Patients With Bipolar Disorders Clinical Trial
| NCT number | NCT02241863 |
| Other study ID # | 353 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | September 2014 |
| Verified date | January 2023 |
| Source | Qazvin University Of Medical Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 270 |
| Est. completion date | |
| Est. primary completion date | September 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Iran, Islamic Republic of | Boostan | Ahvaz | |
| Iran, Islamic Republic of | Ebn'e Sina | Mashhad | |
| Iran, Islamic Republic of | 22 Bahman Hospital | Qazvin | |
| Iran, Islamic Republic of | Psychiatry Center | Semnan | |
| Iran, Islamic Republic of | Shahid Mahallati | Tabriz | |
| Iran, Islamic Republic of | Iran Psychiatry | Tehran | |
| Iran, Islamic Republic of | Maymanat | Tehran | |
| Iran, Islamic Republic of | Roozbeh | Tehran | |
| Iran, Islamic Republic of | Baharan | Zahedan | |
| Iran, Islamic Republic of | Dr. Beheshti | Zanjan |
| Lead Sponsor | Collaborator |
|---|---|
| Qazvin University Of Medical Sciences |
Iran, Islamic Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | changes in Patient-reported medication Adherence to mood stabilizers | The Medication Adherence Report Scale (MARS-5) will be used for assessing medication adherence to the mood stabilizers | changes from baseline, 1 Months and 6 months follow-up | |
| Secondary | Plasma level of mood stabilizer | Changes from baseline, 1 Months and 6 months after the intervention | ||
| Secondary | Changes in action planning | A self-reported questionnaire on five 5-point scale that ranged from 1 (strongly disagree) to 5 (strongly agree) | Changes from baseline, 1 Months and 6 months after the intervention | |
| Secondary | Changes in coping planning | A self-reported questionnaire on five 5-point scale that ranged from 1 (strongly disagree) to 5 (strongly agree) | Changes from baseline, 1 Months and 6 months after the intervention | |
| Secondary | Changes in quality of life | Changes from baseline, 1 Months and 6 months after the intervention | ||
| Secondary | 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 | ||
| Secondary | Changes in Global Impression for Bipolar Disorder Severity scale (CGI-BP-S) | Changes from baseline, 1 Months and 6 months after the intervention | ||
| Secondary | Changes in Beliefs about Medicines Questionnaire (BMQ) | Changes from baseline, 1 Months and 6 months after the intervention | ||
| Secondary | Changes in Young Mania Rating Scale (YMRS) | Changes from baseline, 1 Months and 6 months after the intervention | ||
| Secondary | Changes in Montgomery Asberg Depression Rating Scale | Changes from baseline, 1 Months and 6 months after the intervention |