Clinical trial NCT07014241: Assessment of Whether Telehealth Family Psychoeducation for Major Depressive Disorder is Doable
Official title: Feasibility Study of Telehealth Family Psychoeducation for Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Major Depressive Disorder (MDD)
Keywords: Family psychoeducation
Major depressive disorder
Telehealth
Feasibility study
Lead sponsor: University of Southern Queensland
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Recruitment rate
timeFrame: Three months beginning on the date the feasibility study flyer is displayed.
measure: Retention
timeFrame: Across the entire trial period, from enrolment to six-week follow-up.
measure: Outcome measure return rate
timeFrame: From enrolment to the end of six-week follow-up.
measure: Outcome measure completion rate
timeFrame: From enrolment to the end of the six-week follow-up.
measure: Prospective acceptability
timeFrame: During the recruitment period, lasting approximately three months.
measure: Concurrent acceptability
timeFrame: From the first biweekly session to the end of the six-week follow-up
measure: Retrospective acceptability.
timeFrame: At six-week follow-up.
Secondary outcomes:
measure: Personal recovery among study participants with MDD
timeFrame: At baseline (T0), immediately post-intervention (T1), and 6-week follow-up (T2)
measure: Depressive symptoms among participants with MDD
timeFrame: At baseline (T0), immediately post-intervention (T1), and 6-week follow-up (T2).
measure: Antidepressant medication adherence among participants with MDD
timeFrame: At baseline (T0), immediately post-intervention (T1), and 6-week follow-up (T2)
measure: Medication necessity beliefs and concerns among participants with MDD and their family members
timeFrame: At baseline (T0), immediately post-intervention (T1), and 6-week follow-up (T2)
Other outcomes:
Locations:
city: Bakewell
country: Australia
facility: Bakewell Medical Centre
state: Northern Territory
city: Palmerston
country: Australia
facility: Palmerston Medical Clinic
state: Northern Territory
Study officials:
References: