Depression - Major Depressive DisorderNCT07919288
Expressive Arts Therapy in Major Depression: An RCT
A study testing Expressive Art Therapy in people with Depression - Major Depressive Disorder, run by Ningbo University.
Trial summary
The goal of this clinical trial is to learn whether expressive arts therapy works to treat major depressive disorder in adults. It will also learn about the safety and feasibility of expressive arts therapy. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Depression - Major Depressive Disorder
- What is being tested?
- Expressive Art Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2026to 1 May 2029
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 1. Male or female, aged between 16 and 60 years. 2. Clinically diagnosed with Major Depressive Disorder (MDD). 3. Score of ≥ 9 on the Patient Health Questionnaire-9 (PHQ-9) at baseline screening.
- 4. Currently receiving or taking antidepressant medication. 5. May have comorbid anxiety symptoms, but must have no history of alcohol or substance dependence.
- 6. Willing to participate in the study and able to provide written informed consent (for participants under 18, parental/guardian consent is required)
Who cannot join
- Presence of severe psychiatric disorders other than MDD, or the duration of the current depressive episode is > 2 years (chronic depression).
- Planning to receive or currently receiving other formal psychological counseling or psychotherapy outside of this study during the research period.
- Score of < 9 on the PHQ-9 at baseline assessment.
- Presence of substance dependence (e.g., alcohol, drugs).
- Unwilling or unable to provide informed consent, or unable to complete the study assessments.
About this study
Official title: A Randomized Controlled Trial of the Effectiveness of Expressive Arts Therapy in the Treatment of Major Depressive Disorder
The goal of this clinical trial is to learn whether expressive arts therapy works to treat major depressive disorder in adults. It will also learn about the safety and feasibility of expressive arts therapy. The main questions it aims to answer are:
- Can expressive arts therapy reduce depressive symptoms in participants with major depressive disorder?
- Can expressive arts therapy reduce alexithymia in participants with major depressive disorder?
- Can expressive arts therapy increase participants' positive psychological capital?
Read more
Researchers will compare expressive arts therapy with a control condition (such as usual care or a waitlist control) to see whether expressive arts therapy works to treat major depressive disorder.
Participants will:
- Receive expressive arts therapy sessions two or three times per week for 4 weeks, or receive the control condition
- Visit the clinic at scheduled intervals for checkups and assessments
- Complete questionnaires about depressive symptoms, alexithymia, and positive psychological capital
- Keep a diary of their mood and therapy-related experiences
- Conditions
- Depression - Major Depressive Disorder
- Being tested
- Expressive Art Therapy, Usual Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expressive Art TherapyBehavioural
Participants in this group will receive structured expressive arts therapy sessions two or three times per week for 2 to 3 weeks. The sessions will be delivered by trained therapists, integrating various art modalities to help participants express emotions and process depressive experiences. Participants will complete questionnaires about depressive symptoms, alexithymia, and positive psychological capital at scheduled intervals, and keep a diary of their mood and therapy-related experiences.
Usual CareBehavioural
Participants in the control group will receive their usual care for major depressive disorder, which may include standard pharmacotherapy and/or routine outpatient counseling. They will not receive expressive arts therapy during the study period. Participants will complete questionnaires about depressive symptoms, alexithymia, and positive psychological capital at the same scheduled intervals as the intervention group, and keep a diary of their mood.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Not described Receives: Behavioral: Usual Care |
| Intervention group | Experimental | Not described Receives: Behavioral: Expressive Art Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9)
Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 consists of 9 items, with a total score ranging from 0 to 27. Higher scores indicate more severe depressive symptoms. The outcome evaluates the change in total score from baseline to mid-intervention, end of intervention, and 2-week follow-up.
Measured: Baseline up to Week 5 (including a 2- to 3-week intervention period and a 2-week follow-up)
Secondary outcomes (3)
Change from baseline in anxiety symptoms measured by the Generalized Anxiety Disorder-7 (GAD-7)
Anxiety symptoms will be assessed using the GAD-7 scale, with a total score ranging from 0 to 21 (higher scores indicate more severe symptoms). Assessments will be conducted at baseline, mid-intervention, end of intervention, and at a 2-week follow-up.
Measured: Baseline up to Week 5 (including a 2- to 3-week intervention period and a 2-week follow-up)
Change from baseline in alexithymia measured by the 20-item Toronto Alexithymia Scale (TAS-20)
Alexithymia will be assessed using the TAS-20, with a total score ranging from 20 to 100 (higher scores indicate greater severity). Assessments will be conducted at baseline, mid-intervention, end of intervention, and at a 2-week follow-up.
