The Measurement of Mood Variability and Sustained Attention in Women With Alcohol Dependence.

October 10, 2006 updated by: University of Saskatchewan

The purpose of this study is to measure daily mood changes and to find out whether these mood changes are related to the ability to maintain attention on a task. Problems with mood are more common among women however, the association between symptoms of alcohol abuse and mood syndromes is inconsistent.

First we hypothesize that women with lifetime diagnoses of alcohol abuse will not demonstrate higher symptoms of anxiety, depression, neuroticism and mood variability than control groups. Second, that the severity of these symptoms will not correlate with performance on measures of sustained attention.

Study Overview

Status

Completed

Detailed Description

Epidemiological and clinical studies show an association between symptoms of anxiety and depression (mood) and alcohol abuse. However, the association between alcohol abuse and mood syndromes is inconsistent. One problem is that mood syndromes tend to be poorly defined. Also, researchers typically have relied on retrospective recall by patients to evaluate mood symptoms.

Some of this evidence is that:

  1. Most mood symptoms improve with withdrawal in inpatient alcoholism programs without specific treatment of the mood disorder.
  2. Family genetic studies have not shown cosegregation.
  3. Psychiatric treatment of mood syndromes does not decrease alcohol use.
  4. The self-treatment view has not been supported by controlled drinking studies.

To overcome this difficulty, we have recently developed a procedure to measure mood variability while it is occurring. We ask participants to rate their moods twice a day on a 10 cm straight line anchored by the terms "not at all" and "very much so" (a visual analogue scale) (VAS). There are 3 separate lines for "anxiety/tension", "sadness/low mood" and "high mood". We then compute a quantitative measure of variability the "mean squared successive difference statistic" (MSSD). Our earlier work found that this method identified greater mood variability in individuals with anxiety disorders as compared to individuals without anxiety disorders.

Our null hypotheses are:

1. That women with lifetime diagnoses of alcohol abuse will not demonstrate higher symptoms of anxiety, depression, neuroticism and mood variability than control groups and;

1a. That the severity of these symptoms will not correlate with performance on measures of sustained attention.

The MINI diagnostic interview will be used to derive DSM-IV diagnoses. This is a brief semi-structured diagnostic interview that we have used previously. We have not used an extensive interview schedule such as the SCID because we are not recruiting specific diagnostic groups.

Participants will be asked to complete 4 scales as validators of the diary visual analogue scales. These are:

  1. The Beck Depression Inventory (BDI-II). This is the most widely used self- completed depression questionnaire. It has 21 items, each has 4 choices.
  2. The Spielberger Trait-State Self-Evaluation Questionnaire (STAI-T). This is a 20 item- questionnaire, with answers on a 4-point scale. It is the most widely used trait anxiety inventory.
  3. The Mood Disorders Questionnaire. This is a recently developed but well researched questionnaire to measure high mood. Sixteen questions are in a yes/no format.
  4. 12 items from the Neuroticism Scale of the Eysenck Personality Inventory as modified by Kendler. These items are answered yes/no.

Participants will be females, aged 18-50 years with diagnoses of alcohol abuse. Exclusion criteria will be chronic medical, psychiatric or brain conditions that might affect mood variability or test performance. Comorbid drug abuse will not be reason for exclusion.

Only females are included in this study because

  1. The association between mood symptoms and substance abuse appears to be clearer in women (In men, other characteristics such as impulsivity and antisocial traits are more prominent).
  2. We already have data on mood variability in predominantly female normal control subjects from studies in the Department of Psychiatry at Royal University Hospital.

Participants will be tested in their 3rd and 4th weeks of the program, i.e. they will have been free of alcohol and illicit drug consumption for 3 weeks. Use of other medication will be noted but will not be an exclusion.

Study Type

Observational

Enrollment

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7J 2H6
        • Calder Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Females ages 18 to 50.
  • Diagnosed with alcohol abuse issues.

Exclusion Criteria:

  • Males (any age).
  • Chronic medical (organic) or psychiatric conditions that might affect mood variability or test performance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Rudy Bowen, MD, University of Saskatchewan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Study Completion

June 1, 2004

Study Registration Dates

First Submitted

September 27, 2005

First Submitted That Met QC Criteria

September 28, 2005

First Posted (Estimate)

September 30, 2005

Study Record Updates

Last Update Posted (Estimate)

October 11, 2006

Last Update Submitted That Met QC Criteria

October 10, 2006

Last Verified

September 1, 2005

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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