- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07058532
- Original Trial
Therapeutic Writing for Adults Suffering From Chronic Pain and Comorbid Mental Health Disorders (TWfCP&MH)
Therapeutic Writing Intervention in Pain Rehabilitation
The goal of this observational study is to understand the effects and experiences of therapeutic writing interventions in adult women with chronic pain and co-occurring mental health conditions. The main questions it aims to answer are:
Can therapeutic writing help relieve chronic pain and emotional distress?
How does writing support emotional processing, regulation, and meaning-making during rehabilitation?
Participants will take part in a two-part writing intervention involving:
Guided writing exercises that focus on emotional processing, emotion regulation, and creating meaning.
Individual interviews after the writing sessions to explore their experiences.
The study uses qualitative analysis methods-phenomenology and logotherapy-to better understand how these writing interventions may support recovery, improve well-being, and offer non-pharmacological tools for managing chronic pain and mental health challenges.
Study Overview
Status
Conditions
- Depressive Disorder
- Chronic Pain
- Sleep Disorder
- Anxiety Disorders
- Mental Health Disorder
- Emotional Distress
- Emotion Regulation
- Psychiatric Diagnosis
- Meaning of Life and Life Satisfaction
- Meaning of Life
- Process, Acceptance
- Psychiatric Comorbidities
- Comorbid Depression
- Emotional Pain
- Emotional Processing
- Meaning Made
- Psychiatric &Amp;Amp;or Mood Disorder
Intervention / Treatment
Detailed Description
Chronic pain affects approximately 20% of the global population and represents one of the most widespread causes of disability worldwide. Individuals living with chronic pain often experience additional mental health challenges-such as depression, anxiety, or trauma-related disorders-which compound their suffering and reduce quality of life. Traditional pain management strategies often focus on physical symptoms, while the emotional and psychological dimensions may remain under-addressed.
This study aims to explore the potential of therapeutic writing-a psychological intervention that encourages participants to express and process emotions through guided writing exercises-as a complementary approach for improving health and well-being in individuals with both chronic pain and mental health conditions.
The study is being conducted at the Department of Physical Medicine and Rehabilitation of Satasairaala Hospital in Finland and involves five adult female participants with chronic pain and comorbid psychiatric conditions. Each participant will engage in a two-part writing intervention that incorporates techniques grounded in emotional processing, emotion regulation, and meaning-making. These exercises are designed to help individuals articulate their internal experiences, explore the personal impact of pain and illness, and foster a sense of psychological coherence.
Data collection spans two sub-studies:
Sub-studies 1 and 2 involve qualitative interviews with participants following the intervention, capturing their firsthand experiences and perceived effects.
The qualitative data will be analyzed using a multi-method approach, combining phenomenological analysis-which highlights the participants' lived experiences-and logotherapy-informed analysis, which examines how therapeutic writing supports the search for meaning during rehabilitation. This dual approach provides a comprehensive view of how narrative expression may influence recovery pathways.
The ultimate goal is to identify writing-based strategies that can complement clinical care for this patient population and inform future updates to rehabilitation programs and treatment guidelines-both locally and nationally. If proven beneficial, therapeutic writing could serve as an accessible, cost-effective, and non-pharmacological tool to enhance holistic pain care and mental health support.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Toni Salikka, MA, PhD Candidate
- Phone Number: +358453046569
- Email: toni.salikka@tuni.fi
Study Contact Backup
- Name: University Lecturer, PhD
- Phone Number: +358401901623
- Email: sari.frojd@tuni.fi
Study Locations
-
-
Satakunta
-
Pori, Satakunta, Finland, 28500
- Satasairaala Hospital, Department of Physical Medicine and Rehabilitation: Pain Clinic
-
Contact:
- Chief Medical Officer and Physician, MD, PhD
- Phone Number: +35844707330
- Email: hannu.heikkila@sata.fi
-
Contact:
- Psychotherapist, MSc in Health Sciences
- Phone Number: +358405696216
- Email: suvi.rantakomi-stansfield@sata.fi
-
Principal Investigator:
- Chief Medical Officer and Physician
-
Sub-Investigator:
- Psychotherapist
-
Sub-Investigator:
- Physiotherapist
-
Sub-Investigator:
- PhD(c), Senior Specialist in Multidisciplinary Services
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult women (18 years or older), assigned female at birth and self-identify as women
- Diagnosed with or experience of chronic, widespread (non-cancer) pain lasting at least two years
- Diagnosed with or living with one or more mild mental health disorders (e.g., anxiety, mild depression), without current or past severe psychiatric conditions
