精神疾患患者の非公式介護者のための早期介入を目的としたアンサンブル プログラム (Ensemble)
精神病患者の非公式介護者のための早期介入アンサンブル プログラム: ランダム化比較試験
This study focuses on the difficulties of maintaining optimal psychological health and quality of life for caregivers in adult psychiatry while they play an important role in helping patients with severe psychiatric disorders. It evaluates the addition of a 5 session psychological program, named Ensemble. Half of the participants will receive their usual support and Ensemble in combination, while the other half will receive usual support only.
調査の概要
詳細な説明
The recent statistics showed that mental disorders affect one in four people in the world. In this context, informal caregivers are key actors in the health care system through their support. This support can be associated with very high burden and distress. Informal caregivers can experience serious situations with potential negative consequences on their quality of life, their own health and the health of patients. Data recommended to intervene at the onset of disease to improve the impact of an intervention. It seems important also to intervene while the patient is in an acute phase of illness to better support informal caregivers' emotional needs. In addition, providing emotional support for informal caregivers at the beginning of an illness in particular is recommended because this is a critical phase. The experience of painful emotions, such as denial of disease and feelings of being overwhelmed or shocked can have serious consequences on their health and on the patient's recovery. Previous studies identified that informal caregivers need tailored knowledge about the patient's illness, clarification about their roles and responsibilities, better control over their own life and effective collaboration with health professionals. Most of the interventions published in the literature focus on the ill family member and its support but not on the specific needs of the informal caregivers as the core intervention. To reduce the gap between scientific recommendations and actual practice, the investigators developed, tailored and tested a new intervention called Ensemble.
Ensemble is a brief individualized intervention designed to promote the well-being of informal caregivers who experience the effects of patients' psychiatric disorders. The five-session Ensemble program provided to informal caregivers targeted support to address their specific unmet needs, emotions and social resources. A professional addressed this programme to the informal caregiver delivered independently of the patient's treatment.
Ensemble assesses the needs of informal caregivers and provides a tailored brief support. Results of a pilot study showed that psychological health and optimism of informal caregivers were improved. For these reasons, there is a clear research and clinical need to establish whether Ensemble programme is clinically effective by using a randomized, controlled, and assessor-blind trial. A combination of Ensemble plus support as usual (SAU) will be compared to SAU alone. Informal caregivers of individuals suffering from mental disorders will undergo either intervention for five sessions, during a six weeks average time. Measure will assess participants' current psychological health state and optimism. These different measures will be performed at the time of inclusion, at the end of the intervention, and at two months follow-up. At the end of the program, individual qualitative structured interviews will be performed to assess acceptability of the programme.
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
-
-
Canton of Vaud
-
Lausanne、Canton of Vaud、スイス、1004
- La Source, School of Nursing Sciences, HES-SO University of Applied Sciences Western Switzerland, Lausanne.
-
-
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:
- Being at least 18 years old
- Living in the French-speaking cantons of Switzerland (commonly referred to as "Romandy")
- Speaking French
- Having an adult relative suffering from a psychiatric disorder (with or without an established diagnosis)
- Having the capacity to agree to participate in the project
Exclusion Criteria:
- Having les than 20 on the Zarit score.
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：支持療法
- 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 |
|---|---|
|
実験的：Ensemble + SAU (Support as usual)
The five-session Ensemble program provided to informal caregivers targeted support + SAU |
Ensemble is a individualized programme to address informal caregiver's specific unmet needs, emotions and social resources, in order to offer a targeted support in five sessions.
他の名前：
Informal caregivers have often to manage the situation in usual different ways. Support as usual (SAU) alone consists of an informal support by patient's clinical team. Specific psychoeducational programs depending on patient's illnes (like "Profamille" for schizophrenia) or peer-support depending to the voluntary work of families' associations. Some general professional services focused on informal caregivers or relatives in order to inform and orient them if they are avaible in the study area. No attempts have been made to standardize this treatement as SAU depend to informal caregiver's need and knowledge of the health system, also her/his capacity or possibility to be in contact with patient's clinical team.
他の名前：
|
|
アクティブコンパレータ：SAU (Support as usual)
SAU alone which was chosen as a control condition. |
Informal caregivers have often to manage the situation in usual different ways. Support as usual (SAU) alone consists of an informal support by patient's clinical team. Specific psychoeducational programs depending on patient's illnes (like "Profamille" for schizophrenia) or peer-support depending to the voluntary work of families' associations. Some general professional services focused on informal caregivers or relatives in order to inform and orient them if they are avaible in the study area. No attempts have been made to standardize this treatement as SAU depend to informal caregiver's need and knowledge of the health system, also her/his capacity or possibility to be in contact with patient's clinical team.
