Learn to Act - Promoting Mental Health Literacy in Chronic Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Coimbra
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Active neoplasia.
Inability to give informed consent (e.g. due to dementia).
Currently receiving psychological support regularly (sessions > once per semester).
Trial design
Design model
Parallel
Treatments tested in this trial
Mental Health Literacy Promotion Intervention Program
Behavioral10 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Mental Health Literacy Promotion Intervention ProgramExperimental treatment 1 intervention
Group B: Waitlist ControlOther 1 intervention
Trial outcomes
Primary outcomes
1
change from Mental Health Literacy Scale
Mental Health Literacy - higher scores mean more Mental Health Literacy. Minimum value: 35 Maximum value: 160
Time frame
baseline, immediately post-intervention, and 3-month follow-up2
change from Pain Catastrophizing Scale
Pain Catastrophizing - higher scores mean more catastrophizing thoughts are present. Minimum value: 0 Maximum value: 52
Time frame
baseline, immediately post-intervention, and 3-month follow-up3
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
Time frame
baseline, immediately post-intervention, and 3-month follow-upSecondary outcomes
1
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
Time frame
baseline, immediately post-intervention, and 3-month follow-up2
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
Time frame
baseline, immediately post-intervention, and 3-month follow-up3
change from Satisfaction With Life Scale
Satisfaction With Life - higher scores mean more Satisfaction With Life. Minimum value: 5 Maximum value: 35
Time frame
baseline, immediately post-intervention, and 3-month follow-up4
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.
Time frame
baseline, immediately post-intervention, and 3-month follow-upSponsors and contacts
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Source ClinicalTrials.gov
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