Understanding Treatment Adherence Among Individuals With Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

Determinants and Manifestation of Illness Behavior in Promoting Treatment Adherence Among Individuals With Bipolar Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00183495
• Other study ID #: K23MH065599-01
• Secondary ID: K23MH065599-01DA
• Status: Completed
• Start date: March 2004
• Est. completion date: August 2007

Study information

• Verified date: July 2019
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will examine how various factors, such as psychiatric symptoms, gender, social support, substance use, and attitudes toward medication, affect treatment adherence in individuals with bipolar disorder.

Description:

Bipolar Disorder (BPD), also known as manic-depressive illness, is a disorder that causes frequent shifts in an individual's mood, energy, and ability to function. An individual with BPD may go through periods of mania, which are characterized by increased energy, irritability, and an excessively "high" euphoric mood. The manic periods are followed by periods of depression, which are characterized by decreased energy, feelings of hopelessness, and anxiety. BPD is a persistent and severe mental illness with a high suicide rate; it must be strictly managed through medication and therapy. Many BPD medications have been developed recently; however, there are still many individuals who do not respond well to medication treatment. Research has shown that the way individuals experience illness has an effect on their response to medication. The purpose of this study is to gain insight into how individuals with BPD perceive and respond to medication treatment. Factors such as gender, degree of social support, drug and alcohol usage, and attitudes towards medication will be evaluated to understand how they affect medication and treatment adherence.

This 6-month study will consist of 3 interviews. Each interview will last approximately 2 and ½ hours and will include numerous standardized psychological questionnaires. The questionnaires will assess participants' attitudes toward BPD treatment; psychiatric illness severity, including symptoms of mania and depression; level of addiction to alcohol and drugs; availability of social support resources; and medication adherence.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: August 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of bipolar disorder type I for at least two years prior to study entry

• Has experienced an index depressive episode

• Received treatment with medication to stabilize mood for at least 6 months prior to study entry

• Able to participate in psychiatric interviews

• Lives in the Northeast Ohio area and is a patient at either Northeast Ohio Health Services or The Mood Disorders Clinic at University Hospitals of Cleveland

Exclusion Criteria:

• Unable/unwilling to participate in psychiatric interviews

Related Conditions & MeSH terms

• Bipolar Disorder

Locations

Country	Name	City	State
United States	Northeast Ohio Health Services	Beachwood	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Western Reserve University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Sajatovic M, Ignacio RV, West JA, Cassidy KA, Safavi R, Kilbourne AM, Blow FC. Predictors of nonadherence among individuals with bipolar disorder receiving treatment in a community mental health clinic. Compr Psychiatry. 2009 Mar-Apr;50(2):100-7. doi: 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attitudes toward Mood Stabilizers Questionnaire (AMSQ)	The AMSQ is a 19-item scale which is a modification of the Lithium Attitudes Questionnaire (LAQ) that evaluates an individual's attitude toward mood-stabilizing medication. The questions are in a yes/no format. The AMSQ has 7 subscales that represent key attitudinal domains with respect to adherence, as follows: 1. opposition to prophylaxis, 2. denial of therapeutic effectiveness, 3. fear of adverse effects, 4. difficulty with medication routines, 5. denial of illness severity, 6. negative attitude toward drugs in general, and 7. lack of information about mood stabilizers. Total scores range from 0 to 19. Higher scores on the total and each subscale represent more negative attitudes toward mood stabilizers.	Change from Baseline to 6 month visit
Primary	Brief Psychiatric Rating Scale (BPRS)	The BPRS measures levels of mania. There are 24 items, scored on a 7-point scale ranging from 0 to 6. Total scores range from 0 to 42, with higher scores indicating higher levels of mania.	Change from Baseline to 6 month visit
Primary	Addiction Severity Index (ASI)	A portion of the standardized instrument measuring level of addiction to alcohol and drugs. Items 1-14 of the Alcohol/Drug index were used. The ASI evaluated both lifetime and past-30 day use of a wide variety of commonly abused substances. Each question is divided by its maximum answer value and by the total number of questions in the composite. These individual results are then summed.; The six questions (A-F) that make up the alcohol composite score is determined by: A/180 + B/180 + C/180 + D/24 + E/24 + log F/44.; The 13 questions (A-M) that make up the drug composite score is determined by: A/390 + B/390 + C/390 + D/390 + E/390 + F/390 + G/390 + H/390 + I/390 + J/390 + K/390 + L/52 + M/52.	Change from Baseline to 6 month visit
Primary	Interpersonal Suppose Evaluation List (ISEL)	The ISEL is a 40-item self-report questionnaire that was developed to assess availability of social support resources. A total index is composed of four subscales: tangible assistance (material aid), appraisal (availability of someone to talk to about life's problems), self-esteem (positive appraisal of self from others and positive comparison when comparing one's self with others) and belonging (people with whom one can do things). Response for each item is coded on a 4-point Likert scale ranging from definitely false to definitely true. Total scores range from 0 to 120, with higher scores indicating a higher availability of perceived social support.	Change from Baseline to 6 month visit
Primary	Tablets Routine Questionnaire (TRQ)	The TRQ evaluates adherence to medications via a brief self-report instrument that has been validated in populations with bipolar disorder medication adherence. The TRQ identifies nonadherent individuals, defined as those who miss 30% or more of their medication in the last week or month. Total scores are represented as a percentage and range from 0 to 100, with higher scores indicating a greater level of nonadherence (higher scores indicate worse adherence to medications).	Change from Baseline to 6 month visit
Primary	Hamilton Rating Scale for Depression (HAM-D)	The HAM-D measures form lists 21 items, the scoring is based on the first 17. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. Total scores range from 0-52, with higher scores indicating worse depression. The categories are as follows: 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score is 52.	Change from Baseline to 6 month visit