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An Ecological Momentary Intervention for Mental Health in Individuals With Ankylosing Spondylitis

14 czerwca 2026 zaktualizowane przez: The Hong Kong Polytechnic University

An Ecological Momentary Intervention for Mental Health in Individuals With Ankylosing Spondylitis: Development, Feasibility Testing, and Preliminary Outcomes Evaluation

Ankylosing spondylitis is a chronic inflammatory rheumatic disease associated with pain, stiffness, reduced mobility, and impaired quality of life. In addition to physical symptoms, individuals with ankylosing spondylitis frequently experience depression, anxiety, stress, and sleep problems. However, existing mental health support is limited and often relies on static assessments and scheduled interventions, which may not respond to patients' fluctuating daily symptoms.

This study aims to develop and pilot test a WeChat-based ecological momentary intervention to improve mental health in individuals with ankylosing spondylitis in China. The study is a prospective, parallel-group, assessor-blinded pilot randomized controlled trial. A total of 36 adults with ankylosing spondylitis and mild-to-moderate depression and/or anxiety will be randomized 1:1 to either an intervention group or a control group.

The intervention group will first receive six brief video-based sessions on cognitive behavioral therapy-related skills during week 1. During weeks 2 to 5, participants will use a WeChat mini-program to complete daily ecological momentary assessments of pain, depression, and anxiety. Symptom-triggered intervention modules will then provide brief, tailored strategies such as cognitive restructuring, behavioral activation, relaxation exercises, self-compassion practice, and SMART goal setting. The control group will receive standard counseling and educational materials.

The primary purpose of this pilot study is to assess feasibility and acceptability, including recruitment, adherence, attrition, engagement, usability, satisfaction, and adverse events. Preliminary effects on depression, anxiety, stress, pain, insomnia, illness perceptions, coping strategies, and quality of life will also be explored at baseline, post-intervention, and 4-week follow-up.

Przegląd badań

Status

Aktywny, nie rekrutujący

Warunki

Interwencja / Leczenie

Szczegółowy opis

Ankylosing spondylitis is a chronic inflammatory disease that mainly affects the spine and sacroiliac joints and may result in persistent pain, stiffness, limited mobility, and functional impairment. Individuals with ankylosing spondylitis are also at increased risk of mental health problems, especially depression and anxiety. These psychological difficulties often fluctuate with pain, disease activity, and daily stress, but few interventions have been specifically designed to address these changing needs in real time.

Ecological momentary intervention is a mobile health approach that delivers timely, personalized support in daily life based on real-time symptom reports. Although ecological momentary intervention has shown benefits in mental health and some rheumatic conditions, it has not yet been specifically developed for individuals with ankylosing spondylitis.

This study aims to assess the feasibility, acceptability, and preliminary efficacy of a WeChat-based ecological momentary intervention for individuals with ankylosing spondylitis in China. The study is designed as a prospective, parallel-group, assessor-blinded pilot randomized controlled trial with a 1:1 allocation ratio. Thirty-six eligible adults with ankylosing spondylitis and mild-to-moderate depression and/or anxiety will be recruited from the rheumatology outpatient department of the First Affiliated Hospital of Guangzhou University of Chinese Medicine.

Participants in the intervention group will receive six daily video-based cognitive behavioral therapy-related sessions in week 1, followed by 4 weeks of ecological momentary intervention delivered through the "Spinal Heart Journey" WeChat mini-program. During the ecological momentary intervention phase, participants will complete one brief daily ecological momentary assessment assessing pain, depressive mood, and anxiety. If symptom scores reach a predefined threshold, the corresponding brief intervention module will be activated. Modules include strategies such as thought recording, cognitive restructuring, behavioral activation, relaxation training, self-compassion exercises, and SMART goal setting. Participants in the control group will receive standard counseling and disease-related educational brochures.

The primary focus of this pilot trial is feasibility and acceptability, including recruitment, adherence, attrition, utilization, engagement, usability, satisfaction, and adverse events. Preliminary outcomes include depression, anxiety, stress, pain, insomnia, illness perceptions, coping strategies, and quality of life. Outcomes will be assessed at baseline, immediately post-intervention, and 4 weeks after the intervention. In addition, post-intervention qualitative interviews will be conducted with selected participants to explore user experiences and inform refinement of the intervention.

