Supportive Text Messages to Reduce Mood Symptoms and Problem Drinking- Randomised Controlled Pilot Trials

NCT02327858 | Completed DMC

• 1 other identifier: Pro00054068
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 2

Brief Summary

According to the World Health Organisation, depression and problem drinking are among the leading causes of disability worldwide. Most patients who present with problem drinking and/or depression have poor quality of life and pose a great economic burden to society due to their higher use of health services. We seek to develop a new, enhanced, efficient, innovative and cost effective treatment strategy aimed at reducing the burden that these two mental conditions impose on sufferers, their families as well as the community and health systems. In a recent pilot study of supportive text messages in Ireland conducted by the Principal Applicant and a team of researchers for patients with problem drinking and co-occurring depression, we established that patients who received twice daily supportive text messages for three months had significantly less depressive symptoms than those who did not receive such messages. There was also a trend that patients who received the supportive text messages were more likely to have higher alcohol free days than those who did not receive any supportive text messages.Our study was limited by the small number of participants and it did not examine the impact of the text messages on health services utilization. Our study did not also examine the effects of supportive text messages on those with only depression or only problem drinking. The proposed study seeks to extend the knowledge gained from the pilot study in Ireland by examining the impact of supportive text messages in the individual disorders

Conditions

Depression; Alcoholism

Outcome Measures

Primary Outcomes (2)

• Mean changes in the BDI scores from baseline for those with a primary diagnosis of Depression

  3 Months

• Cumulative Abstinence Duration from baseline (Since discharge from the Residential Addiction treatment programme) for those with AUD.

  3 Months

Secondary Outcomes (4)

• Mean units of alcohol per drinking days for participants with AUD

  3 Months

• Mean Days to first drink for participants with AUD

  3 Months

• Number of hazardous drinking days from baseline for participants with AUD

  3 Months

• Health related Quality of Life will be measured using the EQ-5D-5L (Canadian version)

  3 Months

Other Outcomes (1)

• Frequency of health services utilization

  3 Months

Study Arms (2)

Supportive text message group

EXPERIMENTAL

Patients in all the intervention groups will receive twice daily supportive SMS text messages for 3 months .

Other: Supportive text messages

No supportive text message group

NO INTERVENTION

Patients in the control group will only receive a text message once every two weeks thanking them for participating in the study. The aim of this will be to help increase the retention rate for the study.

Interventions

Supportive text messages OTHER

Patients in all the intervention groups will receive twice daily supportive SMS text messages for 3 months. The messages will be tailored towards improving mood, compliance with medication or targeting abstinence from alcohol in accordance with the primary aims of our study. As far as possible, the majority of the text messages will reflect lessons patients usually learn during CBT and addiction counselling sessions.

Supportive text message group

Eligibility Criteria

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

You may qualify if:

• Persons aged over 18 years who are able to provide informed consent,
• Patient must have been assessed by a psychiatrist and fulfil the DSM-5 diagnostic criteria for Major Depressive Disorder or have completed the residential addiction treatment programme located at the Northern Addiction Treatment Centre and fulfil the DSM-5 diagnostic criteria for Alcohol Use Disorder.
• They must be familiar with or willing to learn how to receive text messages and will be available for follow-up.

You may not qualify if:

• Patients with Schizophrenia, Schizoaffective Disorder, Bipolar Disorder and other psychotic disorders. - -People who are living outside of regular cell phone connection areas

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Health services: collaborator

Study Sites (2)

Northern Lights Regional Health Centre

Fort McMurray, Alberta, Canada

Location

Northern Addiction Rehabilitation Centre

Grande Prairie, Alberta, Canada

Location

Related Publications (2)

• Agyapong VIO, Juhas M, Ohinmaa A, Omeje J, Mrklas K, Suen VYM, Dursun SM, Greenshaw AJ. Randomized controlled pilot trial of supportive text messages for patients with depression. BMC Psychiatry. 2017 Aug 2;17(1):286. doi: 10.1186/s12888-017-1448-2.

  PMID: 28768493 DERIVED

• Agyapong VI, Mrklas K, Suen VY, Rose MS, Jahn M, Gladue I, Kozak J, Leslie M, Dursun S, Ohinmaa A, Greenshaw A. 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. JMIR Res Protoc. 2015 May 15;4(2):e55. doi: 10.2196/resprot.4371.

  PMID: 25979786 DERIVED

MeSH Terms

Conditions

Depression; Alcoholism

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Vincent IO Agyapong, MD FRCPC

  Department of Psychiatry, University of Alberta

  PRINCIPAL INVESTIGATOR

• Serdar Dursun, PhD FRCPC

  Department of Psychiatry, University of Alberta

  STUDY DIRECTOR

• Andrew Greenshaw, PhD

  Department of Psychiatry, University of Alberta

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: December 24, 2014
• First Posted: December 30, 2014
• Study Start: July 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 8, 2016

Record last verified: 2016-08

Locations

CA (2)