Feasibility Study of Telehealth Family Psychoeducation for Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 26
- 试验地点
- 4
- 主要终点
- Recruitment rate
研究概览
简要总结
The goal of this single-arm interventional study is to assess the feasibility and acceptability of co-designed telehealth family psychoeducation (FPE) among individuals with major depressive disorder (MDD) and families. The study will also assess the intervention's preliminary impact on personal recovery, antidepressant medication adherence, depression severity, and medication necessity beliefs and concerns. The main questions it aims to answer are:
- What are patients', families', and mental health professionals' views about telehealth FPE for MDD?
- What are the feasibility and acceptability of telehealth FPE for MDD among individuals with MDD and their families?
- What is the preliminary impact of telehealth FPE for MDD on personal recovery, antidepressant medication adherence, depression severity, and medication necessity beliefs and concerns?
Study participants will include individuals with MDD who have prescriptions for antidepressant medications and their family members. Participants will receive three biweekly FPE sessions and a six-week follow-up session via telehealth using a single-family format. The study intervention, telehealth family psychoeducation for MDD, will cover structured modules to enhance participants' understanding of MDD and its treatment, coping strategies, and self-efficacy skills. It will also focus on recognising early signs of relapse and empowering participants to engage in treatment decision-making actively. Hence, the study intervention is termed the Supportive Program for Advancing Recovery, Knowledge, and Empowerment in Depression (SPARKED).
At baseline, post-intervention, and follow-up, participants with MDD will complete self-reported measures for personal recovery, antidepressant medication adherence, depression severity, and medication necessity beliefs and concerns. In contrast, their family members or caregivers will complete only an outcome measure for medication necessity beliefs and concerns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •An individual (aged 18 years or older) with a diagnosis of MDD who has a prescription for at least one antidepressant medication for treating MDD
- •The individual has a family member, family caregiver, or significant other (aged 18 years or older) who plays a role in supporting the individual at home
- •Both the individual with MDD and their support person have basic English language skills, enabling them to engage in family psychoeducational sessions and respond to self-report outcome measures.
- •Both the individual with MDD and their support person voluntarily consent to participate in the study.
排除标准
- •An individual (aged 18 years or older) who does not have a prescription for at least one antidepressant medication for treating MDD
- •An individual (aged 18 years or older) with MDD whose family member, caregiver, or significant other could not participate in the study
- •An individual (aged 18 years or older) with MDD who has high or imminent suicide risk
- •An individual with MDD who has other serious mental or physical illnesses, cognitive impairment, or hearing impairment without a hearing aid
- •A family member, caregiver, or significant other to an individual with MDD who does not consent to participate in the study
结局指标
主要结局
Recruitment rate
时间窗: Three months beginning on the date the feasibility study flyer is displayed.
The total number of eligible participant dyads (an individual with MDD and a supportive family member) enrolled on the feasibility study within the recruitment period.
Retention
时间窗: Across the entire trial period, from enrolment to six-week follow-up.
The percentage of participants who remain in the study.
Outcome measure return rate
时间窗: From enrolment to the end of six-week follow-up.
The percentage of participants who return filled-out self-report measures.
Outcome measure completion rate
时间窗: From enrolment to the end of the six-week follow-up.
The percentage of participants who successfully complete a specific outcome measurement.
Prospective acceptability
时间窗: During the recruitment period, lasting approximately three months.
Number of eligible participants who consented to study participation
Concurrent acceptability
时间窗: From the first biweekly session to the end of the six-week follow-up
Number of family psychoeducational sessions attended and reasons for dropout
Retrospective acceptability.
时间窗: At six-week follow-up.
Feedback on telehealth family psychoeducation for MDD, including what worked well, barriers encountered, and suggestions for improvement.
次要结局
- Personal recovery among study participants with MDD(At baseline (T0), immediately post-intervention (T1), and 6-week follow-up (T2))
- Depressive symptoms among participants with MDD(At baseline (T0), immediately post-intervention (T1), and 6-week follow-up (T2).)
- Antidepressant medication adherence among participants with MDD(At baseline (T0), immediately post-intervention (T1), and 6-week follow-up (T2))
- Medication necessity beliefs and concerns among participants with MDD and their family members(At baseline (T0), immediately post-intervention (T1), and 6-week follow-up (T2))
研究者
Professor Benjamin Tan BNSc MMed PhD RN
Professor of Nursing
University of Southern Queensland