NCT07058532

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for not_applicable chronic-pain

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 10, 2025

Completed
22 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

July 10, 2025

Status Verified

June 1, 2025

Enrollment Period

8 months

First QC Date

June 23, 2025

Last Update Submit

June 30, 2025

Conditions

Keywords

Therapeutic writingChronic painMental health disordersPsychiatric disordersEmotion regulationEmotional processingMeaning-makingNon-pharmacological interventionLogotherapyPhenomenological analysisPsychosocial rehabilitationPain managementPain copingCreative writing

Outcome Measures

Primary Outcomes (1)

  • Health-Related Experiences of Participants

    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 Outcomes (2)

  • Perceived Impact on Emotion Regulation

    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

    Baseline (prior to intervention), immediately post-intervention (Week 5), and 3 months post-intervention (Week 17)

Study Arms (1)

Therapeutic Writing Intervention in Pain Rehabilitation

EXPERIMENTAL

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

Interventions

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.

Therapeutic Writing Intervention in Pain Rehabilitation

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly individuals who self-identify as women and were assigned female at birth are eligible to participate.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Satasairaala Hospital, Department of Physical Medicine and Rehabilitation: Pain Clinic

Pori, Satakunta, 28500, Finland

Location

MeSH Terms

Conditions

Chronic PainMental DisordersEmotional RegulationPersonal SatisfactionDepressive DisorderAnxiety DisordersSleep Wake DisordersBehaviorAgnosia

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSelf-ControlSocial BehaviorMood DisordersNervous System DiseasesPerceptual DisordersNeurobehavioral Manifestations

Central Study Contacts

Toni Salikka, MA, PhD Candidate

CONTACT

University Lecturer, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MA, PhD Candidate

Study Record Dates

First Submitted

June 23, 2025

First Posted

July 10, 2025

Study Start

August 1, 2025

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

July 10, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

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.

Locations