Management of my Bipolarity Intervention in Bipolar Disorder Patients

NCT04643210 | Unknown

• 2 other identifiers: 5.34.01.7.6Ε/0490/2018EEBK/EΠ/2018/27
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The Management of my Bipolarity study aims to develop an educational intervention (MoB EI) on the combined use of technology and face to face education on the empowerment of ill health self-management skills in adults with bipolar disorder. The MoB EI will be developed according to qualitative data on patients' educational needs and relevant literature. The effectiveness of acquired knowledge and self-management skills will be assessed according to the degree of a) cognitive functioning, b) impulse control, c) adherence to pharmacotherapy, d) relapse prevention, d) improvement of quality of life of participants.

Conditions

Bipolar Disorder; Affective Psychosis, Bipolar; Manic-Depressive Psychosis; Depression, Bipolar

Keywords

Education; Empowerment; Bipolar Disorder; Self-management

Outcome Measures

Primary Outcomes (13)

• Bipolar disease patients educational needs

  Qualitative measures: 1. Knowledge/ mental health literacy on present medical condition (measurement tool \[MT\]/ Open-ended question: Please tell us, what do you know about your mental health condition/ BD?) 2. Knowledge gap regarding BD (MT/ Open ended question: Please describe what you would like to know about bipolar disorders). 3\. Topics to be covered (MT/ Open ended question: Please describe in what way/topics you would like to be educated on bipolar disorders/to increase your knowledge about bipolar disorders? 4. Educational and feasibility expectations (MT/ Open-ended questions: a. Please describe your expectations from an educational program regarding the impact on your everyday living b. How you would like this program to be implemented one on one or in a group? C. How long would you like the program to last? 5. e-Health literacy (MT/ Open ended question: What is your level of engagement with the Internet?)

  6 months

• Degree of self-perceived quality of life as measured by the total score in the scale "World Health Organization Quality of Life Assessment".

  The scale "World Health Organization Quality of Life Assessment" is a 1-5 Likert type scale including 26 items. The minimum score in the scale is 26 and the maximun is 130. Higher scores indicate a better outcome.

  18 months

• Level of knowledge regarding BD, as measured by the total score in the scale "Bipolar Disorder Knowledge Scale".

  The "Bipolar Disorder Knowledge Scale" is a 25-item true-false scale. The scale assesses knowledge of BD with items targeting diagnosis, etiology, disease course, symptoms, treatment, and life impact. The ration of "true" to "false" responses is assessed. Higher percentage values indicate a better outcome.

  18 months

• Degree of ability to control impulses, as measured by the total score in the scale "YOUNG MANIA RATING SCALE " (YMRS) .

  The "YMRS" is a 0-4 likert scale, including 11 items. The total score of the scale ranges from 0 to 44. The lower the total score the better the outcome.

  18 months

• Degree of adherence to pharmacotherapy, as measured by the total score in the scale "Drug Attitude Inventory" (DAI).

  The "DAI" is a 30 item "true-false" scale.The ration of "true" to "false" responses is assessed. Higher percentage values indicate a better outcome.

  18 months

• Degree of dysfunctional attitudes towards substance use as measured by the total score in the scale "Drug Use Disorders Identification Test" (DUDIT).

  The scale DUDIT is a 1-5 Likert, 11-item scale (scale total score range: 1-55) . The lower the total score the better the outcome. Lower scores indicate a better outcome.

  18 months

• Degree of dysfunctional attitudes towards alcohol as measured by the total score in the scale "Alcohol Use Disorders Identification Test" (AUDIT).

  The AUDIT scale is a 0-4 Likert, 10-item scale (scale total score range: 0-40) . Lower scores indicate a better outcome.

  18 months

• Frequency of relapses, as measured by the number of hospitalizations after the completion of the face to face intervention.

  The number of hospitalizations will be measured as the sum of the individual hospitalizations in a high security psychaitric hospital. The lower the number of the frequency the better the outcome.

  Two years following the end of the face tot face educational intervention.

• Reduced duration of relapses, as measured by the duration of inpatient hospitalizations in days after the completion of the face to face intervention.

  The duration of inpatient hospitalizations will be measured as the sum of the days of hospitalization in high security psychaitric hospitals. The lower the duration in days of the hospitalization the better the outcome.

  Two years following the end of the face to face educational intervention.

• Degree of feasibility of the digital platform, as measured by users' qualitative feedback on the following open-ended question: "Please tell us, what was your experience with the MoB DP use?

  The more positive the described experience the better the outcome.

  6 months

• Degree of feasibility of the digital platform, as measured by the users' qualitative feedback on the impact of the MoB DP on their life based on the following open-ended question: "Please tell us, what was the impact of the MoB DP use on your life?"

  The more positive the described impact of the MoB DP on users' life the better the outcome.

  6 months

• Degree of feasibility of the digital platform, measured by users' feedback on the impact of the platform on their self-management skills based on the question "What was the impact of the platform on your ill health self-management skills?"

  The more positive the described impact of the digital platform on users' ill health self-management skills the better the outcome.

  6 months

• Degree of feasibility of the digital platform, as measured by users' self-reported degree of satisfaction on MoB DP by the total score on the scale "Users' Satisfaction Scale" (USS).

  The USS is 1-3 Likert scale (low;moderate/accepted; high), which includes 6 items, assessing users' perceptions about overall experienced satisfaction (item1); utility according to their present medical condition (item 2); feasibility on daily usage (item 3); technical difficulties experienced (item 4); improvement of BD self-management skills (item 5); improvement of BD knowledge (item 6). The total score of the USS ranges between 6- 18. The higher the total score the better the outcome.

