Chronic PainTWfCP&MHNCT07058532
Therapeutic Writing for Adults Suffering From Chronic Pain and Comorbid Mental Health Disorders
A study testing Therapeutic Writing Intervention in Pain Rehabilitation in people with Chronic Pain and Mental Health Disorder, run by Toni Salikka at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chronic Pain, Mental Health Disorder, Psychiatric &Amp;Amp;or Mood Disorder
- What is being tested?
- Therapeutic Writing Intervention in Pain Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2025to Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Finland1 site
Satasairaala Hospital, Department of Physical Medicine and Rehabilitation: Pain Clinic
Pori, Satakunta, 28500
About this study
Official title: 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?
Read more
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.
Read the 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.
- Conditions
- Chronic Pain, Mental Health Disorder, Psychiatric &Amp;Amp;or Mood Disorder, Psychiatric Comorbidities, Psychiatric Diagnosis, Emotional Pain
- Being tested
- Therapeutic Writing Intervention in Pain Rehabilitation
- Keywords
- Therapeutic writing, Chronic pain, Mental health disorders, Psychiatric disorders, Emotion regulation, Emotional processing, Meaning-making, Non-pharmacological intervention, Logotherapy, Phenomenological analysis, Psychosocial rehabilitation, Pain management, Pain coping, Creative writing
- Medical subject headings
- Chronic Pain, Mental Disorders, Emotional Regulation, Personal Satisfaction, Depressive Disorder, Anxiety Disorders, Sleep Wake Disorders, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Writing Intervention in Pain RehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Therapeutic Writing Intervention in Pain Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline (prior to intervention), immediately post-intervention (Week 5), and 3 months post-intervention (Week 17)
Secondary outcomes (2)
Perceived Impact on Emotion Regulation
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).
Measured: 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
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)
Measured: Baseline (prior to intervention), immediately post-intervention (Week 5), and 3 months post-intervention (Week 17)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study startSep 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Why it stopped: The collaborator could not proceed with the study due to personnel changes.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toni Salikka
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Toni Salikka, Tampere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058532
- Sponsor's protocol ID
- R25034
- Acronym
- TWfCP&MH
- Status last verified
- Aug 2026
- First submitted
- 23 Jun 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Writing Intervention in Pain Rehabilitation
- ClinicalTrials.gov ID
- NCT07058532
- Acronym / sponsor ID
- TWfCP&MH / R25034
- Conditions
- Chronic Pain, Mental Health Disorder, Psychiatric &Amp;Amp;or Mood Disorder, Psychiatric Comorbidities, Psychiatric Diagnosis, Emotional Pain
- Keywords
- Therapeutic writing, Chronic pain, Mental health disorders, Psychiatric disorders, Emotion regulation, Emotional processing, Meaning-making, Non-pharmacological intervention
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The collaborator could not proceed with the study due to personnel changes.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Toni SalikkaUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 10 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Writing Intervention in Pain Rehabilitation | Experimental | Other: Therapeutic Writing Intervention in Pain RehabilitationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic Writing Intervention in Pain RehabilitationThe 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. | Other | Therapeutic Writing Intervention in Pain Rehabilitation |
Primary outcome
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).
2 secondary outcomes
Perceived Impact on Emotion Regulation
Time frame: 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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Writing Intervention in Pain Rehabilitation in people with Chronic Pain and Mental Health Disorder, run by Toni Salikka at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-Related Experiences of Participants (time frame: Baseline (prior to intervention), immediately post-intervention (Week 5), and 3 months post-intervention (Week 17)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.