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Completed

NCT Number: NCT02241863

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

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.

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Key information

Conditions

Patients With Bipolar Disorders Behavior Bipolar Disorder Bipolar and Related Disorders Health Behavior Medication Adherence Mental Disorders Mood Disorders Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boostan, Ahvāz, Iran

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age ≥18 years
  • meeting DSM-IV criteria for bipolar I or II disorder
  • concurrently treated with a mood stabilizer
  • not currently in weekly or biweekly psychotherapy
  • 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

Treatment and study plan

Multifaceted intervention

Behavioral

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.

Routine counseling

Behavioral

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Qazvin University Of Medical Sciences

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
First posted
Sep 16, 2014
Registry last updated
Jan 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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