Dr. Conor Farren

Summary

Project Abstract Co-morbidity of alcohol use disorders and mood disorders presents great challenge to health systems and exact a tremendous toll world-wide. Individuals with the dual disorder have more severe symptoms, greater disability and poor quality of life than individuals with only alcohol use disorder, and pose a greater economic burden to society due to their higher use of treatment services. We seek to develop a 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. In a pilot trial of supportive text messages for patients with alcohol use disorders and comorbid 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 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. We will conduct a randomised trial on a larger sample size of patients with an alcohol use disorders and a comorbid mood disorder (including bipolar depression) for an extended duration (Six months supportive text messages and 1 year follow-up instead of three months text messages with six months follow-up in the pilot trial). We hypothesis that patients receiving supportive text messages would report significantly greater cumulative abstinence duration as well as significantly less relapses, hospitalizations and mood symptoms than those not receiving such messages. The technology would also be acceptable to patients as well as cost effective.

Funding Agency

Health Research Board

Programme

Definitive Study (DIFA)

Project Type

Clinical Trial

Person Months

36

Summary

There is increasing evidence to suggest that mobile health (mHealth) applications can be a therapeutically and cost effective means of treating Alcohol Use Disorders (AUD) and problem drinking (Riper et al., 2011; Quanbeck, et al., 2014). Agyapong et al. (2012) found, for example, in a single-blind randomised controlled trial of twice daily text messages targeting depression and comorbid AUD, that those who received text messages had significantly lower depressive symptoms at three months follow-up than those who received treatment as usual, with a trend toward fewer drinking days in the text message group also. Similarly, Gustafson et al. (2014) found, in a multi-site non-blind randomised controlled trial involving alcohol dependant adults, that an integrated monitoring, information communication, and therapeutic support mHealth application led to significantly fewer risky drinking days for those in the mHealth group compared to the control group. mHealth applications may be particularly suited to treating AUD and problem drinking as they allow for real-time monitoring, therapeutic support, and positive reinforcement of recovery activity when and where this is needed, and in a convenient location and format. mHeatlh applications thus have the potential to allow for significantly greater utilisation of therapeutic resources than is traditional, and these resources will be considerably cheaper than the currently available therapeutic interventions as they are delivered through technology. Aims To conduct a non-blind controlled trial of U Control Drink to assess its effectiveness with an alcohol abusing and /or dependant CRI population. Techniques and Methodology (including any assessment measures) Participants Participants will be approximately 100 alcohol abusing and/or dependant service users referred to CRI. Assessment Instruments The Alcohol Use Disorders Identification Test (AUDIT) will be used to assess severity of alcohol abuse and dependence problems. A number of other clinically relevant indices such as number of logged drinks will be automatically collected by the U Control Drink application. Participants will additionally complete a brief usability questionnaire (BUQ) in relation to their experience of using the application. Method Following routine baseline assessment participants will be assigned to receive either treatment as usual (TAU) or TAU + U Control Drink (TAU+UCD). Group assignment will be based on alternate group allocation whereby participants will be alternately assigned to each group on a 1:1 basis. An appropriate healthcare professional will administer the AUDIT during routine baseline assessment (Time 1), and the AUDIT+BUQ at 3-month follow-up (Time 2). Participants allocated to the TAU+UCD group who score below 8 on the AUDIT will be offered access to UCD in addition to routine advice and eHealth treatment. Those scoring between 8 and 20 will be offered UCD in parallel with motivational enhancement therapy, and pharmacotherapy if appropriate. For participants scoring above 20, and who require inpatient detoxification, TAU+UCD will be offered in parallel to routine treatment post-discharge.

Funding Agency

Health Research Board

Programme

DIFA

Project Type

Clinical Trial

Summary

E-therapy is a developing area of medicine, and it is being increasing used to deliver effective results in a variety of health disorders, embracing a variety of technologies to improve accessibility and effective delivery of treatment to more people. Mental health issues, including addictive disorders, lend themselves to being treated via e-therapy probably more than any other of medicine. The treatment trial could have a TAU group, a TAU plus theyouturn group, delivered online. Economic benefit analysis could thus have a costing of each of the three groups, according to different costs of the interventions. There will also be a pre-clinical group, recruited online, or by advertisement, consisting of a study control group, a technology intervention group, and a technology intervention plus weekly online therapist group. The numbers are outlined in the attached study design. For each setting, and each language, there would be a need to adjust support mechanisms for that particular setting. For example text messaging support would have to be sent in the appropriate language, and with culturally sensitive messages. Chat rooms and personal feedback would have to be developed in a language appropriate and culturally appropriate manner. Each support technology would have to be tested in the appropriate setting, as different cultures are likely to gain benefit from different supports according to locally effective recovery principles. For example, text messaging support may prove effective in Germany, and chat - room and peer support may prove more effective in Spain. Thus the project divides itself into three components, in each of the five regions. Firstly each regional director would have to set up focus groups, and stakeholder feedback regarding the most appropriate balance of technologies for their own setting. This would be in the form of small group testing of service users, and utilisation of the feedback to make up a premium package for that country. Technology, initially developed for Ireland, would need to be translated into four other languages, and each component tested in the appropriate population. Upon completion of this alpha testing phase, a technological package for each region will be decided upon by each regional director, in conjunction with the project coordinator. Upon completion of each technology package, the clinical trials will be set up in each region. The clinical trials sizes will be determined by the best available clinical trial data to date, including from recent pharmacotherapy trials, as well as CBT trials, and online therapy trials, including that from the project coordinator. Recruitment will be from both post rehabilitation groups, as well as outpatient alone recruitment for the clinical trial; and from online advertising for the pre-clinical trial.

Funding Agency

EU

Programme

Horizon 2020 Project: PHC 26- 2014: Self management of health and disease: citizen engagement and mH

Project Type

Multisite clinical trial

Person Months

60

Summary

Application to Enterprise Ireland for administrative support for an Horizon 2020 application. This grant provided support for travel expenses for other members of the international consortium, support for an administrative company.

Funding Agency

EI

Programme

Small grant

Project Type

Clinical Trial

Person Months

12

Summary

Co-investigator, medical director of the protocol, Running a clinical trial of maintenance naltrexone for alcohol dependence, running 197 patients for a total of 9 months each over 6 years, with significant protocol development and manuscript writing input.

Funding Agency

National Institute on Alcoholism and Alcohol Abuse.

Programme

RO1

Project Type

Clinical Trial

Person Months

60