Major Depressive Disorder (MDD)SPARKEDNCT07014241
Assessment of Whether Telehealth Family Psychoeducation for Major Depressive Disorder is Doable
A study testing Family psychoeducation in people with Major Depressive Disorder (MDD), run by University of Southern Queensland at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- Family psychoeducation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesAustralia
- Study dates
- Nov 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites
Bakewell Medical Centre
Bakewell, Northern Territory, 0832
Obumneke Obieche, +61406570543, obumneke.obieche@unisq.edu.au
Palmerston Medical Clinic
Palmerston, Northern Territory, 0830
Obumneke Obieche, +61406570543, obumneke.obieche@unisq.edu.au
About this study
Official title: Feasibility Study of Telehealth Family Psychoeducation for Major Depressive Disorder
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?
Read more
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)
- Being tested
- Family psychoeducation
- Keywords
- Family psychoeducation, Major depressive disorder, Telehealth, Feasibility study
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family psychoeducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Telehealth family psychoeducation | Experimental | Dyads of individuals with MDD who have been prescribed at least one antidepressant medication and their family members or caregivers Receives: Other: Family psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three months beginning on the date the feasibility study flyer is displayed.
Retention
The percentage of participants who remain in the study.
Measured: 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.
Measured: 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.
Measured: From enrolment to the end of the six-week follow-up.
Prospective acceptability
Number of eligible participants who consented to study participation
Measured: During the recruitment period, lasting approximately three months.
Concurrent acceptability
Number of family psychoeducational sessions attended and reasons for dropout
Measured: 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.
Measured: At six-week follow-up.
Secondary outcomes (4)
Personal recovery among study participants with MDD
This outcome refers to subjective recovery, which will be assessed using the Recovery Assessment Scale-Domains and Stages (RAS-DS), a 38-item self-rated measure of personal recovery.
The RAS-DS is a 4-point Likert scale that includes four recovery domains: Doing Things I Value, Looking Forward, Mastering My Illness, and Connecting and Belonging. Each item can be rated as "Untrue," "A bit True," "Mostly True," or "Completely True," with corresponding numerical values of 1 to 4. Scores are summed to obtain the total recovery score, with minimum and maximum scores of 38 and 152, respectively. A lower total recovery score suggests a reduced sense of recovery, while a higher score indicates a greater sense of recovery.
The percentage domain score will be calculated to assess differences across domains at a specific time point and to evaluate changes in the domains over the three measurement time points. Item scores within each domain are summed to obtain the total domain score.
Measured: At baseline (T0), immediately post-intervention (T1), and 6-week follow-up (T2)
Depressive symptoms among participants with MDD
The Patient Health Questionnaire-9 scale, a brief instrument comprising nine items, will be used to evaluate the presence and severity of depressive symptoms. Each item on this scale is rated from 0 to 3, where a score of 0 indicates "Not at all," 1 indicates "Several days," 2 indicates "More than half the days," and 3 indicates "Nearly every day." All scores are summed to get a total score that indicates the severity of depression. The minimum and maximum values are 0 and 27, respectively. A total score of 1-4 indicates minimal depression, 5-9 indicates mild depression, 10-14 indicates moderate depression, 15-19 indicates moderately severe depression, and 20-27 indicates severe depression.
Measured: At baseline (T0), immediately post-intervention (T1), and 6-week follow-up (T2).
Antidepressant medication adherence among participants with MDD
In this study, antidepressant medication adherence refers to how much a person's medication-taking behaviours correspond with a prescriber's recommendations. The medication adherence measurement will involve the Medication Adherence Report Scale-5 (MARS-5), a validated, five-item, self-report measure examining intentional and nonintentional nonadherence behaviours.
Each item is rated "Always," "Often," "Sometimes," "Rarely," or "Never," which are scored from 1 to 5, respectively. All scores are added up to get a total score. The minimum and maximum values are 5 and 25, respectively. Lower total scores mean lower adherence, while higher total scores indicate higher adherence.
