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

NCT07014241 | Not Yet Recruiting

• 1 other identifier: HREC 2025-5059
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

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.

Conditions

Major Depressive Disorder (MDD)

Keywords

Family psychoeducation; Major depressive disorder; Telehealth; Feasibility study

Outcome Measures

Primary Outcomes (7)

• Recruitment rate

  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.

  Three months beginning on the date the feasibility study flyer is displayed.

• Retention

  The percentage of participants who remain in the study.

  Across the entire trial period, from enrolment to six-week follow-up.

• Outcome measure return rate

  The percentage of participants who return filled-out self-report measures.

  From enrolment to the end of six-week follow-up.

• Outcome measure completion rate

  The percentage of participants who successfully complete a specific outcome measurement.

  From enrolment to the end of the six-week follow-up.

• Prospective acceptability

  Number of eligible participants who consented to study participation

  During the recruitment period, lasting approximately three months.

• Concurrent acceptability

  Number of family psychoeducational sessions attended and reasons for dropout

  From the first biweekly session to the end of the six-week follow-up

• Retrospective acceptability.

  Feedback on telehealth family psychoeducation for MDD, including what worked well, barriers encountered, and suggestions for improvement.

  At six-week follow-up.

Secondary Outcomes (4)

• 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)

Study Arms (1)

Telehealth family psychoeducation

EXPERIMENTAL

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

Other: Family psychoeducation

Interventions

Family psychoeducation 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.

Telehealth family psychoeducation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern Queensland: lead

Study Sites (2)

Bakewell Medical Centre

Bakewell, Northern Territory, 0832, Australia

Location

Palmerston Medical Clinic

Palmerston, Northern Territory, 0830, Australia

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Obumneke Obieche

CONTACT

+61406570543; obumneke.obieche@unisq.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nursing

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 10, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)