ClinicalTrials.gg
Not yet recruitingNCT07919288Updated Nov 5, 2026

Expressive Arts Therapy in Major Depression: An RCT

An interventional study of Expressive Art Therapy and Usual Care in Depression - Major Depressive Disorder, sponsored by Ningbo University. Not yet recruiting. Open to participants aged 16 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Ningbo University · Not applicable, Interventional, and Treatment

Updated Nov 5, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
16 Years to 60 Years
Sex
All
01

Study 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. 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
02

Conditions studied

  • Depression - Major Depressive Disorder
03

In context

Depression

8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.

This study's planned enrollment of 120 is above the median of 81 across 7,063 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Ningbo University is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 (for participants under 18, parental/guardian consent is required)

Exclusion criteria

Exclusion Criteria:

  1. Presence of severe psychiatric disorders other than MDD, or the duration of the current depressive episode is > 2 years (chronic depression).
  2. Planning to receive or currently receiving other formal psychological counseling or psychotherapy outside of this study during the research period.
  3. Score of \< 9 on the PHQ-9 at baseline assessment.
  4. Presence of substance dependence (e.g., alcohol, drugs).
  5. Unwilling or unable to provide , or unable to complete the study assessments.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • Active comparator
    control group

    Behavioral: Usual Care

  • Experimental
    Intervention group

    Behavioral: Expressive Art Therapy

Interventions

  • BehavioralExpressive Art Therapy

    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.

  • BehavioralUsual Care

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline up to Week 5 (including a 2- to 3-week intervention period and a 2-week follow-up)

Secondary outcomes

  1. 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.

    Time frame: Baseline up to Week 5 (including a 2- to 3-week intervention period and a 2-week follow-up)

  2. 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.

    Time frame: Baseline up to Week 5 (including a 2- to 3-week intervention period and a 2-week follow-up)

  3. 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.

    Time frame: Baseline up to Week 5 (including a 2- to 3-week intervention period and a 2-week follow-up)

07

Study locations

No study locations are listed for this record.

08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Jan 2029, 25 months later.

Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 25 months is above that.

Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 30, 2026
First posted
Nov 5, 2026
StartEst.
Nov 15, 2026
Primary completionEst.
Jan 1, 2029
CompletionEst.
May 1, 2029
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07919288
Lead sponsor
Ningbo University
Responsible party
Junteng Tong (Undergraduate Student, Ningbo University) — Principal investigator
First posted
Nov 5, 2026
Start date
Nov 15, 2026 (estimated)
Primary completion
Jan 1, 2029 (estimated)
Completion
May 1, 2029 (estimated)
Last update
Nov 5, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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