DepressionNCT03930849

Pilot Study of Annie Text Messaging for Depression Treatment Adherence

A study testing AIMS and AIMS plus in people with Depression, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Depression
What is being tested?: AIMS and AIMS plus
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 1 siteUnited States
Study dates: 21 Jun 2019to 30 Jun 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Iowa City VA Health Care System, Iowa City, IA
Iowa City, Iowa, 52246-2292

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Depression
Being tested: AIMS, AIMS plus
Keywords: Depression, Patient Participation, Text messaging, Patient Portals
Medical subject headings: Depression, Patient Participation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AIMSBehavioural
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.
AIMS plusBehavioural
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.

Study groups in NCT03930849
Study group	Role	What they receive
AIMS Intervention	Experimental	Participants randomized to the AIMS arm be enrolled in VA's Annie text messaging program and receive the study protocol. Receives: Behavioral: AIMS
No Intervention	No intervention	Participants randomized to the no intervention arm will not be enrolled in the Annie text messaging program.
AIMS Intervention Plus	Experimental	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. Receives: Behavioral: AIMS plus

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, 6 and 12 weeks

Secondary outcomes (2)

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.
Measured: 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.
Measured: Baseline, 6 and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jun 201930 Jun 2020

First posted29 Apr 2019
Study start21 Jun 2019
Primary completion31 May 2020
Study completion30 Jun 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for DepressionStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Model description: This study will test an intervention designed to improve antidepressant adherence and depression outcomes in Veterans initiating or changing antidepressant medication to treat depression. Veterans will be assigned to 1) use Annie, VA's short message service (SMS) in combination with My HealtheVet, VA's online patient portal, 2) use Annie plus receive a weekly phone call, or 3) to the control group who will not be enrolled in Annie.
Masking: None (open label)
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03930849
Sponsor's protocol ID: PPO 18-111
Status last verified: Jul 2023
First submitted: 16 Apr 2019
Last updated: 27 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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.

Publications

Turvey C, Fuhrmeister L, Klein D, McCoy K, Moeckli J, Stewart Steffensmeier KR, Suiter N, Van Tiem J. Secure Messaging Intervention in Patients Starting New Antidepressant to Promote Adherence: Pilot Randomized Controlled Trial. JMIR Form Res. 2023 Dec 8;7:e51277. doi: 10.2196/51277.
PubMed 38064267
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.
PubMed 33627234

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study of Technology Assisted Depression Treatment Adherence
ClinicalTrials.gov ID: NCT03930849
Acronym / sponsor ID: PPO 18-111
Conditions: Depression
Keywords: Depression, Patient Participation, Text messaging, Patient Portals
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 21 Jun 2019 (actual)
Primary completion: 31 May 2020 (actual)
Study completion: 30 Jun 2020 (actual)
First posted: 29 Apr 2019 (actual)
Results: Posted 18 Feb 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: This study will test an intervention designed to improve antidepressant adherence and depression outcomes in Veterans initiating or changing antidepressant medication to treat depression. Veterans will be assigned to 1) use Annie, VA's short message service (SMS) in combination with My HealtheVet, VA's online patient portal, 2) use Annie plus receive a weekly phone call, or 3) to the control group who will not be enrolled in Annie.

Arm	Type	Receives
AIMS Intervention	Experimental	Behavioral: AIMSParticipants randomized to the AIMS arm be enrolled in VA's Annie text messaging program and receive the study protocol.
No Intervention	No intervention	–Participants randomized to the no intervention arm will not be enrolled in the Annie text messaging program.
AIMS Intervention Plus	Experimental	Behavioral: AIMS plusParticipants 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.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

VA Patient
Diagnosed with depression
Initiating or changing to a new antidepressant medication
Cell phone with text messaging capabilities
Registered with My HealtheVet

Key exclusion criteria (2 listed)

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

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
AIMSParticipants 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.	Behavioural	AIMS Intervention
AIMS plusParticipants 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.	Behavioural	AIMS Intervention Plus

Primary outcome

Medication Adherence at Baseline, 6 Weeks and 12 Weeks
Time frame: Baseline, 6 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.

2 secondary outcomes

Depressive Symptoms at Baseline, 6 Weeks and 12 Weeks
Time frame: Baseline, 6 and 12 weeks
Medication Side Effects at Baseline, 6 Weeks, and 12 Weeks
Time frame: Baseline, 6 and 12 weeks

Results and safety

Results posted to the registry on 18 Feb 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AIMS Intervention	17	13
No Intervention	18	18
AIMS Intervention Plus	18	14

Primary outcome: Medication Adherence at Baseline, 6 Weeks and 12 Weeks

Time frame: Baseline, 6 and 12 weeks. Least squares mean (Standard Error). Unit: score on a scale

Measure	AIMS Intervention n = 13	No Intervention n = 18	AIMS Intervention Plus n = 14
Baseline	3.41 (0.46)	1.32 (0.45)	2.55 (0.45)
6-Weeks	2.66 (0.48)	1.44 (0.45)	2.16 (0.47)
12-Weeks	2.58 (0.48)	1.56 (0.45)	2.57 (0.48)

AIMS Intervention vs No Intervention: F-value for Type 3 Fixed, df=4: 2.01, p = 0.10, Mixed Models Analysis

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to 6-months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AIMS Intervention	0 of 17 (0%)	0 of 17 (0%)	0 of 17
No Intervention	0 of 18 (0%)	0 of 18 (0%)	0 of 18
AIMS Intervention Plus	0 of 18 (0%)	0 of 18 (0%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38064267Turvey C, Fuhrmeister L, Klein D, McCoy K, Moeckli J, Stewart Steffensmeier KR, Suiter N, Van Tiem J. Secure Messaging Intervention in Patients Starting New Antidepressant to Promote Adherence: Pilot Randomized Controlled Trial. JMIR Form Res. 2023 Dec 8;7:e51277. doi: 10.2196/51277.
Derived from this study: PubMed 33627234Van 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.
Individual participant dataSharing planned: No. 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.

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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.

Carolyn L Turvey, PhD MS principal investigator

Iowa City VA Health Care System, Iowa City, IA

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing AIMS and AIMS plus in people with Depression, run by VA Office of Research and Development 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 8 inclusion and 2 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: finished, as of the sponsor's last update on 27 Jul 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?

Yes. Results are posted in the registry (first posted 18 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Medication Adherence at Baseline, 6 Weeks and 12 Weeks (time frame: Baseline, 6 and 12 weeks). 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 NCT03930849, which also lists 2 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 27 Jul 2023.