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

U

University of Southern Queensland

Status

Not yet enrolling

Conditions

Major Depressive Disorder (MDD)

Treatments

Other: Family psychoeducation

Study type

Interventional

Funder types

Other

Identifiers

NCT07014241
HREC 2025-5059

Details and patient eligibility

About

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.

Enrollment

26 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

26 participants in 1 patient group

Telehealth family psychoeducation
Experimental group
Description:
Dyads of individuals with MDD who have been prescribed at least one antidepressant medication and their family members or caregivers
Treatment:
Other: Family psychoeducation

Trial contacts and locations

2

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Central trial contact

Obumneke Obieche

Data sourced from clinicaltrials.gov

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