Patients With Bipolar DisordersNCT02241863
The Effect of a Theory Based Educational Intervention on Medication Adherence to and Removes of Related Barriers in Patients With Bipolar Disorder
A study testing Multifaceted intervention and Routine counseling in people with Patients With Bipolar Disorders, run by Qazvin University Of Medical Sciences at 10 sites in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Bipolar Disorders
- What is being tested?
- Multifaceted intervention and Routine counseling
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 10 sitesIran
- Study dates
- Sep 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
10 sites in 1 country.
10 sites in 1 country
Iran10 sites
Boostan
Ahvāz
Ebn'e Sina
Mashhad
22 Bahman Hospital
Qazvin, 3419759811
Psychiatry Center
Semnan
Shahid Mahallati
Tabriz
Iran Psychiatry
Tehran
Maymanat
Tehran
Roozbeh
Tehran
Baharan
Zahedan
Dr. Beheshti
Zanjan
About this study
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.
- Conditions
- Patients With Bipolar Disorders
- Being tested
- Multifaceted intervention, Routine counseling
- Keywords
- bipolar disorders, medication adherence, psychological intervention, multifaceted intervention
- Medical subject headings
- Bipolar Disorder, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifaceted interventionBehavioural
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 counselingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Multifaceted intervention | Experimental | Patients, their caregivers and family members will received the educational and motivational interventions Receives: Behavioral: Multifaceted intervention |
| Active Comparator | Active comparator | Usual Care The usual care group received routine counseling performed by the psychiatrist and nurses. Receives: Behavioral: Routine counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: changes from baseline, 1 Months and 6 months follow-up
Secondary outcomes (9)
Plasma level of mood stabilizer
Measured: Changes from baseline, 1 Months and 6 months after the intervention
Changes in action planning
A self-reported questionnaire on five 5-point scale that ranged from 1 (strongly disagree) to 5 (strongly agree)
Measured: Changes from baseline, 1 Months and 6 months after the intervention
Changes in coping planning
A self-reported questionnaire on five 5-point scale that ranged from 1 (strongly disagree) to 5 (strongly agree)
Measured: Changes from baseline, 1 Months and 6 months after the intervention
Changes in quality of life
Measured: 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)
Measured: Changes from baseline, 1 Months and 6 months after the intervention
Changes in Global Impression for Bipolar Disorder Severity scale (CGI-BP-S)
Measured: Changes from baseline, 1 Months and 6 months after the intervention
Changes in Beliefs about Medicines Questionnaire (BMQ)
Measured: Changes from baseline, 1 Months and 6 months after the intervention
Changes in Young Mania Rating Scale (YMRS)
Measured: Changes from baseline, 1 Months and 6 months after the intervention
Changes in Montgomery Asberg Depression Rating Scale
Measured: Changes from baseline, 1 Months and 6 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients With Bipolar DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qazvin University Of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir H Pakpour, Qazvin University Of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02241863
- Sponsor's protocol ID
- 353
- Status last verified
- Jan 2023
- First submitted
- 4 Sep 2014
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pakpour AH, Modabbernia A, Lin CY, Saffari M, Ahmadzad Asl M, Webb TL. Promoting medication adherence among patients with bipolar disorder: a multicenter randomized controlled trial of a multifaceted intervention. Psychol Med. 2017 Oct;47(14):2528-2539. doi: 10.1017/S003329171700109X. Epub 2017 Apr 27.
PubMed 28446253
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Theory Based Educational Intervention on Medication Adherence to and Removes of Related Barriers in Patients With Bipolar Disorder
- ClinicalTrials.gov ID
- NCT02241863
- Acronym / sponsor ID
- 353
- Conditions
- Patients With Bipolar Disorders
- Keywords
- bipolar disorders, medication adherence, psychological intervention, multifaceted intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Qazvin University Of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (actual)
- First posted
- 16 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multifaceted intervention | Experimental | Behavioral: Multifaceted interventionPatients, their caregivers and family members will received the educational and motivational interventions |
| Active Comparator | Active comparator | Behavioral: Routine counselingUsual Care The usual care group received routine counseling performed by the psychiatrist and nurses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multifaceted interventionSupportive 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. | Behavioural | Multifaceted intervention |
| Routine counseling | Behavioural | Active Comparator |
Primary outcome
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
9 secondary outcomes
Plasma level of mood stabilizer
Time frame: Changes from baseline, 1 Months and 6 months after the intervention
Changes in action planning
Time frame: Changes from baseline, 1 Months and 6 months after the intervention
Changes in coping planning
Time frame: Changes from baseline, 1 Months and 6 months after the intervention
Changes in quality of life
Time frame: 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)
Time frame: Changes from baseline, 1 Months and 6 months after the intervention
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
Changes in Beliefs about Medicines Questionnaire (BMQ)
Time frame: Changes from baseline, 1 Months and 6 months after the intervention
Changes in Young Mania Rating Scale (YMRS)
Time frame: Changes from baseline, 1 Months and 6 months after the intervention
Changes in Montgomery Asberg Depression Rating Scale
Time frame: Changes from baseline, 1 Months and 6 months after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Derived from this study: PubMed 28446253Pakpour AH, Modabbernia A, Lin CY, Saffari M, Ahmadzad Asl M, Webb TL. Promoting medication adherence among patients with bipolar disorder: a multicenter randomized controlled trial of a multifaceted intervention. Psychol Med. 2017 Oct;47(14):2528-2539. doi: 10.1017/S003329171700109X. Epub 2017 Apr 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multifaceted intervention and Routine counseling in people with Patients With Bipolar Disorders, run by Qazvin University Of Medical Sciences at 10 sites in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in Patient-reported medication Adherence to mood stabilizers (time frame: changes from baseline, 1 Months and 6 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02241863, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.