NCT07014241Not yet recruiting
Assessment of Whether Telehealth Family Psychoeducation for Major Depressive Disorder is Doable
Feasibility Study of Telehealth Family Psychoeducation for Major Depressive Disorder
Source: ClinicalTrials.gov · Last updated 10 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 26 (estimated)
- First submitted
- 26 May 2025
- Start date
- 1 Nov 2025
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- University of Southern Queensland
- Diseases
- Depression
- NCT number
- NCT07014241
What you commit to
- Study type: Interventional
- Planned participants: 26
- From 1 Nov 2025 to the primary completion date, 30 Jun 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- An individual with MDD who has other serious mental or physical illnesses, cognitive impairment, or hearing impairment without a hearing aid
Age
- 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
Other
- A family member, caregiver, or significant other to an individual with MDD who does not consent to participate in the study
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bakewell Medical Centre Coordinator of this site? Confirm its status | Bakewell | Australia | Unknown status |
| Palmerston Medical Clinic Coordinator of this site? Confirm its status | Palmerston | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.