Is the Quality of the Therapeutic Alliance Associated With the Response to ChronoS Therapy? A Study in Patients With Mood Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Response to CHRONOS therapy
研究概览
简要总结
PREDI-CHRONOS is an ancillary study of the CHRONOS project (NCT07180290) The goal of this study is to measure the association between therapeutic alliance and the clinical response to the CHRONOS therapy.
The CHRONOS therapy is a new psychotherapy integrating:
- Interpersonal and Social Rhythm Therapy
- Chronotherapies to regulate sleep/wake cycles
- Positive mental imagery for stress management
- Mindfulness therapy for both stress and hyperarousal state management This therapy applied to patients with mood disorders (uni- or bipolar disorder). All participants in the study underwent the therapy. Response was defined as an improvement in the Insomnia Severity Index (ISI) from baseline to the end of the study.
The aim is to study the association of the therapeutic alliance with the response to the CHRONOS therapy, using the working alliance inventory (WAI) questionnaire.
Secondary objectives were to identify other factors potentially associated with the response to the therapy: history of a trauma, emotional regulation, and time perspective.
详细描述
Insomnia affects 85% of patients with a mood disorder during depressive phases and more than 50% will suffer from insomnia symptoms after remission. The treatment of insomnia with mood disorders represents a major therapeutic issue. European recommendations suggest that cognitive behavioural therapy for insomnia (iCBT) as the first-line reference treatment for chronic insomnia disorder. However, only 38% of patients respond positively to the treatment at 24 months, while 50% of patients with insomnia disorder and mood disorder do not respond to the treatment.
A new psychotherapy was developed within the Psychiatry, Sleep and Chronobiology Reference Center (ChronoS) integrating:
- Interpersonal and Social Rhythm Therapy
- Chronotherapies to regulate sleep/wake cycles
- Positive mental imagery for stress management
- Mindfulness therapy for both stress and hyperarousal state management The investigators designed a "before/after" study to evaluate the effectiveness of this psychotherapy with multimodal approaches on the severity of insomnia in patients with mood disorders (CHRONOS study, NCT07180290).
PREDI-CHRONOS is an ancillary study aiming at evaluating the association between therapeutic alliance and the clinical response to the CHRONOS therapy. Therapeutic alliance (or working alliance) can be defined as the collaborative relationship between patient and therapist based on purposeful collaboration and an affective bond. It is known to play an important role in therapeutic progress and treatment success.
Population: PREDI-CHRONOS included all patients that underwent the CHRONOS therapy (patients >= 18 years old, with mood disorders and an Insomnia Index Score >= 8, indicating the presence of insomnia). Patients under protection measures (curatorship) were not included in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years old with mood disorders diagnosed according to DSM-5 criteria
- •Patients with insomnia based on a ISI score >= 8
排除标准
- •Patients < 18 years old
- •Patients with psychotic disorders
- •Patients who have previously received cognitive therapy for insomnia
- •Patient subject to protective measures (curatorship)
结局指标
主要结局
Response to CHRONOS therapy
时间窗: Visit 1 : 1st session of the CHRONOS therapy (4 to 6 weeks after inclusion) Visit 2 : last session of the CHRONOS therapy (8 weeks after V1)
Response to therapy was measured by the Insomnia Severity Index (ISI). The score ranging from 17 to 84. A score above 7 indicating the presence of insomnia (score between 8-14 = insomnia symptoms of mild to moderate severity; score between 15-21 = insomnia symptoms of moderate severity; score between 22-28 = severe insomnia symptoms) An improvement in the ISI score between the beginning and the end of the therapy was considered as an effective response
Evaulation of therapeutic alliance
时间窗: Visit 1: 1st session of the CHRONOS therapy (4 to 6 weeks after inclusion) Visit 2: last session of the CHRONOS therapy (8 weeks after V1)
Therapeutic alliance was measured using the Working Alliance Inventory Short Revised (WAI-SR), a 12-item form, and scores ranging from 5 to 20. Higher scores indicate a better therapeutic alliance.
次要结局
- Emotional regulation(Visit 1 : 1st session of CHRONOS therapy (4 to 6 weeks after inclusion) Visit 2 : last session of CHRONOS therapy (8 weeks after V1))
- Presence of a trauma(Visit 1: 1st session of the CHRONOS therapy (4 to 6 weeks after inclusion))
- Time perspective(Visit 1: 1st session of CHRONOS therapy (4 to 6 weeks after inclusion))