Cognitive Therapy for Unipolar Depression: Efficacy of a Dilemma-Focused Intervention
調査の概要
状態
詳細な説明
Depression is one of the more severe and serious health problems because of its morbidity, disabling effects and for its societal and economic burden. Despite the variety of existing pharmacological and psychological treatments most of the cases evolve with only partial remission, relapse and recurrence.
Cognitive models made a significant contribution in the understanding of unipolar depression and its psychological treatment. Even though, success is only partial and many authors affirm the need to improve those models and also the treatment programs derived from them. One of the issues that requires further elaboration is the difficulty these patients experience in responding to treatment and in maintaining therapeutic gains across time without relapse or recurrence.
Our research group has been working in the notion of cognitive conflict viewed as personal dilemma according to personal construct theory. The investigators use a novel method for identifying those conflicts using the repertory grid technique. Preliminary results with depressive patients show that more than 90% of them have one or more of those conflicts. This fact might explain the blockage and the difficult progress of these patients, especially the more severe and/or chronic. These results justify the need for specific interventions focused in the resolution of these internal conflicts.
This study aims to empirically test the hypothesis that an intervention focused on the dilemma(s) specifically detected for each patient will contribute to enhance the efficacy of Cognitive-Behavioral Therapy for depression. A therapy manual for this approach will be tested using a randomized clinical trial by comparing the outcome of two treatment conditions: a CBT treatment package and another package combining cognitive-behavioral and dilemma-focused interventions. The investigators expect that this combined package will increase the efficacy of CBT, one of the more prestigious therapies for depression, this resulting in a significant contribution for its treatment.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Barcelona
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Mataro、Barcelona、スペイン、08304
- Hospital de Mataro (Consorci Sanitari del Maresme)
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Catalonia
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Barcelona、Catalonia、スペイン、08004
- CAP Les Hortes
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Barcelona、Catalonia、スペイン、08004
- Fundació Sanitària Sant Pere Claver
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Barcelona、Catalonia、スペイン、08032
- Associació Catalana de Teràpies Cognitives
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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:
- Meeting diagnostic criteria for Major Depressive Disorder (MDD) or Dysthymic Disorder (DD) according to the DSM-IV-TR (APA, 2002) criteria a assessed using SCID-I
- A score above 19 on the BDI-II Questionnaire
- Presenting at leat one cognitive conflict (implicative dilemma or dilemmatic construct) as assessed using the Repertory Grid Technique
- Enough level of competence to communicate in Spanish or Catalan
Exclusion Criteria:
- Bipolar disorders
- Psychotic symptoms
- Substance abuse
- Organic brain dysfunction
- Mental retardation
- Serious suicidal ideation
- Receiving psychological treatment (unless it is suspended at the time of inclusion in the study itself, in agreement with the patient and the practitioner applying it)
- Substantial visual, hearing or cognitive deficits
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：Cognitive Behavioral + Dilemma Therapy
Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention
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7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session.
Manualized.
他の名前：
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アクティブコンパレータ：Cognitive Behavioral Therapy
Combined Group and Individual Cognitive Behavioral Therapy
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Cognitive Behavioral Therapy for Depression.
Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session.
Manualized.
他の名前：
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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 |
|---|---|---|
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Change From Baseline in Beck Depression Inventory-Second Edition (BDI-II) at the End of Therapy, 3 and 12-month Follow-up
時間枠：End of therapy (16 weeks), 3 and 12-month follow-up
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To assess change in severity of depressive symptoms.
The Total score is reported, which is the sum of the ratings of all items and ranges from 0 to 63, with higher scores indicating more severity of depressive symptoms.
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End of therapy (16 weeks), 3 and 12-month follow-up
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline in Hamilton-Depression Rating Scale-17 Items
時間枠：End of therapy and 12-month follow-up
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This clinician-administered measure was only applied to 78 patients at pre- and posttreatment.
It measures severity of depressive symptoms.
The Total score is reported, which is the sum of the ratings of all items and ranges from 0 to 54, with higher scores indicating more severity of depressive symptoms.
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End of therapy and 12-month follow-up
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Change From Baseline in Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) at the End of Therapy, 3 and12 Month Follow-up
時間枠：End of therapy, 3 and 12 month follow-up
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To assess subjective well-being, symptoms or problems, life functioning, and risk.
The Total score is reported, which is the sum of the ratings of all items divided by the number of items (34).
The score and ranges from 0 to 4, with higher scores indicating more severity of psychological distress.
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End of therapy, 3 and 12 month follow-up
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協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Guillem Feixas, Ph.D.、University of Barcelona
出版物と役立つリンク
一般刊行物
- Feixas G, Bados A, Garcia-Grau E, Montesano A, Dada G, Compan V, Aguilera M, Salla M, Soldevilla JM, Trujillo A, Paz C, Botella L, Corbella S, Saul-Gutierrez LA, Canete J, Gasol M, Ibarra M, Medeiros-Ferreira L, Soriano J, Ribeiro E, Caspar F, Winter D. Efficacy of a dilemma-focused intervention for unipolar depression: study protocol for a multicenter randomized controlled trial. Trials. 2013 May 17;14:144. doi: 10.1186/1745-6215-14-144.
- Feixas G, Bados A, Garcia-Grau E, Paz C, Montesano A, Compan V, Salla M, Aguilera M, Trujillo A, Canete J, Medeiros-Ferreira L, Soriano J, Ibarra M, Medina JC, Ortiz E, Lana F. A DILEMMA-FOCUSED INTERVENTION FOR DEPRESSION: A MULTICENTER, RANDOMIZED CONTROLLED TRIAL WITH A 3-MONTH FOLLOW-UP. Depress Anxiety. 2016 Sep;33(9):862-9. doi: 10.1002/da.22510. Epub 2016 Apr 22.
- Feixas G, Paz C, Garcia-Grau E, Montesano A, Medina JC, Bados A, Trujillo A, Ortiz E, Compan V, Salla M, Aguilera M, Guasch V, Codina J, Winter DA. One-year follow-up of a randomized trial with a dilemma-focused intervention for depression: Exploring an alternative to problem-oriented strategies. PLoS One. 2018 Dec 13;13(12):e0208245. doi: 10.1371/journal.pone.0208245. eCollection 2018.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
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
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