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临床试验/NCT07040852
NCT07040852尚未招募不适用

Development and Evaluation of a Mental Health Literacy Intervention in People With Chronic Pain

University of Coimbra1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
1
主要终点
change from Mental Health Literacy Scale

研究概览

简要总结

This pilot randomised controlled trial aims to assess the feasibility, acceptability, and preliminary efficacy of an intervention program promoting Mental Health Literacy. A 10-week group treatment, 90 minutes each session, for adults and older adults with Chronic Pain. Half of the participants will receive the intervention immediately (experimental group), while the other half will not receive it initially. Still, they will receive it after the main phase of the study is completed (control group in waiting list). The intervention focuses on increasing Mental Health Literacy and reducing maladaptive beliefs and behaviours associated with pain. It also explores mechanisms and moderators of change.

详细描述

Chronic pain is a public health problem that negatively affects well-being and quality of life. In addition to its physiological aspect, pain is a subjective, complex and multidimensional experience. Depression, anxiety, and distress are among the most potent and robust predictors of the transition from acute to chronic pain. Furthermore, maladaptive psychological processes are risk factors for and/or worsening of chronicity and/or intensification of pain symptoms. Therefore, intervention in chronic pain should be a multimodal approach.

Although psychological interventions, particularly Cognitive Behavioral Therapy, are moderately effective in the treatment of pain, the psychoeducational component integrated into these programs has been limited to the biopsychosocial nature of chronic pain and the relationship between psychological distress and pain symptoms, neglecting the promotion of well-being and flourishing. In fact, chronic pain interventions have been almost exclusively limited to reducing symptoms of pain and mental illness, and less so to promoting well-being and overall mental health.

Mental health literacy interventions significantly influence help-seeking behaviours. These interventions, particularly in school settings, show promise in reducing stigma and improving knowledge and attitudes related to mental health. Their efficacy can vary, and there is a need for more tailored approaches to meet the specific needs of individual people. Although Mental Health Literacy is receiving increasing attention as an emerging area of study, it has been an unexplored area in the context of chronic pain. The current study aims to determine the feasibility and evaluate the "Learn to Act" programme -a group-based, mental health literacy intervention in people with chronic pain.

This pilot study seeks to address the following specific research questions: To what extent can the study effectively recruit participants who meet the inclusion criteria? How feasible are the data collection procedures and outcome measures for reaching the target population and evaluating the study objectives? Are the intervention and study procedures acceptable to participants and appropriate for the intended context? Does the research team possess the necessary resources and operational capacity to manage and deliver the intervention effectively? Finally, is the intervention preliminarily effective in increasing mental health literacy, positive affect, satisfaction with life, and quality of life related to spirituality, religiousness and personal beliefs, while reducing pain catastrophising, pain intensity, pain interference, and negative affect? General study design - Participants previously diagnosed with Chronic Pain by a physician will be assigned to two different groups: an experimental group that receives the intervention immediately, and a control group that does not receive the intervention initially but will receive it after the main phase of the study is completed. The feasibility and preliminary efficacy of the Mental Health Literacy Promotion Intervention Program will be assessed by comparing the groups.

Sample: The study will recruit adults and older adults with Chronic Pain. Patients will be provided a study description, a consent form and the research team contact for further clarifications.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (18 to 64 years old) and seniors (65 years old or older) residing in Portugal.
  • Previous diagnosis of Chronic Pain carried out by a doctor.
  • Availability to attend sessions.

排除标准

  • Active neoplasia.
  • Inability to give informed consent (e.g. due to dementia).
  • Currently receiving psychological support regularly (sessions > once per semester).

结局指标

主要结局

change from Mental Health Literacy Scale

时间窗: baseline, immediately post-intervention, and 3-month follow-up

Mental Health Literacy - higher scores mean more Mental Health Literacy. Minimum value: 35 Maximum value: 160

change from Pain Catastrophizing Scale

时间窗: baseline, immediately post-intervention, and 3-month follow-up

Pain Catastrophizing - higher scores mean more catastrophizing thoughts are present. Minimum value: 0 Maximum value: 52

change from Brief Pain Inventory - intensity and interference

时间窗: baseline, immediately post-intervention, and 3-month follow-up

Pain intensity and interference - higher scores mean more perceived pain severity and interference. Minimum value: 0 Maximum value: 10

次要结局

  • Cognitive Failures Questionnaire(baseline)
  • change from World Health Organization Quality of Life - Spirituality, Religiousness and Personal Beliefs - Bref(baseline, immediately post-intervention, and 3-month follow-up)
  • change from Positive and Negative Affect Schedule(baseline, immediately post-intervention, and 3-month follow-up)
  • change from Satisfaction With Life Scale(baseline, immediately post-intervention, and 3-month follow-up)
  • change from Brief Religious and Spiritual Coping Scale(baseline, immediately post-intervention, and 3-month follow-up)
  • change from Meaning in Life Questionnaire(baseline, immediately post-intervention, and 3-month follow-up)
  • change from Pain Beliefs and Perceptions Inventory(baseline, immediately post-intervention, and 3-month follow-up)
  • Demographics Checklist(baseline)
  • Clinical Health Profile Checklist(baseline)
  • Neuropathic Pain Diagnostic Questionnaire(baseline)
  • Patient Global Impression of Change(immediately post-intervention and 3-month follow-up)

研究者

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

Bárbara Lyrio Ursine

PhD Candidate in Psychology

University of Coimbra

研究点 (1)

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