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
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：介入群
|
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. |
|
アクティブコンパレータ：対照群
|
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline in depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9)
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline in anxiety symptoms measured by the Generalized Anxiety Disorder-7 (GAD-7)
時間枠：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)
時間枠：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)
時間枠：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)
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- NBU-2026-366
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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