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临床试验/NCT06054061
NCT06054061已完成不适用

Improving Subjective Wellbeing Despite a Severe Psychiatric Condition Through "Think and Cope Positively" Program: A Randomized Control Trial.

Universidad Pontificia Comillas2 个研究点 分布在 1 个国家目标入组 449 人开始时间: 2023年9月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
449
试验地点
2
主要终点
Satisfaction with life scale (SWLS)

研究概览

简要总结

The purpose of this study is to determine whether an integrated protocol based on cognitive behavioural therapy, positive psychology and third generation therapies is effective in improve the subjective well-being of people affected by a severe mental illness (SMI).

The design of the study is a cluster randomized control trial with two arms. Experimental groups will receive 15 sessions to enhance positive emotions, optimism, adaptive coping, finding a purpose in life and sharing it with people who are important to the user. The control group will remain on a waitlist with their treatment as usual (TAU). After the control period (15 weeks), participants of the experimental groups have the chance to receive the intervention. Both groups will be measure before and after de 15 intervention weeks. Additionally, follow-up measures of the experimental group will be taken after 3 and 6 months.

详细描述

This research aims to generate evidence on the usefulness of interventions focused on the well-being of people diagnosed with SMI, trying to alleviate some of the limitations found in previous protocols.

Regarding the content of the sessions, optimism, low levels of depression, social support and the degree of agreement with the therapist, have recently been identified as the factors that best predict subjective well-being in people affected by SMI. Therefore, modules on optimism and coping focused on well-being will be included, maintaining the emphasis of the work on positive emotions. By adding an individual work session in which goals and objectives are agreed upon by the therapist and user, the consensus will be strengthened between both parties. After discussing the construction of a life project throughout the protocol, the process the process will conclude with a session combined users and the special persons chosen by the participants. Both members will have the opportunity to share with each other.

Finally, we will follow the indications of recent studies which demonstrate that, in order to improve the optimistic response in psychiatric populations, it is necessary to reformulate negative thinking, practice hopeful thinking, practice gratitude and build a life project.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Users of public psychosocial rehabilitation resources belonging to the Community of Madrid and Castilla la Mancha
  • Legal age
  • Clinical diagnosis of severe mental disorder: schizophrenia spectrum, bipolar disorder, personality disorders and severe affective disorders.
  • Psychopathological stability (or that residual symptoms do not interfere with the course of treatment)
  • Minimum level of cognitive comprehension (i.e. no comorbidity with intellectual disability).

排除标准

  • Addiction dependence criteria (on the other hand, people with substance abuse criteria will be accepted)
  • Altered behavior (relationally) that could alter the good functioning of the group.
  • Prior to their participation in the study, the rehabilitation team, in coordination with the research team, will assess whether the patient can benefit from the study.

研究组 & 干预措施

TAU + waiting list

Other

The control group will continue to receive the treatment as usual in their intervention resources. At the end of the 15-week control period they will receive the intervention.

干预措施: TAU (Behavioral)

TAU + Wellbeing promotion group (Think and Cope Positively) Intervention

Experimental

In addition to their usual treatment, participants form the experimental arm will receive 15 weekly intervention sessions, where aspects related to subjective wellbeing, life plans, alliance with the therapist or family and social relationships will be worked on.

干预措施: TAU (Behavioral)

TAU + Wellbeing promotion group (Think and Cope Positively) Intervention

Experimental

In addition to their usual treatment, participants form the experimental arm will receive 15 weekly intervention sessions, where aspects related to subjective wellbeing, life plans, alliance with the therapist or family and social relationships will be worked on.

干预措施: Experimental: experimental wellbeing promotion group (Think and Cope Positively) (Behavioral)

结局指标

主要结局

Satisfaction with life scale (SWLS)

时间窗: This test is applied before starting the intervention protocol, immediately after the end of the 15-week intervention protocol, and at 3 and 6 months after the end of the intervention protocol.

The scale evaluate hedonic well-being by 5 items with a 7-point Likert-type response scale (strongly disagree - strongly agree). Mean scores range from 1 to 5. Higher scores indicates higher hedonic well being.

Psychological Well-being Scale (SPWB)

时间窗: This test is applied before starting the intervention protocol, immediately after the end of the 15-week intervention protocol, and at 3 and 6 months after the end of the intervention protocol.

The scale evaluate eudaemonic well-being by 29 items with a Likert-type scale from 1 to 6 (totally disagree - totally agree). The scale measures 6 domains of well being (self-acceptance, purpose in life, personal growth, positive relationships, autonomy and mastery of the environment). Mean scores range from 1 to 6. Higher scores indicates higher eudaemonic well being or domain.

次要结局

  • Therapeutic Alliance and Theory of Change Inventory (WATOCI)(This test is applied before starting the intervention protocol, immediately after the end of the 15-week intervention protocol, and at 3 and 6 months after the end of the intervention protocol.)
  • Openness to the Future Scale (OFS)(This test is applied before starting the intervention protocol, immediately after the end of the 15-week intervention protocol, and at 3 and 6 months after the end of the intervention protocol.)
  • Symptom Checklist-45 abbreviated version(This test is applied before starting the intervention protocol, immediately after the end of the 15-week intervention protocol, and at 3 and 6 months after the end of the intervention protocol.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rocio Caballero Campillo

Assistant Collaborator - Clinical Professor

Universidad Pontificia Comillas

研究点 (2)

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