Measured: Baseline up to Week 5 (including a 2- to 3-week intervention period and a 2-week follow-up)
Change from baseline in positive psychological capital measured by the Positive Psychological Capital Questionnaire (PPQ)
Positive psychological capital will be assessed using the PPQ. Higher total scores indicate higher levels of positive psychological capital. Assessments will be conducted at baseline, mid-intervention, end of intervention, and at a 2-week follow-up.
Measured: Baseline up to Week 5 (including a 2- to 3-week intervention period and a 2-week follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start15 Nov 2026 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ningbo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junteng Tong, Ningbo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919288
- Sponsor's protocol ID
- NBU-2026-366
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Effectiveness of Expressive Arts Therapy in the Treatment of Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT07919288
- Acronym / sponsor ID
- NBU-2026-366
- Conditions
- Depression - Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ningbo UniversityUniversity, hospital or other
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 5 Nov 2026 (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 clinical trial is to learn whether expressive arts therapy works to treat major depressive disorder in adults. It will also learn about the safety and feasibility of expressive arts therapy. The main questions it aims to answer are:
- Can expressive arts therapy reduce depressive symptoms in participants with major depressive disorder?
- Can expressive arts therapy reduce alexithymia in participants with major depressive disorder?
- Can expressive arts therapy increase participants' positive psychological capital?
Researchers will compare expressive arts therapy with a control condition (such as usual care or a waitlist control) to see whether expressive arts therapy works to treat major depressive disorder.
Participants will:
- Receive expressive arts therapy sessions two or three times per week for 4 weeks, or receive the control condition
- Visit the clinic at scheduled intervals for checkups and assessments
- Complete questionnaires about depressive symptoms, alexithymia, and positive psychological capital
- Keep a diary of their mood and therapy-related experiences
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Behavioral: Usual Care |
| Intervention group | Experimental | Behavioral: Expressive Art Therapy |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 1. Male or female, aged between 16 and 60 years. 2. Clinically diagnosed with Major Depressive Disorder (MDD). 3. Score of ≥ 9 on the Patient Health Questionnaire-9 (PHQ-9) at baseline screening.
- 4. Currently receiving or taking antidepressant medication. 5. May have comorbid anxiety symptoms, but must have no history of alcohol or substance dependence.
- 6. Willing to participate in the study and able to provide written informed consent (for participants under 18, parental/guardian consent is required)
Key exclusion criteria (5 listed)
- Presence of severe psychiatric disorders other than MDD, or the duration of the current depressive episode is > 2 years (chronic depression).
- Planning to receive or currently receiving other formal psychological counseling or psychotherapy outside of this study during the research period.
- Score of < 9 on the PHQ-9 at baseline assessment.
- Presence of substance dependence (e.g., alcohol, drugs).
- Unwilling or unable to provide informed consent, or unable to complete the study assessments.
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 |
|---|---|---|
| Expressive Art TherapyParticipants in this group will receive structured expressive arts therapy sessions two or three times per week for 2 to 3 weeks. The sessions will be delivered by trained therapists, integrating various art modalities to help participants express emotions and process depressive experiences. Participants will complete questionnaires about depressive symptoms, alexithymia, and positive psychological capital at scheduled intervals, and keep a diary of their mood and therapy-related experiences. | Behavioural | Intervention group |
| Usual CareParticipants in the control group will receive their usual care for major depressive disorder, which may include standard pharmacotherapy and/or routine outpatient counseling. They will not receive expressive arts therapy during the study period. Participants will complete questionnaires about depressive symptoms, alexithymia, and positive psychological capital at the same scheduled intervals as the intervention group, and keep a diary of their mood. | Behavioural | control group |
Primary outcome
Change from baseline in depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline up to Week 5 (including a 2- to 3-week intervention period and a 2-week follow-up)
Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 consists of 9 items, with a total score ranging from 0 to 27. Higher scores indicate more severe depressive symptoms. The outcome evaluates the change in total score from baseline to mid-intervention, end of intervention, and 2-week follow-up.
3 secondary outcomes
Change from baseline in anxiety symptoms measured by the Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Baseline up to Week 5 (including a 2- to 3-week intervention period and a 2-week follow-up)
Change from baseline in alexithymia measured by the 20-item Toronto Alexithymia Scale (TAS-20)
Time frame: Baseline up to Week 5 (including a 2- to 3-week intervention period and a 2-week follow-up)
Change from baseline in positive psychological capital measured by the Positive Psychological Capital Questionnaire (PPQ)
Time frame: Baseline up to Week 5 (including a 2- to 3-week intervention period and a 2-week follow-up)
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 5 Nov 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Expressive Art Therapy in people with Depression - Major Depressive Disorder, run by Ningbo University.
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 3 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 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9) (time frame: Baseline up to Week 5 (including a 2- to 3-week intervention period and a 2-week follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2026; AzTrials last refreshed its copy on 5 Nov 2026.