Therapeutic Writing for Adults Suffering From Chronic Pain and Comorbid Mental Health Disorders (TWfCP&MH)

August 30, 2026 updated by: Toni Salikka

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Finland
    • Satakunta
      • Pori, Satakunta, Finland, 28500
        • Satasairaala Hospital, Department of Physical Medicine and Rehabilitation: Pain Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Therapeutic Writing Intervention in Pain Rehabilitation
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Toni Salikka

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R25034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared due to privacy and confidentiality concerns. The data includes sensitive personal information that cannot be fully anonymized without risking participant identification.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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