Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00230425
Status:
COMPLETED
Last Update Posted:
2006-10-11
First Post:
2005-09-27
Brief Title:
The Measurement of Mood Variability and Sustained Attention in Women With Alcohol Dependence
Sponsor:
University of Saskatchewan
Organization:
University of Saskatchewan
Study Overview
Official Title:
The Measurement of Mood Variability and Sustained Attention in Women With Alcohol Dependence
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
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 anxietytension sadnesslow 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 yesno format
4 12 items from the Neuroticism Scale of the Eysenck Personality Inventory as modified by Kendler These items are answered yesno
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 ie 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
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 anxietytension sadnesslow 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 yesno format
4 12 items from the Neuroticism Scale of the Eysenck Personality Inventory as modified by Kendler These items are answered yesno
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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None