Clinical trial NCT02404662: Trial of Supportive Text Messages for Patients With Alcohol Use Disorder and a Co-morbid Depression
Official title: Single Blind Randomised Trial of Supportive Text Messages for Patients With Alcohol Use Disorder and a Co-morbid Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dual Diagnosis
Keywords: Alcohol use disorder
Depression
Mood disorders
Bipolar disorder
Supportive text messages
Lead sponsor: St Patrick's Hospital, Ireland
Sponsor class: OTHER
Collaborators: name: University of Dublin, Trinity College
First posted: 2015-03-31
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Co-morbidity of alcohol use disorder (AUD) and mood disorders presents a great challenge to health systems and exacts a tremendous toll world-wide. Individuals with a dual diagnosis have more severe symptoms, greater disability and poor quality of life than those with either diagnosis alone, and pose a greater economic burden to society due to their higher use of treatment services. New, enhanced, efficient, innovative and cost effective treatment strategies aimed at reducing the burden that the disorders impose on the suffers and their families as well as the community and health systems are required. In a pilot trial of supportive text messages for patients with alcohol use disorders and co-morbid 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 cumulative abstinence duration than those who did not receive any supportive text messages.

This research seeks to extend the knowledge gained from the pilot trial. A randomised trial will be conducted on a larger sample size of patients with alcohol use disorder and a co-morbid depressive disorder (including bipolar depression) for an extended duration (6 months of supportive text messages and 1 year follow-up instead of 3 months text messages with 6 months follow-up in the pilot trial). It is hypothesised that patients receiving supportive text messages will report significantly greater cumulative abstinence duration as well as significantly less relapses, hospitalizations and mood symptoms than those not receiving such messages. It is anticipated that this technology intervention for relapse prevention will be acceptable to patients as well as cost effective.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Able to provide written, informed consent.
3. Mini-mental state examination (MMSE) score of ≥ 25
4. Patients who have a mobile phone, are familiar with SMS text messaging technology and are willing to take part in the study.

Exclusion Criteria:

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

Primary outcomes:
measure: Cumulative abstinence duration (CAD).
timeFrame: 12 months following discharge from the inpatient treatment programme.
measure: Changes in Beck's Depression Inventory (BDI) scores from baseline.
timeFrame: 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:
measure: Proportion of patients continuously abstinent from alcohol at 6 and 12 months.
timeFrame: 6 and 12 months post-discharge.
measure: Time to first drink.
timeFrame: 3, 6, 9 and 12 months post-discharge.
measure: Perception of patients in the intervention group about the usefulness of supportive text messages.
timeFrame: 6 months post-discharge
measure: Changes from baseline in scores on the modified global assessment of function (m-GAF) scale.
timeFrame: This assessment will be completed at baseline and then at 3, 6, 9 and 12 months.
measure: Changes from baseline in scores on the alcohol expectancy questionnaire (AEQ).
timeFrame: This scale will be administered at baseline and then at 3, 6, 9 and 12 months.
measure: Changes from baseline in scores on the obsessive compulsive drinking scale (OCDS).
timeFrame: This scale will be administered at baseline and then at 3, 6, 9 and 12 months.
measure: Changes from baseline in scores on the alcohol abstinence self-efficacy scale (AASES).
timeFrame: These scales will be administered at baseline and then at 3, 6, 9 and 12 months.
measure: Changes from baseline in scores on the perceived stress scale (PSS).
timeFrame: This scale will be administered at baseline and then at 3, 6, 9 and 12 months.
measure: Changes from baseline in scores on the young mania rating scale (YMRS).
timeFrame: This assessment will be completed at baseline and then at 3, 6, 9 and 12 months.
measure: Changes from baseline in blood measures of alcohol abuse.
timeFrame: Blood samples will be analysed at baseline, then at 3, 6, 9 and 12 months following discharge.
measure: Patient satisfaction with overall treatment protocol in both groups
timeFrame: 3, 6, 9 and 12 months
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: St. Patrick's University Hospital
Study officials:
affiliation: St Patrick's Hospital, Ireland
name: Conor Farren, PhD,MRCPsych
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.