Alcohol AbuseNCT00230425
The Measurement of Mood Variability and Sustained Attention in Women With Alcohol Dependence.
An observational study of Alcohol Abuse and Anxiety Disorders, run by University of Saskatchewan at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Alcohol Abuse, Anxiety Disorders, Mood Disorders
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2003to Jun 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females ages 18 to 50.
- Diagnosed with alcohol abuse issues.
Who cannot join
- Males (any age).
- Chronic medical (organic) or psychiatric conditions that might affect mood variability or test performance.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- Most mood symptoms improve with withdrawal in inpatient alcoholism programs without specific treatment of the mood disorder.
- Family genetic studies have not shown cosegregation.
- Psychiatric treatment of mood syndromes does not decrease alcohol use.
- 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:
- 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:
- The Beck Depression Inventory (BDI-II). This is the most widely used self- completed depression questionnaire. It has 21 items, each has 4 choices.
- 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.
- 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.
- 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
- 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).
- 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.
- Conditions
- Alcohol Abuse, Anxiety Disorders, Mood Disorders
- Keywords
- Alcohol Abuse, Anxiety Disorders, Mood Disorders
- Medical subject headings
- Alcoholism, Anxiety Disorders, Mood Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2005 (estimated)
- Study startFeb 2003
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Saskatoon Health Region
- Investigators
- Rudy Bowen, MD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00230425
- Sponsor's protocol ID
- BSC 02-760
- Status last verified
- Sep 2005
- First submitted
- 27 Sep 2005
- Last updated
- 11 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Measurement of Mood Variability and Sustained Attention in Women With Alcohol Dependence.
- ClinicalTrials.gov ID
- NCT00230425
- Acronym / sponsor ID
- BSC 02-760
- Conditions
- Alcohol Abuse, Anxiety Disorders, Mood Disorders
- Keywords
- Alcohol Abuse, Anxiety Disorders, Mood Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Saskatoon Health Region
- Study start
- Feb 2003
- Study completion
- Jun 2004
- First posted
- 30 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Most mood symptoms improve with withdrawal in inpatient alcoholism programs without specific treatment of the mood disorder.
- Family genetic studies have not shown cosegregation.
- Psychiatric treatment of mood syndromes does not decrease alcohol use.
- 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:
- 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:
- The Beck Depression Inventory (BDI-II). This is the most widely used self- completed depression questionnaire. It has 21 items, each has 4 choices.
- 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.
- 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.
- 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
- 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).
- 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 design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Females ages 18 to 50.
- Diagnosed with alcohol abuse issues.
Key exclusion criteria (2 listed)
- Males (any age).
- Chronic medical (organic) or psychiatric conditions that might affect mood variability or test performance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rudy Bowen, MD principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Abuse and Anxiety Disorders, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2006.