Patients With Bipolar Disorders
Conditions
Keywords
bipolar disorders, medication adherence, psychological intervention, multifaceted intervention
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.
Interventions
BEHAVIORALMultifaceted 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.
BEHAVIORALRoutine counseling
Sponsors
Qazvin University Of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes in Patient-reported medication Adherence to mood stabilizers | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in action planning | 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) |
| Changes in coping planning | 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) |
| Changes in quality of life | Changes from baseline, 1 Months and 6 months after the intervention | — |
| Changes in psychological predictors of medication adherence (intention, perceived behavioral control ,Self-monitoring and Behaviour Automaticity) | Changes from baseline, 1 Months and 6 months after the intervention | — |
| Plasma level of mood stabilizer | Changes from baseline, 1 Months and 6 months after the intervention | — |
| Changes in Beliefs about Medicines Questionnaire (BMQ) | Changes from baseline, 1 Months and 6 months after the intervention | — |
| Changes in Young Mania Rating Scale (YMRS) | Changes from baseline, 1 Months and 6 months after the intervention | — |
| Changes in Montgomery Asberg Depression Rating Scale | Changes from baseline, 1 Months and 6 months after the intervention | — |
| Changes in Global Impression for Bipolar Disorder Severity scale (CGI-BP-S) | Changes from baseline, 1 Months and 6 months after the intervention | — |
Countries
Iran
Outcome results
None listed