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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02404662
• Date of registration: 19/03/2015
• Prospective Registration: No
• Primary sponsor: St Patrick's Hospital, Ireland
• Public title: Trial of Supportive Text Messages for Patients With Alcohol Use Disorder and a Co-morbid Depression
• Scientific title: Single Blind Randomised Trial of Supportive Text Messages for Patients With Alcohol Use Disorder and a Co-morbid Depression
• Date of first enrolment: March 2015
• Target sample size: 107
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02404662
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Ireland

Contacts

• Name: Conor Farren, PhD,MRCPsych
• Affiliation: St Patrick's Hospital, Ireland

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Dual Diagnosis

Intervention(s)

Other: Control group

Other: Supportive text messages intervention

Primary Outcome(s)

Changes in Beck's Depression Inventory (BDI) scores from baseline. [Time Frame: 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.]

Cumulative abstinence duration (CAD). [Time Frame: 12 months following discharge from the inpatient treatment programme.]

Secondary Outcome(s)

Changes from baseline in scores on the alcohol abstinence self-efficacy scale (AASES). [Time Frame: These scales will be administered at baseline and then at 3, 6, 9 and 12 months.]

Changes from baseline in scores on the obsessive compulsive drinking scale (OCDS). [Time Frame: This scale will be administered at baseline and then at 3, 6, 9 and 12 months.]

Perception of patients in the intervention group about the usefulness of supportive text messages. [Time Frame: 6 months post-discharge]

Proportion of patients continuously abstinent from alcohol at 6 and 12 months. [Time Frame: 6 and 12 months post-discharge.]

Time to first drink. [Time Frame: 3, 6, 9 and 12 months post-discharge.]

Changes from baseline in scores on the young mania rating scale (YMRS). [Time Frame: This assessment will be completed at baseline and then at 3, 6, 9 and 12 months.]

Changes from baseline in blood measures of alcohol abuse. [Time Frame: Blood samples will be analysed at baseline, then at 3, 6, 9 and 12 months following discharge.]

Changes from baseline in scores on the modified global assessment of function (m-GAF) scale. [Time Frame: 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). [Time Frame: This scale will be administered at baseline and then at 3, 6, 9 and 12 months.]

Changes from baseline in scores on the perceived stress scale (PSS). [Time Frame: This scale will be administered at baseline and then at 3, 6, 9 and 12 months.]

Patient satisfaction with overall treatment protocol in both groups [Time Frame: 3, 6, 9 and 12 months]

Secondary ID(s)

HRA-POR-2014-598

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Dublin, Trinity College