  6 months

Secondary Outcomes (4)

• Description of the topics of the MoB educational intervention through a qualitative measure.

  6 months

• Description of the mode of the MoB educational intervention through a qualitative measure.

  6 months

• Description of the different modes of the MoB educational intervention through a qualitative measure.

  6 months

• Description of the MoB DP technology-based intervention through a qualitative measure.

  6 months

Study Arms (2)

F2F MoB EI and access to MoB Digital Platform (MoB DP) group

EXPERIMENTAL

The design of the face-to-face Management of my Bipolarity educational intervention (F2F MoB EI) will rely on the Colom \& Vieta model, Cognitive- Behavioural techniques and the results of the relevant literature review and data acquired in the qualitative research of bipolar disease patients' educational needs. A textbook will be devised explaining in detail the step-by-step process and the techniques of the experimental educational method of the MoB F2F EI. This group will also receive the technology-based intervetion, which regards access to the MoB DP. This is an ecosystem where the participants will be educated and empowered making use of the internet of things (IOT) via a computer, tablet or mobile.

Behavioral: F2F MoB EI; Other: MoB DP

The MoB DP group

ACTIVE COMPARATOR

This group will receive the technology-based intervention, which regards access to the MoB DP. The structure of the MoB DP has been partially based on the preferences and needs of the participants (as described in the qualitative part of the study) and its goal is to create an ecosystem where users will be educated and empowered making use of the internet of things (IOT) via a computer, tablet or mobile. The Digital platform will be in the form of a dynamic website with user generated content as well as static information.

Other: MoB DP

Interventions

F2F MoB EI BEHAVIORAL

The MoB F2F EI will comprise a total of 12 educational F2F sessions. Each session will have a duration of 1.5 hours and the maximum number of participants in the groups will be 12 patients. The intervention group will receive the MoB F2F EI on group or personal form according to the participant's choice. The implementation methodology of the MoB F2F EI will include videos and power point presentations, as well as interactive learning methods such as role-playing, empowerment exercises, live discussions.

F2F MoB EI and access to MoB Digital Platform (MoB DP) group

MoB DP OTHER

This is a technology-based intervention, which regards access to a dfigital platform, the MoB DP. The structure of the Digital platform has been partially based on the preferences and needs of the participants (as described in the qualitative part of the study) and its goal is to create an ecosystem where users will be educated and empowered making use of the internet of things (IOT) via a computer, tablet or mobile. The Digital platform will be in the form of a dynamic website with user generated content as well as static information.

F2F MoB EI and access to MoB Digital Platform (MoB DP) group; The MoB DP group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis based on DSM-5 for BD type I and II.
• Age between 18 and 65.
• Signed informed consent.
• Stabilized mood status at the beginning of the MoB F2F intervention based on clinical assessment, conducted by the primary investigator (AH).
• Experience of the illness of at least one year based on reported medical record.
• Adequate awareness of the illness, based on the following guide: (a) are you aware of the reason(s) you are using mental health services/ under medication? and (b) are you aware of the aim of the educational intervention in which you may participate?

You may not qualify if:

• Intellectual disability (IQ\<70), based on the Wechsler Adult Intelligence Scale (WAIS).
• Brain damage (e.g, following a stroke), based on diagnostic tests.
• Acute phase of the illness which requires hospitalization.
• Acute phase of the illness, based on clinical assessment, as well as the Young Mania Rating Scale (YMRS) and/or Beck's Depression Inventory (BDI) tools.
• Substance use problems at the beginning of this stage according to the Alcohol Use Disorders Identification Test (AUDIT) and Drug Use Disorders Identification Test (DUDIT) tools.

Sponsors & Collaborators

• Cyprus University of Technology: lead

Study Sites (1)

Cyprus University of Technology

Limassol, 3041, Cyprus

Location

Related Publications (2)

• 21. Hatzioannou A, Papastavrou E, Chatzittofis A, Karanikola M. Exploration of the effectiveness of structured education in empowering people with Bipolar Disorder. Nursing Care & Research 2020;55:246-274.

  BACKGROUND

• Hatzioannou A, Chatzittofis A, Koutroubas VS, Papastavrou E, Karanikola M. Combined Use of Web-Based and In-Person Education on Ill Health Self-management Skills in Adults With Bipolar Disorder: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2021 Sep 8;10(9):e25168. doi: 10.2196/25168.

  PMID: 34494969 DERIVED

MeSH Terms

Conditions

Bipolar Disorder; Empowerment

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Social Behavior; Behavior

Study Officials

• Maria NK Karanikola

  Cyprus University of Technology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Accosiate Professor

Model Details: The study is a combination of a qualitative and a quantitative, interventional (quasi experimental) design. A focus group and content analysis will be implemented for the qualitative assessment of the educational needs of adults with a bipolar disorder. The educational intervention (MoB EI) will be developed according to the qualitative data on patients' educational needs and relevant literature, aiming to include combination of face to face (F2F) and technology-based interventions via design of a Digital platform. The effectiveness of the MoB EI regarding the acquired self-management skill will be assessed via structured instruments in the quantitative part of the study using descriptive and inferential statistics (SPSS version 24.0).

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: November 25, 2020
• Study Start: July 30, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: November 25, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After the end of the study and for the next 5 years
• Access Criteria: These will be decided upon the end of the study

Locations

CY (1)