Measured: 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
Necessity beliefs and concerns regarding antidepressant medication will be assessed in all participants using the Beliefs about Medicines Questionnaire-Specific (BMQ-Specific). The BMQ-Specific is an 11-item measure comprising two subscales assessing beliefs about the need for medication prescribed for treatment (Specific-Necessity, five items) and concerns about the medication's potential adverse effects (Specific-Concerns, 6 items).
Each item is rated as "Strongly Agree," "Agree," "Uncertain," "Disagree," or "Strongly Disagree," and scored from 5 to 1, respectively. Scores on the Specific Necessity scale are summed. Similarly, scores on the Specific Concerns scale are added up. A scale score is determined by dividing the sum of scores on each scale by the respective number of items on the scale. High Specific Necessity scale scores mean strong beliefs about the need for prescribed medication, while high Specific Concerns scale scores mean strong concerns regarding the medications.
Measured: At baseline (T0), immediately post-intervention (T1), and 6-week follow-up (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study startNov 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Queensland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Benjamin Tan BNSc MMed PhD RN, University of Southern Queensland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014241
- Sponsor's protocol ID
- HREC 2025-5059
- Acronym
- SPARKED
- Status last verified
- Jun 2025
- First submitted
- 26 May 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study datasets contain sensitive personal information and are stored securely with restricted access. Access is subject to approval by the relevant ethics committees and data custodians.
Publications
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.
PubMed 41149679
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Telehealth Family Psychoeducation for Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT07014241
- Acronym / sponsor ID
- SPARKED / HREC 2025-5059
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- Family psychoeducation, Major depressive disorder, Telehealth, Feasibility study
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University of Southern QueenslandUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telehealth family psychoeducation | Experimental | Other: Family psychoeducationDyads of individuals with MDD who have been prescribed at least one antidepressant medication and their family members or caregivers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family psychoeducationThe 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. | Other | Telehealth family psychoeducation |
Primary outcome
Recruitment rate
Time frame: Three months beginning on the date the feasibility study flyer is displayed.
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.
Retention
Time frame: Across the entire trial period, from enrolment to six-week follow-up.
The percentage of participants who remain in the study.
Outcome measure return rate
Time frame: From enrolment to the end of six-week follow-up.
The percentage of participants who return filled-out self-report measures.
Outcome measure completion rate
Time frame: From enrolment to the end of the six-week follow-up.
The percentage of participants who successfully complete a specific outcome measurement.
Prospective acceptability
Time frame: During the recruitment period, lasting approximately three months.
Number of eligible participants who consented to study participation
Concurrent acceptability
Time frame: From the first biweekly session to the end of the six-week follow-up
Number of family psychoeducational sessions attended and reasons for dropout
Retrospective acceptability.
Time frame: At six-week follow-up.
Feedback on telehealth family psychoeducation for MDD, including what worked well, barriers encountered, and suggestions for improvement.
4 secondary outcomes
Personal recovery among study participants with MDD
Time frame: At baseline (T0), immediately post-intervention (T1), and 6-week follow-up (T2)
Depressive symptoms among participants with MDD
Time frame: At baseline (T0), immediately post-intervention (T1), and 6-week follow-up (T2).
Antidepressant medication adherence among participants with MDD
Time frame: 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
Time frame: At baseline (T0), immediately post-intervention (T1), and 6-week follow-up (T2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Derived from this study: PubMed 41149679Obieche 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.
- Individual participant dataSharing planned: No. The study datasets contain sensitive personal information and are stored securely with restricted access. Access is subject to approval by the relevant ethics committees and data custodians.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family psychoeducation in people with Major Depressive Disorder (MDD), run by University of Southern Queensland at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Obumneke Obieche (+61406570543, obumneke.obieche@unisq.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Three months beginning on the date the feasibility study flyer is displayed.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07014241, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.