NCT03930849

Pilot Study of Annie Text Messaging for Depression Treatment Adherence

Completed NA Results posted Last updated 27 July 2023

What this trial tests

NA trial testing AIMS in Depression in 53 participants. Completed in 30 June 2020.

Timeline

21 June 2019

Primary endpoint
31 May 2020

30 June 2020

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	53
Start date	21 June 2019
Primary completion	31 May 2020
Estimated completion	30 June 2020
Sites	1 location across United States

Drugs / interventions tested

• AIMS
• AIMS plus

Conditions studied

• Depression — all drugs for Depression →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 18 to 85, any sex, with Depression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Medication Adherence at Baseline, 6 Weeks and 12 Weeks Primary · 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.

Baseline

Group	Value	95% CI
AIMS Intervention	3.41	± 0.46
No Intervention	1.32	± 0.45
AIMS Intervention Plus	2.55	± 0.45

6-Weeks

Group	Value	95% CI
AIMS Intervention	2.66	± 0.48
No Intervention	1.44	± 0.45
AIMS Intervention Plus	2.16	± 0.47

12-Weeks

Group	Value	95% CI
AIMS Intervention	2.58	± 0.48
No Intervention	1.56	± 0.45
AIMS Intervention Plus	2.57	± 0.48

Depressive Symptoms at Baseline, 6 Weeks and 12 Weeks Secondary · Baseline, 6 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

Group	Value	95% CI
AIMS Intervention	15.41	± 1.43
No Intervention	13.27	± 1.38
AIMS Intervention Plus	12.00	± 1.38

6-Weeks

Group	Value	95% CI
AIMS Intervention	13.34	± 1.55
No Intervention	11.38	± 1.38
AIMS Intervention Plus	9.29	± 1.50

12-Weeks

Group	Value	95% CI
AIMS Intervention	12.20	± 1.58
No Intervention	11.45	± 1.40
AIMS Intervention Plus	8.70	± 1.56

Medication Side Effects at Baseline, 6 Weeks, and 12 Weeks Secondary · Baseline, 6 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

Group	Value	95% CI
AIMS Intervention	6.05	± 1.00
No Intervention	3.38	± 0.97
AIMS Intervention Plus	3.55	± 0.97

6-Weeks

Group	Value	95% CI
AIMS Intervention	3.83	± 1.11
No Intervention	4.88	± 0.97
AIMS Intervention Plus	1.51	± 1.07

12-Weeks

Group	Value	95% CI
AIMS Intervention	4.06	± 1.11
No Intervention	3.73	± 1.01
AIMS Intervention Plus	2.53	± 1.14

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Secure Messaging Intervention in Patients Starting New Antidepressant to Promote Adherence: Pilot Randomized Controlled Trial.
   Turvey C, Fuhrmeister L, Klein D, McCoy K, et al · · 2023 · cited 4× · PMID 38064267 · DOI 10.2196/51277