Pilot Study of Annie Text Messaging for Depression Treatment Adherence

Pilot Study of Technology Assisted Depression Treatment Adherence

Patients and providers need effective tools to help promote adherence to newly prescribed medications for depression and to determine if this medication is improving depressed mood. This study will test an intervention that uses 1) VA's text messaging program called Annie to help patient's engage in self-management when starting a new medication for depression and 2) My HealtheVet, VA's patient portal, for education and communication with their VA health care team. The goals of this intervention are to improve adherence to depression medication and depressive symptoms in Veterans.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: AIMS; Behavioral: AIMS plus

Detailed Description

Background: There are several known challenges to starting a medication for depression, such as side effects and needing four to six weeks before the effects of the medication may be noticed. This pilot randomized controlled trial will compare usual care to an intervention which aims to improve antidepressant adherence and depression outcomes in Veterans initiating medication to treat depression by using Annie, VA's short messaging services (SMS) application and My HealtheVet, VA's patient portal.

Method: Veterans will be eligible if they are initiating a new antidepressant medication as part of their care at the Iowa City VA primary care or mental health. Veterans will be randomized to one of three groups, usual care or 1 of 2 interventional groups (Annie or Annie plus). Veterans in the intervention groups will 1) receive education about depression and the importance of taking medications as prescribed and 2) receive text messages from "Annie" with information and questions for response. For example, are Veterans taking their medication, is their medication working, and how would they rate their mood. They will also receive weekly reports about their responses to Annie through My HealtheVet, VA's patient portal. In addition, Veterans assigned to Annie Plus will receive a weekly phone call to review progress and to answer any questions. Prior to a participant's scheduled follow-up appointment, a summary of information collected to date via Annie will be made available to the clinical team in the medical record. At the end of the study, participants will be invited to complete a recorded interview about their experiences using the Annie text messaging program and to provide any recommendations for changes. VA providers will also be invited to complete a recorded phone interview about their experience with patients using Annie.

For Veterans randomized to the control condition, research staff will provide education about depression and the importance of taking medications as prescribed. Staff will contact participants in this arm by phone just prior to scheduled follow up visits to discuss any concerns the patient may be experiencing. A sample of Veterans will be asked to complete a recorded interview about their medication management at the end of the study.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52246-2292
      • Iowa City VA Health Care System, Iowa City, IA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

VA Patient

• Diagnosed with depression
• Initiating or changing to a new antidepressant medication
• Cell phone with text messaging capabilities
• Registered with My HealtheVet
• Follow-up appointment with their provider in the next 12 weeks
• Internet access
• English speaking VA Providers: provide care to a study participant

Exclusion Criteria:

• Lack of cell phone access/willingness to receive text messages
• Diagnosis of cognitive disorders, psychotic disorders, bipolar disorder, or active substance abuse.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AIMS Intervention; Participants randomized to the AIMS arm be enrolled in VA's Annie text messaging program and receive the study protocol.	Behavioral: AIMS; Participants randomized to the AIMS arm be enrolled in VA's Annie text messaging program and receive the study protocol. Annie text messages will ask the participate to provide feedback about specific domains related to their depression treatment and goals. The Veteran participant will receive a weekly report about their Annie responses through My HealtheVet, VA's patient portal, and instructed to share information with their care team at their next scheduled appointment. In addition, a summary of response will be provided to the participant's clinician prior to their appointment(s) during the studies 12 week time frame.
No Intervention: No Intervention; Participants randomized to the no intervention arm will not be enrolled in the Annie text messaging program.
Experimental: AIMS Intervention Plus; Participants randomized to the AIMS Intervention Plus arm will be enrolled in VA's Annie text messaging program/study protocol and receive a weekly phone call.	Behavioral: AIMS plus; Participants randomized to the AIMS Plus arm will receive a weekly phone call in addition to being enrolled in VA's Annie text messaging program/study protocol. Annie text messages will ask the participate to provide feedback about specific domains related to their depression treatment and goals. The Veteran participant will receive a weekly report about their Annie responses through My HealtheVet, VA's patient portal, and instructed to share information with their care team at their next scheduled appointment. In addition, a summary of response will be provided to the participant's clinician prior to their appointment(s) during the studies 12 week time frame.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Adherence at Baseline, 6 Weeks and 12 Weeks	Medication Adherence Rating Scale - 10 item self-report measure of medication taking attitudes, behaviors, and side effects. It is scored on a 0-10 scale with higher scores indicating greater adherence.	Baseline, 6 and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive Symptoms at Baseline, 6 Weeks and 12 Weeks	Patient Health Questionnaire (PHQ-9) - a standard instrument for measuring depressive symptom severity and monitoring treatment outcomes over time. A score of 4 or less indicates minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, and 20-27 indicates severe depression. The total score may range from 0 -27.	Baseline, 6 and 12 weeks
Medication Side Effects at Baseline, 6 Weeks, and 12 Weeks	The Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER): The 3-item FIBSER asks about the frequency, severity, and functional impact of antidepressant side effects using a 0 to 6- Likert scale. The prevalence and distribution of scores for each domain will be compared across assessment time points. Higher scores indicate greater side effect burden while lower scores indicate lesser. The range for the total score on the measure can span from 0 to 18. A decline in total score is the desired outcome.	Baseline, 6 and 12 weeks

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Carolyn L Turvey, PhD MS, Iowa City VA Health Care System, Iowa City, IA

Publications and helpful links

General Publications

• Van Tiem J, Moeckli J, Suiter N, Fuhrmeister L, Pham K, Dindo L, Turvey C. "A link to the outside:" Patient perspectives on a mobile texting program to improve depression self-management. Patient Educ Couns. 2021 Sep;104(9):2154-2158. doi: 10.1016/j.pec.2021.02.018. Epub 2021 Feb 11.

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2019
• Primary Completion (Actual): May 31, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: April 16, 2019
• First Submitted That Met QC Criteria: April 25, 2019
• First Posted (Actual): April 29, 2019

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Depression; Patient Participation; Text messaging; Patient Portals
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: PPO 18-111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Original VA funded datasets will be retained on VA servers behind VA firewalls. These data will be provided to interested parties following proper filing and verification of a FOIA request and approval by the Privacy Officer. These data will be maintained as required by VA data retention policies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No