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

Dual Diagnosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02404662
• Other study ID #: HRA-POR-2014-598
• Status: Active, not recruiting
• Phase: N/A
• First received: March 19, 2015
• Last updated: October 4, 2017
• Start date: March 2015
• Est. completion date: September 2018

Study information

• Verified date: May 2017
• Source: St Patrick's Hospital, Ireland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 107
• Est. completion date: September 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Depression
• Dual Diagnosis

Intervention

Other:
• Supportive text messages intervention
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.
• Control group
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.

Locations

Country	Name	City	State
Ireland	St. Patrick's University Hospital	Dublin

Sponsors (2)

Lead Sponsor	Collaborator
St Patrick's Hospital, Ireland	University of Dublin, Trinity College

Country where clinical trial is conducted

Ireland, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Proportion of patients continuously abstinent from alcohol at 6 and 12 months.	Continuous abstinence will be assessed using the TLFB.	6 and 12 months post-discharge.
Secondary	Time to first drink.	The time between the patient's discharge from hospital and their first drink, if any, during the study, will be measured using the TLFB.	3, 6, 9 and 12 months post-discharge.
Secondary	Perception of patients in the intervention group about the usefulness of supportive text messages.	Patient perceptions about the usefulness of the intervention will be assessed at the end of the intervention period in an interview.	6 months post-discharge
Secondary	Changes from baseline in scores on the modified global assessment of function (m-GAF) scale.	The m-GAF will be used to measure subjective changes in the social, occupational and psychological functioning of the patients over the course of the study.	This assessment will be completed at baseline and then at 3, 6, 9 and 12 months.
Secondary	Changes from baseline in scores on the alcohol expectancy questionnaire (AEQ).	This scale will measure changes in attitudes towards alcohol over the course of the study.	This scale will be administered at baseline and then at 3, 6, 9 and 12 months.
Secondary	Changes from baseline in scores on the obsessive compulsive drinking scale (OCDS).	This scale will measure changes in obsessive compulsive thoughts about alcohol over the 12 months of the study.	This scale will be administered at baseline and then at 3, 6, 9 and 12 months.
Secondary	Changes from baseline in scores on the alcohol abstinence self-efficacy scale (AASES).	This scale will measure changes in feelings of self-efficacy and personal control around drinking over the 12 months of the study.	These scales will be administered at baseline and then at 3, 6, 9 and 12 months.
Secondary	Changes from baseline in scores on the perceived stress scale (PSS).	This scale will measure changes in perceived stress over the 12 months of the study. This construct is closely related to resilience, which is a positive predictor of recovery in addiction.	This scale will be administered at baseline and then at 3, 6, 9 and 12 months.
Secondary	Changes from baseline in scores on the young mania rating scale (YMRS).	This subjective rating scale assesses the level of mania in patients with bipolar disorder (BP). It will be used to track changes in the manic symptoms of the BP patients over the 12 months of the study.	This assessment will be completed at baseline and then at 3, 6, 9 and 12 months.
Secondary	Changes from baseline in blood measures of alcohol abuse.	Three blood measures suggestive of alcohol abuse will be taken to corroborate self-report measures of alcohol intake or abstinence from the TLFB- gamma glutamyl transferase (GGT), alkaline phosphatase (AST) and mean corpuscular volume (MCV).	Blood samples will be analysed at baseline, then at 3, 6, 9 and 12 months following discharge.
Secondary	Patient satisfaction with overall treatment protocol in both groups	Patient satisfaction will be assessed using an adaptation of a treatment evaluation questionnaire.	3, 6, 9 and 12 months