Executive Summary of the Proposed Pilot Study
Executive Summary of the Proposed Pilot Study
Longitudinal Observational Study of Mental Health and Addiction Recovery Outcomes in Brazilian Therapeutic Communities
This proposed pilot study is designed to evaluate mental health, addiction recovery and psychosocial outcomes among adults receiving care through participating Brazilian therapeutic communities and mental health organizations. The study would be prospective, longitudinal, observational and non-interventional.
Purpose of the Pilot Study
The pilot is intended to determine whether structured longitudinal research can be implemented responsibly in participating community-based recovery settings.
It would also help characterize the study population, evaluate data-collection procedures, assess participant retention and identify factors associated with relapse and sustained recovery.
Primary Research Question
How do mental health, substance use, psychological functioning, quality of life, family relationships, social reintegration and recovery outcomes change over time among adults receiving care in participating Brazilian therapeutic communities?
Primary Objective
To evaluate longitudinal changes in addiction recovery, mental health and psychosocial functioning from admission through treatment and, whenever feasible, after discharge.
Secondary Objectives
- ✦ Describe participant characteristics at admission
- ✦ Measure treatment retention and adherence
- ✦ Evaluate craving and relapse
- ✦ Monitor depression and anxiety
- ✦ Assess quality of life
- ✦ Examine emotional regulation
- ✦ Evaluate family and social reintegration
- ✦ Explore spirituality and meaning
- ✦ Assess outcomes after discharge
- ✦ Evaluate the feasibility of digital follow-up
Proposed Study Design
Type
Prospective longitudinal observational study.
Intervention
No experimental treatment assignment.
Setting
Participating therapeutic communities and mental health organizations in Brazil.
Population
Adults receiving care for substance use disorders and capable of providing informed consent.
Proposed Participant Profile
The pilot may include adults receiving care for alcohol or other substance use disorders through approved partner institutions. Participation would be voluntary and separate from access to treatment or community services.
- ✦ Adult participants
- ✦ Capacity to provide informed consent
- ✦ Current participation in an approved recovery program
- ✦ Willingness to complete follow-up assessments
- ✦ Ability to communicate relevant health and recovery information
Potential Assessment Schedule
The final schedule may be adjusted according to treatment duration, institutional capacity and participant availability.
Proposed Outcome Areas
Substance Use
Craving, relapse and continued recovery.
Mental Health
Depression, anxiety and psychological distress.
Treatment Engagement
Retention, adherence and participation.
Psychological Functioning
Emotional regulation, coping and psychological flexibility.
Quality of Life
Physical, emotional, social and environmental well-being.
Social Reintegration
Family relationships, employment, social support and community participation.
Cognitive Functioning
Attention, memory, decision-making and executive functioning.
Spirituality and Meaning
Belonging, personal values, meaning in life and spiritual resources.
Potential Data Collection Methods
The study may combine validated questionnaires, structured interviews, participant-reported outcomes, institutional records and qualitative interviews. Digital systems may support symptom monitoring, routine follow-up and participant engagement. Digital tools should support, not replace, direct professional care or clinical assessment.
Ethics and Participant Protection
- ✦ Voluntary informed consent
- ✦ Right to decline or withdraw
- ✦ No effect on access to care
- ✦ Protection from coercion
- ✦ Confidentiality
- ✦ Secure data storage
- ✦ Data minimization
- ✦ Protection of vulnerable participants
- ✦ Independent ethical review
- ✦ Clear referral procedures when concerns are identified
Non-Interventional Initial Phase
The proposed pilot would not involve experimental administration of psychedelic substances.
Its purpose is to develop a reliable observational foundation for mental health and addiction recovery research.
Any future interventional study would require a separate protocol, qualified medical and academic leadership, ethical approval, regulatory authorization and appropriate clinical infrastructure.
Expected Value of the Pilot
- ✦ Test research feasibility
- ✦ Improve longitudinal monitoring
- ✦ Identify retention challenges
- ✦ Describe recovery trajectories
- ✦ Generate preliminary data
- ✦ Support future protocol development
- ✦ Strengthen professional training
- ✦ Inform larger multicenter studies
- ✦ Create opportunities for scientific publication
Potential Partner Contributions
Academic and institutional partners may contribute to study design, instrument selection, ethics, statistics, data management, addiction medicine, neuropsychology, qualitative methods and scientific publication.
Brazilian institutions and professionals should participate in implementation, interpretation, authorship and dissemination.
Proposed Next Steps
Academic and community partners.
Finalize primary and secondary objectives.
Choose validated assessment tools.
Develop data management and protection procedures.
Formal submission before any recruitment.
Invitation to Collaborate
PSICODELIX welcomes dialogue with universities, hospitals, researchers, foundations and institutions interested in addiction recovery, therapeutic communities, longitudinal research and community mental health.
The immediate objective is to refine the pilot, identify qualified partners and develop an ethically appropriate research protocol.
Contact for Institutional Collaboration