Assessment of Whether Telehealth Family Psychoeducation for Major Depressive Disorder is Doable

Официальное название

Feasibility Study of Telehealth Family Psychoeducation for Major Depressive Disorder

Обзор

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.

Вмешательства

• Другое Family psychoeducation
  The study intervention, tagged SPARKED (Supportive Program for Advancing Recovery, Knowledge, and Empowerment in Depression), is a co-designed family-based psychoeducational intervention for individuals with MDD and their family members or caregivers. The intervention 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 eng

Первичные конечные точки

• Recruitment rate [Срок оценки: Three months beginning on the date the feasibility study flyer is displayed.]
• Retention [Срок оценки: Across the entire trial period, from enrolment to six-week follow-up.]
• Outcome measure return rate [Срок оценки: From enrolment to the end of six-week follow-up.]
• Outcome measure completion rate [Срок оценки: From enrolment to the end of the six-week follow-up.]
• Prospective acceptability [Срок оценки: During the recruitment period, lasting approximately three months.]
• Concurrent acceptability [Срок оценки: From the first biweekly session to the end of the six-week follow-up]
• Retrospective acceptability. [Срок оценки: At six-week follow-up.]

Вторичные конечные точки (4)

• Personal recovery among study participants with MDD [Срок оценки: At baseline (T0), immediately post-intervention (T1), and 6-week follow-up (T2)]
• Depressive symptoms among participants with MDD [Срок оценки: At baseline (T0), immediately post-intervention (T1), and 6-week follow-up (T2).]
• Antidepressant medication adherence among participants with MDD [Срок оценки: 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 [Срок оценки: At baseline (T0), immediately post-intervention (T1), and 6-week follow-up (T2)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Австралия · 2 центра

• Bakewell Medical Centre — Bakewell
• Palmerston Medical Clinic — Palmerston

Публикации

• Obieche O, Tan JB, Sharma S, Bressington D, Wang T. Telehealth Family Psychoeducation for Major Depressive Disorder: A Protocol for Intervention Co-Design and Feasibility Study. Nurs Rep. 2025 Oct 11;15(10):364. doi: 10.3390/nursrep15100364. PMID 41149679

Идентификаторы

NCT: NCT07014241 · HREC 2025-5059

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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