2011 Jun 22.
- Results publication: PubMed 22642856Kiluk BD, Dreifuss JA, Weiss RD, Morgenstern J, Carroll KM. The Short Inventory of Problems - revised (SIP-R): psychometric properties within a large, diverse sample of substance use disorder treatment seekers. Psychol Addict Behav. 2013 Mar;27(1):307-14. doi: 10.1037/a0028445. Epub 2012 May 28.
- Results publication: PubMed 10628520Maisto SA, Conigliaro J, McNeil M, Kraemer K, O'Connor M, Kelley ME. Factor structure of the SOCRATES in a sample of primary care patients. Addict Behav. 1999 Nov-Dec;24(6):879-92. doi: 10.1016/s0306-4603(99)00047-7.
- Results publicationThompson, E. R. (2007). Development and validation of an internationally reliable short-form of the positive and negative affect schedule (PANAS). Journal of cross-cultural psychology, 38(2), 227-242.
- WHO Quality of Life Scale, BREF versionLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Ann D Collier, Ph.D. principal investigator
Southcentral Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CIRCLE mHealth app in people with Alcohol Use Disorder, run by Southcentral Foundation 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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and acceptability of the app (time frame: 6 months post app use). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05326438, which also lists 5 linked publications.
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 23 May 2023.