- Diagnosed with or experience of nociplastic pain (e.g., fibromyalgia)
- Not currently using medications that may impair cognitive functioning (e.g., benzodiazepines, anticholinergics, opioids, antipsychotics)
- Able to attend approximately 11 in-person visits over a 3-month period
- Willing and able to participate in a structured therapeutic writing intervention
- Purposefully selected to reflect a range of lived experiences relevant to the study's aims
Exclusion Criteria:
- Presence of severe mental health disorders (e.g., schizophrenia, bipolar disorder, severe depression, or other psychotic conditions)
- Use of medications known to impair memory, attention, or decision-making (e.g., benzodiazepines, anticholinergics, opioids, antipsychotics)
- Participation in other concurrent treatments that may influence study outcomes
- Cognitive limitations that would hinder meaningful engagement in the writing intervention
- Individuals not assigned female at birth or who do not identify as women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Therapeutic Writing Intervention in Pain Rehabilitation
Participants in this single-arm study will take part in a structured therapeutic writing intervention as part of a multidisciplinary pain rehabilitation program at the Pain Clinic of Satasairaala Hospital.
The study spans approximately three months and includes around 11 clinic visits.
The intervention is delivered in two phases: first, four consecutive daily writing sessions (20 minutes each), followed by four weekly sessions (30-60 minutes each).
Prior to the intervention, participants are assessed for eligibility by the clinic's multidisciplinary team and interviewed by the principal investigator.
Post-intervention, participants are interviewed twice to explore their health-related experiences with the writing process.
|
The therapeutic writing intervention is designed to support emotional processing and regulation in individuals with chronic pain and comorbid mental health disorders.
It has been developed specifically for use in a clinical rehabilitation setting and is delivered in two phases over a four-week period at the Pain Clinic of Satasairaala Hospital.
Sessions are conducted in person, with clinical staff available to support participants.
The intervention is non-pharmacological, low-risk, and integrated into the broader multidisciplinary care pathway.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health-Related Experiences of Participants
Time Frame: Baseline (prior to intervention), immediately post-intervention (Week 5), and 3 months post-intervention (Week 17)
|
Description: Qualitative themes identified from semi-structured interviews exploring participants' perceived health-related changes following the writing intervention, including emotional processing, emotion regulation, and meaning-making. Unit of Measure: Thematic categories derived from qualitative content analysis. Time Frame: Data will be collected through semi-structured interviews conducted at three time points: prior to the writing intervention (baseline), immediately after the final writing session (Week 5), and three months after the intervention (Week 17). |
Baseline (prior to intervention), immediately post-intervention (Week 5), and 3 months post-intervention (Week 17)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Impact on Emotion Regulation
Time Frame: Baseline (prior to intervention), immediately post-intervention (Week 5), and 3 months post-intervention (Week 17)
|
Participant-reported changes in emotional awareness, expression, and regulation, identified through qualitative analysis of semi-structured interviews conducted immediately post-intervention. Original Unit of Measure: Thematic categories and frequency of emotion regulation-related content identified through qualitative content analysis. Time Frame: Data will be collected through semi-structured interviews conducted at three time points: prior to the writing intervention (baseline), immediately after the final writing session (Week 5), and three months after the intervention (Week 17). |
Baseline (prior to intervention), immediately post-intervention (Week 5), and 3 months post-intervention (Week 17)
|
|
Themes of Meaning-Making and Future Orientation Identified Through Qualitative Interview Analysis
Time Frame: Baseline (prior to intervention), immediately post-intervention (Week 5), and 3 months post-intervention (Week 17)
|
Description: Themes related to personal meaning, future goals, and psychological growth will be assessed through qualitative content analysis of semi-structured interviews conducted at three time points: baseline, immediately post-intervention (Week 5), and 3 months post-intervention (Week 17). Unit of Measure: Thematic categories and depth of meaning-making and future orientation content identified through qualitative content analysis. Time Frame: Baseline (prior to intervention), immediately post-intervention (Week 5), and 3 months post-intervention (Week 17) |
Baseline (prior to intervention), immediately post-intervention (Week 5), and 3 months post-intervention (Week 17)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R25034
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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