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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Patients With Bipolar Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Multifaceted intervention

Patients, their caregivers and family members will received the educational and motivational interventions

Group Type EXPERIMENTAL

Multifaceted intervention

Intervention Type 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.

Active Comparator

Usual Care The usual care group received routine counseling performed by the psychiatrist and nurses.

Group Type ACTIVE_COMPARATOR

Routine counseling

Intervention Type BEHAVIORAL

Interventions

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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.

Intervention Type BEHAVIORAL

Routine counseling

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No