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
Przegląd badań
Status
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Grupa interwencyjna
|
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. |
|
Aktywny komparator: Grupa kontrolna
|
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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change from baseline in depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9)
Ramy czasowe: 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)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change from baseline in anxiety symptoms measured by the Generalized Anxiety Disorder-7 (GAD-7)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- NBU-2026-366
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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