Chronic PainNCT07040852
Learn to Act - Promoting Mental Health Literacy in Chronic Pain
A study testing Mental Health Literacy Promotion Intervention Program in people with Chronic Pain and Mental Health, run by University of Coimbra at 1 site in Portugal.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Mental Health, Health Literacy
- What is being tested?
- Mental Health Literacy Promotion Intervention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePortugal
- Study dates
- Sep 2025to May 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Active neoplasia.
- Inability to give informed consent (e.g. due to dementia).
- Currently receiving psychological support regularly (sessions > once per semester).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site
Pain Unit/ Anesthesiology Service/ Coimbra Local Health Unit
Coimbra
Teresa Lapa, teresalapa@hotmail.com
About this study
Official title: Development and Evaluation of a Mental Health Literacy Intervention in People With Chronic Pain
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.
Read the detailed description
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.
The Mental Health Literacy Promotion Intervention Program has the following goals: (a) improve understanding of the pain-mental health connection, (b) reduce mental health stigma, (c) recognize symptoms of mental health challenges, and (d) encourage help-seeking behaviours.
Primary outcomes include changes in Mental Health Literacy and pain catastrophising. Secondary outcomes include quality of life, well-being, satisfaction with life, and pain interference/intensity. The study will assess feasibility through recruitment and retention rates, session attendance, and participant feedback. Mediators and moderators such as pain beliefs, religious coping, meaning in life, and demographic or clinical factors will also be explored to understand the process of change and differential responsiveness.
- Conditions
- Chronic Pain, Mental Health, Health Literacy
- Being tested
- Mental Health Literacy Promotion Intervention Program
- Keywords
- Chronic Pain, Mental Health Literacy, Health Literacy, Mental Health, pain education
- Medical subject headings
- Chronic Pain, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental Health Literacy Promotion Intervention ProgramBehavioural
10 sessions, 90 minutes each, weekly. A face-to-face group treatment for Chronic Pain that focuses on enhancing individuals' understanding of mental health issues, promoting help-seeking behaviors, and reducing stigma associated with mental illness. Intervention includes group discussions, audio-visual material and written material.
| Study group | Role | What they receive |
|---|---|---|
| Mental Health Literacy Promotion Intervention Program | Experimental | The Intervention Program promoting Mental Health Literacy in people with Chronic Pain is based on the state of the art of Educational Interventions and Mental Health promotion Interventions. Receives: Behavioral: Mental Health Literacy Promotion Intervention Program |
| Waitlist Control | Other | Receives intervention later, after initial data collection. Receives: Behavioral: Mental Health Literacy Promotion Intervention Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from Mental Health Literacy Scale
Mental Health Literacy - higher scores mean more Mental Health Literacy. Minimum value: 35 Maximum value: 160
Measured: baseline, immediately post-intervention, and 3-month follow-up
change from Pain Catastrophizing Scale
Pain Catastrophizing - higher scores mean more catastrophizing thoughts are present.
Minimum value: 0 Maximum value: 52
Measured: baseline, immediately post-intervention, and 3-month follow-up
change from Brief Pain Inventory - intensity and interference
Pain intensity and interference - higher scores mean more perceived pain severity and interference.
Minimum value: 0 Maximum value: 10
Measured: baseline, immediately post-intervention, and 3-month follow-up
Secondary outcomes (11)
change from World Health Organization Quality of Life - Spirituality, Religiousness and Personal Beliefs - Bref
Quality of Life Spiritual, Religious and Personal Beliefs - higher scores mean a more positive perception of quality of life in the dimensions of spirituality, religiosity and personal beliefs.
Minimum value: 9 Maximum value: 45
Measured: baseline, immediately post-intervention, and 3-month follow-up
change from Positive and Negative Affect Schedule
Positive and Negative Affect - higher scores mean more attribution of positive or negative Affect, respectively.
Minimum value (per subscale): 10 Maximum value (per subscale): 50
Measured: baseline, immediately post-intervention, and 3-month follow-up
change from Satisfaction With Life Scale
Satisfaction With Life - higher scores mean more Satisfaction With Life. Minimum value: 5 Maximum value: 35
Measured: baseline, immediately post-intervention, and 3-month follow-up
change from Brief Religious and Spiritual Coping Scale
Religious and spiritual coping strategies in response to stress and illness.
- Positive Religious Coping Score (7-28): Higher scores indicate greater reliance on adaptive spiritual coping.
- Negative Religious Coping Score (7-21): Higher scores reflect significant spiritual struggle and maladaptive coping.
Measured: baseline, immediately post-intervention, and 3-month follow-up
change from Meaning in Life Questionnaire
Presence of Meaning and Search for Meaning - higher scores indicate greater attribution of Presence of Meaning or Search for Meaning, respectively.
Minimum value (per subscale): 1 Maximum value (per subscale): 25
Measured: baseline, immediately post-intervention, and 3-month follow-up
change from Pain Beliefs and Perceptions Inventory
Pain Beliefs and Perceptions - higher scores mean more attribution of organic or psychological causes of pain.
Minimum value: 15 Maximum value: 90
Measured: baseline, immediately post-intervention, and 3-month follow-up
Demographics Checklist
Gender, age, education level, spirituality/religiousness will be assessed as potential moderators of the intervention's efficacy. These factors may help identify subgroups that respond differently to the intervention.
Measured: baseline
Clinical Health Profile Checklist
Professional healthcare follow-up, comorbid conditions, and pain duration will be assessed as potential moderators of the intervention's efficacy. These factors may help identify subgroups that respond differently to the intervention.
Measured: baseline
Neuropathic Pain Diagnostic Questionnaire
Neuropathic Pain - higher scores mean greater likelihood of neuropathic pain. Minimum value: 0 Maximum value: 7
Measured: baseline
Cognitive Failures Questionnaire
Cognitive Failures - higher scores mean more Cognitive Failures. Minimum value: 0 Maximum value: 100
Measured: baseline
Patient Global Impression of Change
Patient's overall perception of change in their health status - higher scores mean the patient's perception that there has been a substantial improvement in their health.
Minimum value: 1 Maximum value: 7
Measured: immediately post-intervention and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study startSep 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bárbara Lyrio Ursine, University of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040852
- Sponsor's protocol ID
- 2023.02028.BD
- Other IDs
- 2023
- Status last verified
- Jun 2025
- First submitted
- 16 Jun 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No