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The Effect of a Theory Based Educational Intervention on Medication Adherence to and Removes of Related Barriers in Patients With Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT02241863
Recruitment Status : Completed
First Posted : September 16, 2014
Last Update Posted : January 5, 2016
Sponsor:
Information provided by (Responsible Party):
Amir H Pakpour, Qazvin University Of Medical Sciences

Brief Summary:
Despite an increasing pharmacopoeia of effective medications for the treatment of bipolar disorder, patient outcomes continue to be impacted by treatment adherence. Non-adherence to treatments is also a major obstacle in translating efficacy in research settings into effectiveness in clinical practice. Non-adherence with bipolar disorder (BD) medication treatment dramatically worsens outcomes. Reasons for non-adherence among individuals with BD are multi-dimensional, and it has been suggested that a multifaceted intervention will be more effective. The study is aimed to assess the effectiveness of a multifaceted intervention on enhancing medications adherence in patients with bipolar disorders.

Condition or disease Intervention/treatment Phase
Patients With Bipolar Disorders Behavioral: Multifaceted intervention Behavioral: Routine counseling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2014
Actual Primary Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Experimental: Multifaceted intervention
Patients, their caregivers and family members will received the educational and motivational interventions
Behavioral: Multifaceted intervention
Supportive intervention: care giver, health care providers, and patient's family members (including disease knowledge, treatment t of the disease, medication problems or adverse effects, the importance of medication adherence, supervision taking medications by the patients as prescribed). patient education: about the disease and treatment, consuming regularly the pills motivational intervening, self-monitoring planning. Patients will attend in five motivational interviewing sessions regularly to facilitating and engaging intrinsic motivation within the patients in order to change medication adherence behavior.

Active Comparator: Active Comparator
Usual Care The usual care group received routine counseling performed by the psychiatrist and nurses.
Behavioral: Routine counseling



Primary Outcome Measures :
  1. changes in Patient-reported medication Adherence to mood stabilizers [ Time Frame: changes from baseline, 1 Months and 6 months follow-up ]
    The Medication Adherence Report Scale (MARS-5) will be used for assessing medication adherence to the mood stabilizers


Secondary Outcome Measures :
  1. Plasma level of mood stabilizer [ Time Frame: Changes from baseline, 1 Months and 6 months after the intervention ]
  2. Changes in action planning [ Time Frame: Changes from baseline, 1 Months and 6 months after the intervention ]
    A self-reported questionnaire on five 5-point scale that ranged from 1 (strongly disagree) to 5 (strongly agree)

  3. Changes in coping planning [ Time Frame: Changes from baseline, 1 Months and 6 months after the intervention ]
    A self-reported questionnaire on five 5-point scale that ranged from 1 (strongly disagree) to 5 (strongly agree)

  4. Changes in quality of life [ Time Frame: Changes from baseline, 1 Months and 6 months after the intervention ]
  5. Changes in psychological predictors of medication adherence (intention, perceived behavioral control ,Self-monitoring and Behaviour Automaticity) [ Time Frame: Changes from baseline, 1 Months and 6 months after the intervention ]
  6. Changes in Global Impression for Bipolar Disorder Severity scale (CGI-BP-S) [ Time Frame: Changes from baseline, 1 Months and 6 months after the intervention ]
  7. Changes in Beliefs about Medicines Questionnaire (BMQ) [ Time Frame: Changes from baseline, 1 Months and 6 months after the intervention ]
  8. Changes in Young Mania Rating Scale (YMRS) [ Time Frame: Changes from baseline, 1 Months and 6 months after the intervention ]
  9. Changes in Montgomery Asberg Depression Rating Scale [ Time Frame: Changes from baseline, 1 Months and 6 months after the intervention ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age ≥18 years
  2. meeting DSM-IV criteria for bipolar I or II disorder
  3. concurrently treated with a mood stabilizer
  4. not currently in weekly or biweekly psychotherapy
  5. Persian speaking.

Exclusion Criteria:

  • DSM-IV drug or alcohol misuse disorders (excluding nicotine),
  • pregnancy or planning pregnancy in the next year
  • requiring changing the drug or the dose of a mood stabilizer
  • evidence of severe DSM-IV borderline personality
  • Unable or unwilling to give written informed consent.
  • An organic cerebral cause for bipolar disorder—for example, multiple sclerosis or stroke.
  • intellectual disability

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 ClinicalTrials.gov identifier (NCT number): NCT02241863


Locations
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Iran, Islamic Republic of
22 Bahman Hospital
Qazvin, Iran, Islamic Republic of, 3419759811
Sponsors and Collaborators
Qazvin University Of Medical Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Amir H Pakpour, Head of the Social Determinants of Health Research Center, Qazvin University Of Medical Sciences
ClinicalTrials.gov Identifier: NCT02241863     History of Changes
Other Study ID Numbers: 353
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: January 5, 2016
Last Verified: October 2015
Keywords provided by Amir H Pakpour, Qazvin University Of Medical Sciences:
bipolar disorders
medication adherence
psychological intervention
multifaceted intervention
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders