Expressive Arts Therapy in Major Depression: An RCT

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?

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 Overview

• Status: Not yet recruiting
• Conditions: Depression - Major Depressive Disorder
• Intervention / Treatment: Behavioral: Usual Care; Behavioral: Expressive Art Therapy

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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 informed consent, or unable to complete the study assessments.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group	Behavioral: Expressive 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.
Active Comparator: control group	Behavioral: Usual 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline up to Week 5 (including a 2- to 3-week intervention period and a 2-week follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline up to Week 5 (including a 2- to 3-week intervention period and a 2-week follow-up)

Collaborators and Investigators

• Sponsor: Ningbo University

Study record dates

Study Major Dates

• Study Start (Estimated): November 15, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: October 30, 2026
• First Submitted That Met QC Criteria: October 30, 2026
• First Posted (Actual): November 5, 2026

Study Record Updates

• Last Update Posted (Actual): November 5, 2026
• Last Update Submitted That Met QC Criteria: October 30, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: NBU-2026-366

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No