Understanding Treatment Adherence Among Individuals With Rapid Cycling Bipolar Disorder
4 febbraio 2019 aggiornato da: Martha Sajatovic, MD, Case Western Reserve University
Rapid Cycling Bipolar Disorder (RCBPD), Subjective Illness Experience and Gender
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.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Osservativo
Iscrizione (Effettivo)
40
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Ohio
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Beachwood, Ohio, Stati Uniti, 44122
- Northeast Ohio Health Services
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Cleveland, Ohio, Stati Uniti, 44106
- University Hospitals of Cleveland
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
The population includes 20 individuals receiving treatment at an academic medical center and 20 individuals seeking treatment at a community mental health clinic.
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Qualitative Interview
Participants with rapid cycling bipolar disorder (RCBPD)
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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The Subjective Experience of Medication Interview (SEMI)
Lasso di tempo: Baseline
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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.
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Baseline
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Hamilton Depression Rating Scale (HAMD)
Lasso di tempo: Baseline
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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.
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Baseline
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Clinical Global Impression (CGI)
Lasso di tempo: Baseline
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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.
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Baseline
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Insight and Treatment Attitudes Questionnaire (ITAQ)
Lasso di tempo: Baseline
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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).
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Baseline
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Illness Behavior Questionnaire (IBQ)
Lasso di tempo: Baseline
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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.
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Baseline
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Attitude Towards Mood Stabilizers Questionnaire (AMSQ)
Lasso di tempo: Baseline
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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%.
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Baseline
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Multidimensional Health Locus of Control Scale (MHLC)
Lasso di tempo: Baseline
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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).
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Baseline
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Treatment Adherence
Lasso di tempo: Baseline
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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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Baseline
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Sajatovic M, Jenkins JH, Cassidy KA, Muzina DJ. Medication treatment perceptions, concerns and expectations among depressed individuals with Type I Bipolar Disorder. J Affect Disord. 2009 Jun;115(3):360-6. doi: 10.1016/j.jad.2008.10.002. Epub 2008 Nov 8.
- Sajatovic M, Jenkins JH, Safavi R, West JA, Cassidy KA, Meyer WJ, Calabrese JR. Personal and societal construction of illness among individuals with rapid-cycling bipolar disorder: a life-trajectory perspective. Am J Geriatr Psychiatry. 2008 Sep;16(9):718-26. doi: 10.1097/JGP.0b013e3180488346. Epub 2007 Dec 10.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 luglio 2004
Completamento primario (Effettivo)
1 novembre 2006
Completamento dello studio (Effettivo)
1 agosto 2007
Date di iscrizione allo studio
Primo inviato
14 settembre 2005
Primo inviato che soddisfa i criteri di controllo qualità
14 settembre 2005
Primo Inserito (Stima)
16 settembre 2005
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
6 febbraio 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
4 febbraio 2019
Ultimo verificato
1 febbraio 2019
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- K23MH065599-02 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .