Understanding Treatment Adherence Among Individuals With Rapid Cycling Bipolar Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00183703
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : March 23, 2018
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Martha Sajatovic, MD, Case Western Reserve University

Brief Summary:
This study will examine how various factors, such as psychiatric symptoms, gender, quality of life, and attitudes toward medication, affect treatment adherence in individuals with rapid cycling bipolar disorder.

Condition or disease
Bipolar Disorder

Detailed 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. Rapid cycling bipolar disorder (RCBPD) is a type of BPD in which the individual experiences four or more episodes of mania and depression per year. The rapid shift between the manic and depressive episodes makes it imperative that individuals with RCBPD strictly manage their illness with medication. 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 RCBPD 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 study will consist of 1 visit, which will last approximately 2 and ½ hours and will include an anthropological interview and numerous standardized psychological questionnaires. The interview and questionnaires will assess participants' attitudes toward BPD treatment; psychiatric illness severity, including symptoms of mania and depression; expectations regarding recovery, stigma, and quality of life; and medication adherence.

Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Rapid Cycling Bipolar Disorder (RCBPD), Subjective Illness Experience and Gender
Study Start Date : July 2004
Actual Primary Completion Date : November 2006
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources

Qualitative Interview
Participants with rapid cycling bipolar disorder (RCBPD)

Primary Outcome Measures :
  1. The Subjective Experience of Medication Interview (SEMI) [ Time Frame: Single visit ]
    The Subjective Experience of Medication Interview (SEMI) is a qualitative, semi-structured assessment of subjective experience of mental illness, which requires approximately 60-120 minutes to administer. Illness experience domains assessed include illness attitudes, attributions and behaviors, social relations, treatment history and medication experience, self-medication, quality of life, stigma, culture/ethnicity, and health care logistics. The SEMI has been modified for use in populations with Bipolar Disorder.

Secondary Outcome Measures :
  1. Hamilton Depression Rating Scale (HAMD) [ Time Frame: Single visit ]
    A rater administered rating to scale to measure symptoms of depression, and is the most commonly utilized rating scale to assess depressive symptoms in bipolar depression clinical studies.

  2. Clinical Global Impression (CGI) [ Time Frame: Single visit ]
    Global illness severity is measured with the Clinical Global Impressions (CGI), a widely used scale which evaluates illness severity on a 1 to 7 point continuum. Severity of illness ratings on the CGI have reported reliability scores ranging from 0.66-0.41.

  3. Insight and Treatment Attitudes Questionnaire (ITAQ) [ Time Frame: Single visit ]
    An 11-item rating scale to evaluate patient recognition of illness and need for treatment in psychiatric illness. Each ITAQ item is scored on a 0 to 2 scale (0 = no insight, 2 = good insight), and the scale has high interrater reliability (r=0.82, p<.001) (McEvoy 1981). Construct validity, checked by correlating scores with an open interview is also good (r=.85, p<.001).

  4. Illness Behavior Questionnaire (IBQ) [ Time Frame: Single visit ]
    A 62-item instrument designed to measure a respondent's attitudes, ideas, affects and attributions in relation to illness. The IBQ is a self-reported scale, in which the respondent answers "yes" or "no" to each question regarding illness experience and subjective response. There are seven major subscales derived through factor analysis. The IBQ has very good stability, with one-to-twelve week test-retest correlations ranging from .67-.85 for the subscales. It has good face and content validity.

  5. Attitude Towards Mood Stabilizers Questionnaire (AMSQ) [ Time Frame: Single visit ]
    A modification of the Lithium Attitudes Questionnaire (Harvey 1991) which evaluates an individual's attitudes towards mood stabilizing medication (Adams and Scott 2000). The AMSQ comprises 19 items grouped into 7 subscales: general opposition to prophylaxis (4 items), denial of illness severity (3 items), negative attitudes toward drugs in general (3 items), and lack of information about mood stabilizers (1 item). Higher scores on each subscale represent more negative attitudes toward mood stabilizers. Reliability for the 19 items ranges from 57.6 % to 96.9%.

  6. Multidimensional Health Locus of Control Scale (MHLC) [ Time Frame: Single visit ]
    An 18-item instrument that measures three dimensions of locus of control of reinforcement as it pertains to health (internal, IHLC: external-chance, CHLC: and external powerful others, PHLC). Scoring is from 6-36 with higher scores indicating stronger beliefs. The internal consistency reliability using Cronbach's alpha ranges from .67 to .77 for the three dimensions, and the measure has fairly good criterion validity (Wallston 1978).

  7. Treatment Adherence [ Time Frame: Single visit ]
    Treatment adherence will be evaluated in the following three ways: 1) The primary measure will be the Tablet Routines Questionnaire (TRQ, Peet 1991) which is a validated assessment of adherence among individuals with bipolar disorders (Scott 2002, Peet 1991), 2) Blood level of mood stabilizing and antipsychotic medications will be identified from the patient record. This has been identified as a standard of care in numerous guidelines for the treatment of bipolar disorder (American Psychiatric Association 2000, Goldberg 2000). 3) Adherence with clinic visits for the previous three month time period will be calculated as a percentage.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The population includes 20 individuals receiving treatment at an academic medical center and 20 individuals seeking treatment at a community mental health clinic.

Inclusion Criteria:

  • Clinical diagnosis of rapid cycling variant of bipolar disorder type I; diagnosed 2 to 20 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00183703

United States, Ohio
Northeast Ohio Health Services
Beachwood, Ohio, United States, 44122
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Case Western Reserve University
National Institute of Mental Health (NIMH)
Principal Investigator: Martha Sajatovic, MD Case Western Reserve University School of Medicine

Publications of Results:
Responsible Party: Martha Sajatovic, MD, Professor of Psychiatry and of Neurology, Case Western Reserve University Identifier: NCT00183703     History of Changes
Other Study ID Numbers: K23MH065599-02 ( U.S. NIH Grant/Contract )
K23MH065599-02 ( U.S. NIH Grant/Contract )
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018

Keywords provided by Martha Sajatovic, MD, Case Western Reserve University:
Depression, Bipolar
Manic-Depressive Psychosis

Additional relevant MeSH terms:
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders