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

Qazvin University Of Medical Sciences

Status: Completed

Conditions: Patients With Bipolar Disorders

Treatments: Behavioral: Routine counseling; Behavioral: Multifaceted intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02241863

353

Details and patient eligibility

About

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.

Enrollment: 270 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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270 participants in 2 patient groups

Multifaceted intervention

Experimental group

Description:

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

Treatment:

Behavioral: Multifaceted intervention

Active Comparator

Active Comparator group

Description:

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

Treatment:

Behavioral: Routine counseling