他の名前：
|
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 |
|---|---|---|
|
General Distress by Global Severity Index
時間枠：Baseline, T1 at 2 months, and T2 at 4 months
|
The Brief Symptom Inventory (BSI) invlude normative data to detect clinical symptoms as indicators of emotional distress, with 53 items on a 5-point Likert-type scale (0-4), ranging from "not at all"=0 to "extremely=4." The items measure physical and psychological symptoms occurring in the preceding 7-day period. It includes three global indices: Global Severity Index (GSI, indicating the global distress level), Positive Symptom Total (PST, indicating the number of symptoms an individual reports) and Positive Symptom Distress Index (PSDI, indicating the average distress level).The Global Severity Index (GSI) is a composite score to measure global distress Min = 0; Max=212: Range 0-3.83, a higher score reprensent a severer global distress level. The interpretation |
Baseline, T1 at 2 months, and T2 at 4 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Optimism Level
時間枠：Baseline, T1 at 2 months, and T2 at 4 months
|
Assessement of optimism level (LOT-R scale). The Life Orientation Test - Revised (LOT-R) measures an individual's optimism regarding a given situation. This scale includes 10 items; three items measure optimism, three other measure pessimism, and four of the 10 items function as fillers. Items are answered by a Likert-type of scale which varies from 0 (strongly disagree) to 4 (strongly agree). LOT-R score can range from 0 to 24, Min=0, Max=40; 0-13 Low Optimism (High Pessimism); 14-18 Moderate Optimism; 19-24 High Optimism (Low Pessimism). Higher values represent better outcome. |
Baseline, T1 at 2 months, and T2 at 4 months
|
|
Quality of Live - Mental Dimension
時間枠：Baseline, T1 at 2 months, and T2 at 4 months
|
36-item Medical Outcome Study Short-Form Health Survey (SF-36) measures health indicators related to the quality of life by 36 items, used in clinical and general population settings to evaluated eight health dimensions: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Higher score defines a more favorable health state. Each item is scored on a 0 to 100 range, 0 being the lowest and 100 being the highest possible scores.Two global scores, i) A Physical Component Score (PCS) and ii) the Mental Component Score (MCS) obtained by grouping dimensions to have global variables (min=0; max =400). MCS is the addition of the mean scores on the emotional well-being, social functioning,vitality and emotional limitation subscales. Lower MCS scores potentially indicate presence of psychological risk. |
Baseline, T1 at 2 months, and T2 at 4 months
|
|
Burden Level
時間枠：Baseline, T1 at 2 months, and T2 at 4 months
|
Assessment of the informal caregiver's burden level by the Zarit Burden Interview. This 22-item scale assesses the subjective burden (emotional, physical and financial) for an informal caregiver of an individual with loss of autonomy. The score is obtained by the addition of the 22 items. Scores range between 0 and 88, 61-88 is considered as a high burden, 41-60 is a moderate to high burden, 21-40 is a light to moderate burden and 0-20 is considered as no subjective burden. |
Baseline, T1 at 2 months, and T2 at 4 months
|
|
Patient's Social an Occupational Functioning
時間枠：Baseline and T2 at 4 months
|
Social and Occupational Functioning Assessment Scale (SOFAS) is a scale from 0 to 100 demonstrating the patient's social functioning. In this study, this score will be measured according to the informal caregiver's representation. It is used in psychiatry to evaluate how well a patient is functioning in daily life, work, and social relationships.High scores (≥70) indicate good to excellent functioning; Moderate scores (50-69) suggest some difficulties but still some level of independence; Low scores (<50) indicate serious impairments in daily life, often requiring intervention |
Baseline and T2 at 4 months
|
協力者と研究者
捜査官
- 主任研究者：Shyhrete Rexhaj、Institut et Haute école de la Santé, La Source
出版物と役立つリンク
一般刊行物
- Rexhaj S, Monteiro S, Golay P, Coloni-Terrapon C, Wenger D, Favrod J. Ensemble programme for early intervention in informal caregivers of psychiatric adult patients: a protocol for a randomised controlled trial. BMJ Open. 2020 Jul 30;10(7):e038781. doi: 10.1136/bmjopen-2020-038781.
- Rexhaj S, Nguyen A, Favrod J, Coloni-Terrapon C, Buisson L, Drainville AL, Martinez D. Women involvement in the informal caregiving field: A perspective review. Front Psychiatry. 2023 Jan 18;14:1113587. doi: 10.3389/fpsyt.2023.1113587. eCollection 2023.
- Rexhaj S, Martinez D, Golay P, Coloni-Terrapon C, Monteiro S, Buisson L, Drainville AL, Bonsack C, Ismailaj A, Nguyen A, Favrod J. A randomized controlled trial of a targeted support program for informal caregivers in adult psychiatry. Front Psychiatry. 2023 Nov 30;14:1284096. doi: 10.3389/fpsyt.2023.1284096. eCollection 2023.
研究記録日
主要日程の研究
研究開始 (実際)
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 (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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。