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

NCT ID: NCT07014241

Last Updated: 2025-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Major Depressive Disorder (MDD)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Telehealth family psychoeducation

Dyads of individuals with MDD who have been prescribed at least one antidepressant medication and their family members or caregivers

Group Type EXPERIMENTAL

Family psychoeducation

Intervention Type OTHER

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 engage actively in treatment decision-making.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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 engage actively in treatment decision-making.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Southern Queensland

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Professor Benjamin Tan BNSc MMed PhD RN

Professor of Nursing

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bakewell Medical Centre

Bakewell, Northern Territory, Australia

Site Status

Palmerston Medical Clinic

Palmerston, Northern Territory, Australia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Australia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Obumneke Obieche

Role: CONTACT

+61406570543

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Obumneke Obieche

Role: primary

+61406570543

Obumneke Obieche

Role: primary

+61406570543

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 41149679 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HREC 2025-5059

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.