Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2026-01-01 @ 11:02 PM
Study NCT ID:
NCT07058532
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-10
First Post:
2025-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Writing for Adults Suffering From Chronic Pain and Comorbid Mental Health Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000080103', 'term': 'Emotional Regulation'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000068356', 'term': 'Self-Control'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2025-06-23', 'studyFirstSubmitQcDate': '2025-06-30', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health-Related Experiences of Participants', 'timeFrame': 'Baseline (prior to intervention), immediately post-intervention (Week 5), and 3 months post-intervention (Week 17)', 'description': "Description:\n\nQualitative themes identified from semi-structured interviews exploring participants' perceived health-related changes following the writing intervention, including emotional processing, emotion regulation, and meaning-making.\n\nUnit of Measure:\n\nThematic categories derived from qualitative content analysis.\n\nTime Frame:\n\nData 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)."}], 'secondaryOutcomes': [{'measure': 'Perceived Impact on Emotion Regulation', 'timeFrame': 'Baseline (prior to intervention), immediately post-intervention (Week 5), and 3 months post-intervention (Week 17)', 'description': 'Participant-reported changes in emotional awareness, expression, and regulation, identified through qualitative analysis of semi-structured interviews conducted immediately post-intervention.\n\nOriginal Unit of Measure: Thematic categories and frequency of emotion regulation-related content identified through qualitative content analysis.\n\nTime 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).'}, {'measure': 'Themes of Meaning-Making and Future Orientation Identified Through Qualitative Interview Analysis', 'timeFrame': 'Baseline (prior to intervention), immediately post-intervention (Week 5), and 3 months post-intervention (Week 17)', 'description': 'Description:\n\nThemes 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).\n\nUnit of Measure:\n\nThematic categories and depth of meaning-making and future orientation content identified through qualitative content analysis.\n\nTime Frame:\n\nBaseline (prior to intervention), immediately post-intervention (Week 5), and 3 months post-intervention (Week 17)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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'], 'conditions': ['Chronic Pain', 'Mental Health Disorder', 'Psychiatric &Amp;Amp;or Mood Disorder', 'Psychiatric Comorbidities', 'Psychiatric Diagnosis', 'Emotional Pain', 'Emotional Distress', 'Emotion Regulation', 'Emotional Processing', 'Meaning of Life', 'Meaning Made', 'Meaning of Life and Life Satisfaction', 'Depressive Disorder', 'Anxiety Disorders', 'Sleep Disorder', 'Comorbid Depression', 'Process, Acceptance']}, 'descriptionModule': {'briefSummary': '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:\n\nCan therapeutic writing help relieve chronic pain and emotional distress?\n\nHow does writing support emotional processing, regulation, and meaning-making during rehabilitation?\n\nParticipants will take part in a two-part writing intervention involving:\n\nGuided writing exercises that focus on emotional processing, emotion regulation, and creating meaning.\n\nIndividual interviews after the writing sessions to explore their experiences.\n\nThe 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.', 'detailedDescription': "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.\n\nThis 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.\n\nThe 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.\n\nData collection spans two sub-studies:\n\nSub-studies 1 and 2 involve qualitative interviews with participants following the intervention, capturing their firsthand experiences and perceived effects.\n\nThe 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Only individuals who self-identify as women and were assigned female at birth are eligible to participate.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult women (18 years or older), assigned female at birth and self-identify as women\n* Diagnosed with or experience of chronic, widespread (non-cancer) pain lasting at least two years\n* Diagnosed with or living with one or more mild mental health disorders (e.g., anxiety, mild depression), without current or past severe psychiatric conditions\n* Diagnosed with or experience of nociplastic pain (e.g., fibromyalgia)\n* Not currently using medications that may impair cognitive functioning (e.g., benzodiazepines, anticholinergics, opioids, antipsychotics)\n* Able to attend approximately 11 in-person visits over a 3-month period\n* Willing and able to participate in a structured therapeutic writing intervention\n* Purposefully selected to reflect a range of lived experiences relevant to the study's aims\n\nExclusion Criteria:\n\n* Presence of severe mental health disorders (e.g., schizophrenia, bipolar disorder, severe depression, or other psychotic conditions)\n* Use of medications known to impair memory, attention, or decision-making (e.g., benzodiazepines, anticholinergics, opioids, antipsychotics)\n* Participation in other concurrent treatments that may influence study outcomes\n* Cognitive limitations that would hinder meaningful engagement in the writing intervention\n* Individuals not assigned female at birth or who do not identify as women"}, 'identificationModule': {'nctId': 'NCT07058532', 'acronym': 'TWfCP&MH', 'briefTitle': 'Therapeutic Writing for Adults Suffering From Chronic Pain and Comorbid Mental Health Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Tampere University'}, 'officialTitle': 'Therapeutic Writing Intervention in Pain Rehabilitation', 'orgStudyIdInfo': {'id': 'R25034'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Therapeutic Writing Intervention in Pain Rehabilitation', 'description': "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.", 'interventionNames': ['Other: Therapeutic Writing Intervention in Pain Rehabilitation']}], 'interventions': [{'name': 'Therapeutic Writing Intervention in Pain Rehabilitation', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Therapeutic Writing Intervention in Pain Rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28500', 'city': 'Pori', 'state': 'Satakunta', 'country': 'Finland', 'contacts': [{'name': 'Chief Medical Officer and Physician, MD, PhD', 'role': 'CONTACT', 'email': 'hannu.heikkila@sata.fi', 'phone': '+35844707330'}, {'name': 'Psychotherapist, MSc in Health Sciences', 'role': 'CONTACT', 'email': 'suvi.rantakomi-stansfield@sata.fi', 'phone': '+358405696216'}, {'name': 'Chief Medical Officer and Physician', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Psychotherapist', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Physiotherapist', 'role': 'SUB_INVESTIGATOR'}, {'name': 'PhD(c), Senior Specialist in Multidisciplinary Services', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Satasairaala Hospital, Department of Physical Medicine and Rehabilitation: Pain Clinic', 'geoPoint': {'lat': 61.48072, 'lon': 21.78518}}], 'centralContacts': [{'name': 'Toni Salikka, MA, PhD Candidate', 'role': 'CONTACT', 'email': 'toni.salikka@tuni.fi', 'phone': '+358453046569'}, {'name': 'University Lecturer, PhD', 'role': 'CONTACT', 'email': 'sari.frojd@tuni.fi', 'phone': '+358401901623'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Toni Salikka', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MA, PhD Candidate', 'investigatorFullName': 'Toni Salikka', 'investigatorAffiliation': 'Tampere University'}}}}