Health Improvement Project - Providence

NCT02886234 | Completed Results DMC

• 1 other identifier: R34AT008930
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV

Keywords

HIV; Mindfulness; Adherence behaviors; Stress; Depression

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Acceptability of the Intervention

  post-intervention, 9 to 10 weeks after baseline

• Antiretroviral Medication Adherence

  Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline

• Self-reported Sexual Risk Behavior

  Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline

• Five Facet Mindfulness Questionnaire

  Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline

• Perceived Stress Scale

  Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline

Study Arms (2)

Mindfulness training (MT)

EXPERIMENTAL

Eight, 30-minute phone delivered MT sessions once a week for 8 weeks

Behavioral: Mindfulness Training (MT)

Health Coaching (HC)

ACTIVE COMPARATOR

Eight, 30-minute phone delivered HC sessions once a week for 8 weeks

Behavioral: Health Coaching (HC)

Interventions

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.

Mindfulness training (MT)

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

Health Coaching (HC)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV infection
• Sub-optimal adherence to ART (Less than "always" taking ART medication and/or viral load \> 20 copies/mL);
• Psychological distress (PHQ-4 score ≥ 2);
• Recent risky sexual behavior (any unprotected sex OR \> 1 sexual partner over the past 6 months)
• Access to a telephone or cell phone

You may not qualify if:

• Unwilling or unable to provide informed consent
• Cognitive impairment
• Non-English speaking
• Low literacy (i.e., reporting they "often" or "always" need someone to read instructions, pamphlets, or other written material from a doctor or pharmacy to them
• Enrolled in another behavioral trials
• Prior formal mindfulness training or have practiced of mindfulness or related mind-body techniques in the previous year
• Severe hearing impairment not allowing phone delivery
• Suicidal ideation
• Planning to move out of the area within the study period
• Clinic provider advising against recruitment in the study.

Sponsors & Collaborators

• The Miriam Hospital: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Michael Carey
• Organization: The Miriam Hospital

michael_carey@brown.edu

401793-8218

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director, Centers for Preventive and Behavioral Medicine, The Miriam Hospital

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: September 1, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: January 13, 2020
• Results First Posted: January 13, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)