Trial of Supportive Text Messages for Patients With Alcohol Use Disorder and a Co-morbid Depression

NCT02404662 | Unknown DMC

• 1 other identifier: HRA-POR-2014-598
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

Most patients who present with problem drinking also present with mood problems. Problem drinking and mood problems co-occurring together in individuals lead them to have more severe symptoms, greater disability and poorer quality of life than individuals with only problem drinking, and they pose a greater economic burden to society due to their higher use of health services. This study aims to assess the efficacy of a new, innovative and cost effective treatment strategy aimed at reducing the burden that these co-occurring conditions impose on the suffers and their families as well as the community and health systems. In a recent pilot study of supportive text messages for patients with problem drinking and co-occurring depression, the investigators 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 to finding 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. This study seeks to extend the knowledge gained from the pilot study. A larger group of patients with alcohol use disorder and a depressive disorder will be randomly assigned to two groups. One group will receive supportive text messages for six months duration whilst the other group will receive no supportive text messages. The patients will be followed up at 3, 6, 9 and 12 months to determine which of the two groups have less alcohol and mood problems. It is anticipated that patients receiving supportive text messages will report significantly greater alcohol free days as well as significantly less relapses, hospitalizations and mood symptoms than those not receiving such messages.

Conditions

Dual Diagnosis

Keywords

Alcohol use disorder; Depression; Mood disorders; Bipolar disorder; Supportive text messages

Outcome Measures

Primary Outcomes (2)

• Cumulative abstinence duration (CAD).

  CAD will be assessed using the timeline to follow-back (TLFB). This will be used to record the quantity of alcohol consumed and number of drinking days.

  12 months following discharge from the inpatient treatment programme.

• Changes in Beck's Depression Inventory (BDI) scores from baseline.

  The BDI is a self-administered questionnaire widely used to assess depressive symptoms. It takes approximately 5 minutes to complete.

  BDI will be administered at baseline (during the in-patient treatment programme for dual diagnosis), and then at 3, 6, 9 and 12 months post-discharge from hospital.

Secondary Outcomes (11)

• Proportion of patients continuously abstinent from alcohol at 6 and 12 months.

  6 and 12 months post-discharge.

• Time to first drink.

  3, 6, 9 and 12 months post-discharge.

• Perception of patients in the intervention group about the usefulness of supportive text messages.

  6 months post-discharge

• Changes from baseline in scores on the modified global assessment of function (m-GAF) scale.

  This assessment will be completed at baseline and then at 3, 6, 9 and 12 months.

• Changes from baseline in scores on the alcohol expectancy questionnaire (AEQ).

  This scale will be administered at baseline and then at 3, 6, 9 and 12 months.

Study Arms (2)

Supportive text messages intervention

EXPERIMENTAL

Patients in the intervention group will receive twice daily supportive text messages to their mobile phone for 6 months following discharge from a 4-week in-patient dual diagnosis treatment programme. The messages will be sent by a computer programme at 10am and 7pm each day and will be set up and monitored by the research worker who will not participate in follow-up assessments. They will receive a fortnightly text message thanking them for participating in the study, and a brief phone call every 2 weeks to ensure that they are still using their phone and that they have received some messages. The intervention group will also receive treatment as usual, i.e. any follow-up after-care that they chose to participate in and regular AA/Lifering meetings.

Other: Supportive text messages intervention

Control group

ACTIVE COMPARATOR

Patients in the control group will receive a fortnightly text message thanking them for participating in the study, and a brief phone call every 2 weeks to ensure that they are still using their phone and that they have received some messages. The control group will also receive treatment as usual, i.e. any follow-up after-care that they chose to participate in and regular AA/Lifering meetings.

Other: Control group

Interventions

Supportive text messages intervention OTHER

The supportive text messages are based on existing aphorisms in the recovery literature. Each day patients will receive one message targeting mood and another message targeting abstinence from alcohol in accordance with the primary aims of our study. An example text message aimed at improving mood is: "Monitor changes in your mood; develop a list of personal warning signs." An example message targeting abstinence is: "Keep Sobriety as a number one priority and you will reach your goals. None of the messages will be repeated. The messages will be sent in the morning and evening, with the theme (mood/alcohol) of the messages pseudo-randomised according to delivery time, so that no more than three successive days will have the same theme sent at the same time slot.

Supportive text messages intervention

Control group OTHER

The control group will receive treatment as usual, as well as fortnightly thank you text messages and calls to ensure that they are still using their phone.

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who meet the criteria for both alcohol dependency syndrome/alcohol abuse and either major depressive disorder or bipolar disorder according to the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID) and are enrolled on the in-patient dual diagnosis or addiction treatment programmes in St. Patrick's University Hospital.
• Able to provide written, informed consent.
• Mini-mental state examination (MMSE) score of ≥ 25
• Patients who have a mobile phone, are familiar with SMS text messaging technology and are willing to take part in the study.

You may not qualify if:

• Patients who do not consent to take part in the study.
• Patients who do not have a mobile phone or are unable to use the mobile text message technology.
• Patients who would be unavailable for follow-up during the study period

Sponsors & Collaborators

• St Patrick's Hospital, Ireland: lead
• University of Dublin, Trinity College: collaborator

Study Sites (1)

St. Patrick's University Hospital

Dublin, Dublin 8, Ireland

Location

Related Publications (4)

• Agyapong VI, Ahern S, McLoughlin DM, Farren CK. Supportive text messaging for depression and comorbid alcohol use disorder: single-blind randomised trial. J Affect Disord. 2012 Dec 10;141(2-3):168-76. doi: 10.1016/j.jad.2012.02.040. Epub 2012 Mar 29.

  PMID: 22464008 BACKGROUND

• Agyapong VI, McLoughlin DM, Farren CK. Six-months outcomes of a randomised trial of supportive text messaging for depression and comorbid alcohol use disorder. J Affect Disord. 2013 Oct;151(1):100-4. doi: 10.1016/j.jad.2013.05.058. Epub 2013 Jun 22.

  PMID: 23800443 BACKGROUND

• Agyapong VI, Milnes J, McLoughlin DM, Farren CK. Perception of patients with alcohol use disorder and comorbid depression about the usefulness of supportive text messages. Technol Health Care. 2013;21(1):31-9. doi: 10.3233/THC-120707.

  PMID: 23358057 BACKGROUND

• Hartnett D, Murphy E, Kehoe E, Agyapong V, McLoughlin DM, Farren C. Supportive text messages for patients with alcohol use disorder and a comorbid depression: a protocol for a single-blind randomised controlled aftercare trial. BMJ Open. 2017 May 29;7(5):e013587. doi: 10.1136/bmjopen-2016-013587.

  PMID: 28554910 DERIVED

MeSH Terms

Conditions

Alcoholism; Depression; Mood Disorders; Bipolar Disorder

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Conor Farren, PhD,MRCPsych

  St Patrick's Hospital, Ireland

  PRINCIPAL INVESTIGATOR

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: Associate Clinical Professor, Trinity College Dublin; Consultant Psychiatrist, St Patrick's University Hospital

Study Record Dates

• First Submitted: March 19, 2015
• First Posted: March 31, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: September 1, 2018
• Last Updated: October 5, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)