title: Supportive text messages to reduce mood symptoms and problem drinking in patients with primary depression or alcohol use disorder: protocol for an implementation research study.
abstract: BACKGROUND
  Depression and Alcohol Use Disorders (AUDs) are two leading causes of disability worldwide and are associated with significant treatment challenges requiring new, innovative, cost-effective and technologically-based therapies including the use of supportive text messages.
  
  
  OBJECTIVE
  To determine the feasibility and effectiveness of supportive text messages in long-term follow-up to reduce mood symptoms and problem drinking in patients with Depression or AUD respectively and to explore the usefulness of self-reports of health services utilization as an outcomes measure.
  
  
  METHODS
  This will be a longitudinal, prospective, parallel-design, two-arm, placebo-controlled single-rater-blinded randomized clinical trial with a recruitment period of 6 months and an observation period of 12 months for each participant, with two strata based on primary diagnosis of Major Depressive Disorder or AUD. The sample size will be 120, with about 60 patients randomized from each primary diagnostic grouping. Patients in all intervention groups will receive twice-daily supportive SMS text messages for 3 months and then daily supportive text messages for the next three months. Patients will also receive a phone call every two weeks from the research assistant assigning treatment allocation to confirm that they are still receiving the text messages and to thank them for taking part in the study. Patients in the control group will receive no text messages but will also receive a phone call from the same research assistant every two weeks to thank them for taking part in the study.
  
  
  RESULTS
  The study starts in April 2015 and ends in September 2016. It is envisaged that both qualitative and quantitative primary and secondary outcomes, including patient perceptions of the intervention, will shed light on the feasibility of using automated supportive text message interventions in long term for patients with Depression and AUD. This will inform a full-scale clinical trial.
  
  
  CONCLUSIONS
  The paradigm for behavior change using text messages as a patient-direct intervention is consistent with a cognitive behavior therapy approach and addictions counselling principles. Given the automaticity of the messages, we anticipate that if the intervention proves successful, it will represent a low cost strategy that will be readily available and can bring relief to patients in hard-to-reach areas with limited access to psychological therapies.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT02327858; https://clinicaltrials.gov/ct2/show/NCT02327858 (Archived by WebCite at https://clinicaltrials.gov/ct2/show/NCT02327858).
authors.affiliation: Faculty of Health Sciences, Department of Psychiatry, University of Alberta, Edmonton, AB, Canada. agyapong@ualberta.ca.
authors.forename: Vincent Israel Opoku
authors.identifier: http://orcid.org/0000-0002-2743-0372
authors.initials: VI
authors.lastname: Agyapong
authors.forename: Kelly
authors.identifier: http://orcid.org/0000-0002-3887-1843
authors.initials: K
authors.lastname: Mrklas
authors.forename: Victoria Yung Mei
authors.identifier: http://orcid.org/0000-0002-7968-2934
authors.initials: VY
authors.lastname: Suen
authors.forename: Marianne Sarah
authors.identifier: http://orcid.org/0000-0001-5403-5506
authors.initials: MS
authors.lastname: Rose
authors.forename: Megan
authors.identifier: http://orcid.org/0000-0002-5148-6368
authors.initials: M
authors.lastname: Jahn
authors.forename: Irene
authors.identifier: http://orcid.org/0000-0002-9928-3367
authors.initials: I
authors.lastname: Gladue
authors.forename: Jody
authors.identifier: http://orcid.org/0000-0002-2843-3970
authors.initials: J
authors.lastname: Kozak
authors.forename: Maureen
authors.identifier: http://orcid.org/0000-0002-7318-1266
authors.initials: M
authors.lastname: Leslie
authors.forename: Serdar
authors.identifier: http://orcid.org/0000-0001-9943-851X
authors.initials: S
authors.lastname: Dursun
authors.forename: Arto
authors.identifier: http://orcid.org/0000-0002-7094-1573
authors.initials: A
authors.lastname: Ohinmaa
authors.forename: Andrew
authors.identifier: http://orcid.org/0000-0002-9097-900X
authors.initials: A
authors.lastname: Greenshaw
keywords: alcohol use disorder; depression; intervention; supportive text messages