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| ID | Type | Description | Link |
|---|---|---|---|
| R34AT008930 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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This study will investigate whether phone-delivered mindfulness training is feasible and acceptable for persons living with HIV and whether it may help them improve adherence to medications and reduce risky sexual behaviors.
Two-thirds of people living with HIV show sub-optimal adherence to antiretroviral therapy (ART) and one-third engages in risky sex. Both non-adherence and risky sex have been associated with emotional distress and impulsivity. In this trial, the investigators will examine the utility of phone-delivered mindfulness training (MT) for people living with HIV. The primary outcomes comprise feasibility and acceptability of phone-delivery; secondary outcomes are estimates of efficacy of MT on adherence to ART and safer sexual practices as well as on their hypothesized antecedents.
Fifty participants will be enrolled in this parallel-group randomized clinical trial (RCT). Outpatients recruited from an HIV treatment clinic will be randomized (1:1 ratio) to either MT or to health coaching intervention; both interventions will be administered during 8 weekly phone calls. ART adherence (self-reported measure and unannounced phone pill counts), sexual behavior (self-reports and biomarkers), mindfulness, depression, stress, and impulsivity will be measured at baseline, post-intervention, and 3 months post-intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness training (MT) | Experimental | Eight, 30-minute phone delivered MT sessions once a week for 8 weeks |
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| Health Coaching (HC) | Active Comparator | Eight, 30-minute phone delivered HC sessions once a week for 8 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Training (MT) | Behavioral | Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Intervention | Feasibility - as indicated by the number of patients attending at least 50% of sessions | post-intervention, 9 to 10 weeks after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of the Intervention | Number of patients reporting "very satisfied" or "mostly satisfied" with their intervention | post-intervention, 9 to 10 weeks after baseline |
| Antiretroviral Medication Adherence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MIchael P Carey, PhD | Centers for Behavioral and Preventive Medicine, The Miriam Hospital | Principal Investigator |
| Elena Salmoirago-Blotcher, MD, PhD | Centers for Behavioral and Preventive Medicine, The Miriam Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Miriam Hospital | Providence | Rhode Island | 02906 | United States |
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Prior to being randomized, patients had to complete all baseline activities, which included two months of counting to establish a baseline adherence measure. During this interval, 6 patients withdrew from the study. Thus, 44 patients were randomized (24 to health coaching arm, and 20 to the mindfulness training arm).
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| ID | Title | Description |
|---|---|---|
| FG000 | Mindfulness Training (MT) | Eight, 30-minute phone delivered MT sessions once a week for 8 weeks Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor. |
| FG001 | Health Coaching (HC) | Eight, 30-minute phone delivered HC sessions once a week for 8 weeks Health Coaching (HC): The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Mindfulness Training (MT) | Eight, 30-minute phone delivered MT sessions once a week for 8 weeks Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of Intervention | Feasibility - as indicated by the number of patients attending at least 50% of sessions | Posted | Count of Participants | Participants | post-intervention, 9 to 10 weeks after baseline |
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Adverse events were monitored throughout the trial, starting at baseline and continuing through the initial pill count phase of baseline (2 months), the intervention period (2 months), and during the 3-month follow-up period (3 months). Thus, adverse events were monitored for a total of 7 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mindfulness Training (MT) | Eight, 30-minute phone delivered MT sessions once a week for 8 weeks Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Carey | The Miriam Hospital | 401793-8218 | michael_carey@brown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 27, 2017 | Dec 2, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 27, 2017 | Dec 2, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Health Coaching (HC) | Behavioral | The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics |
|
Self-reported number of missed days of medication
| Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline |
| Self-reported Sexual Risk Behavior | Self-reported risky sexual behavior as indicated by the percentage of episodes of condom protected sexual intercourse Higher values are better outcome | Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline |
| Five Facet Mindfulness Questionnaire | Five Facet of Mindfulness Questionnaire (15 items; short form) Construct = Mindfulness Minimum total scale score = 15 Maximum total scale score = 75 Scoring: sum across all 15 items Higher scores represent a better outcome | Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline |
| Perceived Stress Scale | Perceived Stress Scale (4-item version) Construct = perceived stress Minimum total scale score = 0 Maximum total scale score = 16 Scoring: reverse score items 2 and 3, then sum across all 4 items Higher scores represent a worse outcome | Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline |
| Barratt Impulsiveness Scale | Barratt Impulsiveness Scale (short form, 8 items) Construct = Impulsivity Minimum total scale score = 8 Maximum total scale score = 32 Scoring: reverse score items 1, 4, 5, 6, and then sum across all 8 items Higher scores represent a worse outcome | Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline |
| Patient Health Questionnaire | Patient Health Questionnaire (9 item version) Construct measured = depression Minimum total scale score = 0 Maximum total scale score = 27 Scoring: sum across all 9 items Higher scores represent a worse outcome | Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline |
| BG001 | Health Coaching (HC) | Eight, 30-minute phone delivered HC sessions once a week for 8 weeks Health Coaching (HC): The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Eight, 30-minute phone delivered HC sessions once a week for 8 weeks Health Coaching (HC): The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics |
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| Secondary | Acceptability of the Intervention | Number of patients reporting "very satisfied" or "mostly satisfied" with their intervention | 3 participants in the MT arm did not complete the acceptability rating at the post-intervention assessment | Posted | Count of Participants | Participants | post-intervention, 9 to 10 weeks after baseline |
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| Secondary | Antiretroviral Medication Adherence | Self-reported number of missed days of medication | Posted | Mean | Standard Deviation | days | Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline |
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| Secondary | Self-reported Sexual Risk Behavior | Self-reported risky sexual behavior as indicated by the percentage of episodes of condom protected sexual intercourse Higher values are better outcome | Posted | Mean | Standard Deviation | percentage of sexual events condom used | Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline |
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| Secondary | Five Facet Mindfulness Questionnaire | Five Facet of Mindfulness Questionnaire (15 items; short form) Construct = Mindfulness Minimum total scale score = 15 Maximum total scale score = 75 Scoring: sum across all 15 items Higher scores represent a better outcome | Posted | Mean | Standard Deviation | score on a scale | Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline |
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| Secondary | Perceived Stress Scale | Perceived Stress Scale (4-item version) Construct = perceived stress Minimum total scale score = 0 Maximum total scale score = 16 Scoring: reverse score items 2 and 3, then sum across all 4 items Higher scores represent a worse outcome | Posted | Mean | Standard Deviation | score on a scale | Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline |
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| Secondary | Barratt Impulsiveness Scale | Barratt Impulsiveness Scale (short form, 8 items) Construct = Impulsivity Minimum total scale score = 8 Maximum total scale score = 32 Scoring: reverse score items 1, 4, 5, 6, and then sum across all 8 items Higher scores represent a worse outcome | Posted | Mean | Standard Deviation | score on a scale | Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline |
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| Secondary | Patient Health Questionnaire | Patient Health Questionnaire (9 item version) Construct measured = depression Minimum total scale score = 0 Maximum total scale score = 27 Scoring: sum across all 9 items Higher scores represent a worse outcome | Posted | Mean | Standard Deviation | score on a scale | Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline |
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Health Coaching (HC) | Eight, 30-minute phone delivered HC sessions once a week for 8 weeks Health Coaching (HC): The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics | 0 | 22 | 0 | 22 | 0 | 22 |
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| 3-month Follow-up |
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| 3-month Follow-up |
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| 3-month Follow-up |
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| 3-month Follow-up |
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| 3-month Follow-up |
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| 3-month Follow-up |
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