Understanding Treatment Adherence Among Individuals With Bipolar Disorder

NCT00183495 | Completed

• 2 other identifiers: K23MH065599-01DAHBR 9K-TA
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bipolar Disorder

Keywords

Depression, Bipolar; Manic-Depressive Psychosis

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with bipolar disorder receiving treatment at a Community Mental Health Clinic in Northeast Ohio.

You may qualify if:

• 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

You may not qualify if:

• Unable/unwilling to participate in psychiatric interviews

Sponsors & Collaborators

• Case Western Reserve University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Northeast Ohio Health Services

Beachwood, Ohio, 44122, United States

Location

Related Publications (4)

• 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: 10.1016/j.comppsych.2008.06.008. Epub 2008 Aug 23.

  PMID: 19216885 RESULT

• Smilowitz S, Aftab A, Aebi M, Levin J, Tatsuoka C, Sajatovic M. Age-Related Differences in Medication Adherence, Symptoms, and Stigma in Poorly Adherent Adults With Bipolar Disorder. J Geriatr Psychiatry Neurol. 2020 Sep;33(5):250-255. doi: 10.1177/0891988719874116. Epub 2019 Sep 22.

  PMID: 31542988 DERIVED

• Sajatovic M, Tatsuoka C, Cassidy KA, Klein PJ, Fuentes-Casiano E, Cage J, Aebi ME, Ramirez LF, Blixen C, Perzynski AT, Bauer MS, Safren SA, Levin JB. A 6-Month, Prospective, Randomized Controlled Trial of Customized Adherence Enhancement Versus Bipolar-Specific Educational Control in Poorly Adherent Individuals With Bipolar Disorder. J Clin Psychiatry. 2018 Sep 25;79(6):17m12036. doi: 10.4088/JCP.17m12036.

  PMID: 30256551 DERIVED

• Sajatovic M, Micula-Gondek W, Tatsuoka C, Bialko C. The relationship of gender and gender identity to treatment adherence among individuals with bipolar disorder. Gend Med. 2011 Aug;8(4):261-8. doi: 10.1016/j.genm.2011.06.002. Epub 2011 Jul 16.

  PMID: 21763217 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Martha Sajatovic, MD

  Case Western Reserve University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: March 1, 2004
• Primary Completion: March 1, 2007
• Study Completion: August 1, 2007
• Last Updated: July 31, 2019

Record last verified: 2019-07

Locations

US (1)