This study will provide initial evidence on whether a tailored ecological momentary intervention is feasible, acceptable, and potentially beneficial for improving mental health in individuals with ankylosing spondylitis and will inform the design of a future larger trial.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

36

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Chiny
      • Guangzhou, Chiny
        • The Rheumatology outpatient department at the First Affiliated Hospital of Guangzhou University of Chinese Medicine
  • Hongkong
      • Hong Kong, Hongkong
        • School of Nursing, The Hong Kong Polytechnic University

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

- (1) Clinical diagnosis of ankylosing spondylitis; (2) aged 18 years or above; (3) exhibiting mild to moderate levels of depression (scoring between 10 and 20 on the depression subscale of the Depression Anxiety Stress Scale-21 items) or anxiety (scoring between 8 and 14 on the anxiety subscale of the Depression Anxiety Stress Scale-21 items) [51]; (4) maintained stable drug treatment in the 3 months before recruitment; (5) able to perform basic daily activities (such as walking, sitting, etc.); (6) able to use a smartphone to engage in the ecological momentary intervention; (7) proficient in Cantonese and/or Mandarin Chinese and have the necessary comprehension abilities to understand and be willing to give informed consent.

Exclusion Criteria:

  • (1) have a diagnosed mental illness or a history of mental illness; (2) have other severe chronic diseases (e.g., cardiovascular disease, cancer) that may affect study outcomes or intervention effects; (3) are currently participating in other psychosocial interventions.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Inny
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Grupa kontrolna
Grupa kontrolująca uwagę
Inny: Control group
Participants in the control group will receive standard counseling and educational brochures about the disease. They will be asked to read the educational materials at their own pace during the first 5 weeks, with no additional structured assessments and intervention modules required.
Eksperymentalny: The ecological momentary intervention
The ecological momentary intervention delivered through the "Spinal Heart Journey" WeChat mini-program.
Inny: Intervention Group
Participants allocated to the intervention group will complete six daily 20-minute video-based CBT sessions over the first week, with a Q&A session held on the final day of this week. From Week 2 to Week 5, they will complete daily ecological momentary assessments (3 items, <1 minute per assessment) at random time points between 9:00 AM and 9:00 PM. When scores for pain, anxiety, or depression exceed preset thresholds, tailored intervention modules will be activated, each requiring 10-15 minutes to complete.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Recruitment rate
Ramy czasowe: Baseline
The recruitment rate will be calculated as the percentage of eligible participants who enroll in the study out of the total number of eligible participants
Baseline
Retention rate
Ramy czasowe: Immediately after intervention and at 4 weeks' follow-up
The retention rate will be calculated as the percentage of participants who completed the entire research process (including the follow-up) out of the initial recruitment
Immediately after intervention and at 4 weeks' follow-up
Dropout rate
Ramy czasowe: Immediately after intervention and at 4 weeks' follow-up
The dropout rate will be calculated as the percentage of participants who voluntarily withdrew from the study out of the initial recruitment number
Immediately after intervention and at 4 weeks' follow-up
Usability
Ramy czasowe: Immediately after intervention
The usability of the intervention will be evaluated using the System Usability Scale, a tool capable of assessing the usability of diverse technology-based applications. This scale comprises 10 questions rated on a five-point Likert scale ranging from "Strongly Disagree" to "Strongly Agree."
Immediately after intervention
Adherence rate
Ramy czasowe: From baseline to immediately after intervention
Adherence rate will be measured using two indicators. First, for each momentary assessment, we will determine whether it has been answered (1 for answered, 0 for not answered). Second, adherence to the intervention will be assessed using the number of completed ecological momentary intervention interactive techniques.
From baseline to immediately after intervention
User experience
Ramy czasowe: Immediately after intervention and at 4 weeks' follow-up
To assess program satisfaction, the Acceptability of the Intervention measure will be utilized. This four-item instrument utilizes a 5-point Likert scale (1=completely disagree; 5=completely agree). Higher scores indicate a greater acceptability of the intervention. Subsequently, ten participants will be selected for individual semi-structured interviews to gather insights regarding their experiences and perceptions of the ecological momentary intervention, the challenges encountered during the four weeks, and suggested improvements.
Immediately after intervention and at 4 weeks' follow-up

