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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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:
- 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Groupe d'intervention
|
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. |
|
Comparateur actif: groupe de contrôle
|
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change from baseline in depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9)
Délai: 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. |
Baseline up to Week 5 (including a 2- to 3-week intervention period and a 2-week follow-up)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change from baseline in anxiety symptoms measured by the Generalized Anxiety Disorder-7 (GAD-7)
Délai: Baseline up to Week 5 (including a 2- to 3-week intervention period and a 2-week follow-up)
|
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)
Délai: Baseline up to Week 5 (including a 2- to 3-week intervention period and a 2-week follow-up)
|
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)
Délai: Baseline up to Week 5 (including a 2- to 3-week intervention period and a 2-week follow-up)
|
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)
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- NBU-2026-366
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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