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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Interventionsgruppe
|
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. |
|
Aktiver Komparator: Kontrollgruppe
|
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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change from baseline in depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9)
Zeitfenster: 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)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change from baseline in anxiety symptoms measured by the Generalized Anxiety Disorder-7 (GAD-7)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- NBU-2026-366
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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