Learn to Act - Promoting Mental Health Literacy in Chronic Pain

NCT07040852 | Not Yet Recruiting

• 1 other identifier: 2023.02028.BD
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Pain; Mental Health; Health Literacy

Keywords

Chronic Pain; Mental Health Literacy; Health Literacy; Mental Health; pain education

Outcome Measures

Primary Outcomes (3)

• change from Mental Health Literacy Scale

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

  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

  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

  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

  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

Study Arms (2)

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.

Behavioral: Mental Health Literacy Promotion Intervention Program

Waitlist Control

OTHER

Receives intervention later, after initial data collection.

Behavioral: Mental Health Literacy Promotion Intervention Program

Interventions

Mental Health Literacy Promotion Intervention Program BEHAVIORAL

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.

Mental Health Literacy Promotion Intervention Program; Waitlist Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Coimbra: lead

Study Sites (1)

Pain Unit/ Anesthesiology Service/ Coimbra Local Health Unit

Coimbra, Portugal

Location

MeSH Terms

Conditions

Chronic Pain; Psychological Well-Being

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior

Central Study Contacts

Bárbara Ursine

CONTACT

+351 910 773 960; barbaraursine@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate in Psychology

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 27, 2025
• Study Start: September 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: May 1, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)