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Depression and anxiety
Ramy czasowe: Baseline, immediately after intervention and at 4-weeks' follow-up
The depression and anxiety subscales of the Depression Anxiety Stress Scale-21 items will be employed to assess participants' levels of depression and anxiety. Each subscale comprises 7 items and evaluates negative emotional experiences and corresponding physiological responses over the past week. Higher scores indicate greater severity of negative affectivity, with responses rated on a 4-point Likert scale.
Baseline, immediately after intervention and at 4-weeks' follow-up
Stress
Ramy czasowe: Baseline, immediately after intervention and at 4-weeks' follow-up
The stress subscale of the Depression Anxiety Stress Scale-21 items will be utilized to measure stress as a distinct construct. This subscale also consists of 7 items, which assess negative emotional experiences related to stressors encountered in the previous week. Similar to the depression and anxiety subscales, higher scores on the stress subscale reflect greater levels of stress experienced by participants.
Baseline, immediately after intervention and at 4-weeks' follow-up
Pain level
Ramy czasowe: Baseline, immediately after intervention and at 4-weeks' follow-up
The Visual Analogue Scale, a unidimensional tool for measuring pain intensity, will be utilized to assess patients' levels of pain. It has been widely applied across various adult populations for pain intensity evaluation. The scale consists of a 10-centimeter line on which patients mark their perceived pain intensity, with "no pain" at one end and "imagined worst pain" at the other. The distance from the "no pain" point to the participant's mark is then measured to determine the final score, which ranges from 0 to 10, with higher scores indicating greater pain intensity.
Baseline, immediately after intervention and at 4-weeks' follow-up
Insomnia
Ramy czasowe: Baseline, immediately after intervention and at 4-weeks' follow-up
The Insomnia Severity Index, a patient-reported 7-item questionnaire, will be used to assess insomnia symptoms and their impact on daytime functioning. Each item is rated on a scale from 0 to 4, where 0 indicates no problem and 4 indicates a very severe problem, resulting in a total score that ranges from 0 to 28. Scores can be interpreted as follows: absence of insomnia (0-7), subthreshold insomnia (8-14), moderate insomnia (15-21), and severe insomnia (22-28).
Baseline, immediately after intervention and at 4-weeks' follow-up
Illness perception
Ramy czasowe: Baseline, immediately after intervention and at 4-weeks' follow-up
The Brief Illness Perception Questionnaire will be utilized to assess cognitive and emotional representations of illness. The scale consists of eight items graded on a linear 0-10 response scale, with higher scores indicating a more threatening perception of the illness. Each item assesses a specific dimension of illness perception, including consequences, timeline, personal control, treatment control, illness identity, concern, coherence, and emotional representation. The ninth item, which is causal and involves an open-ended response, will be excluded from the analysis.
Baseline, immediately after intervention and at 4-weeks' follow-up
Coping strategies
Ramy czasowe: Baseline, immediately after intervention and at 4-weeks' follow-up
The Trait Coping Style Questionnaire will be employed to assess participants' coping strategies. This 20-item questionnaire includes two dimensions, positive and negative coping, scored on a five-point Likert scale. Higher scores in each dimension (ranging from 10 to 50) reflect a greater tendency to employ that specific coping style. The scale has demonstrated adequate reliability and validity.
Baseline, immediately after intervention and at 4-weeks' follow-up
General quality of life
Ramy czasowe: Baseline, immediately after intervention and at 4-weeks' follow-up
The Short-Form 12-Item Version 2 will be employed to assess eight distinct health domains, evaluating both physical and mental health. Physical health-related domains include general health, physical functioning, role physical, and body pain. The mental health-related scales encompass vitality, social functioning, role, emotional health, and mental health. Scores on the Short-Form 12 Item Version 2 range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Baseline, immediately after intervention and at 4-weeks' follow-up

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

The Hong Kong Polytechnic University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 kwietnia 2026

Zakończenie podstawowe (Szacowany)

31 marca 2027

Ukończenie studiów (Szacowany)

31 marca 2027

Daty rejestracji na studia

Pierwszy przesłany

10 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

10 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

15 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

16 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

14 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • HSEARS20260310001

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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