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

14 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

36

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Gruppo di controllo
Gruppo di controllo dell'attenzione
Altro: 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.
Sperimentale: The ecological momentary intervention
The ecological momentary intervention delivered through the "Spinal Heart Journey" WeChat mini-program.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Recruitment rate
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Depression and anxiety
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

The Hong Kong Polytechnic University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 aprile 2026

Completamento primario (Stimato)

31 marzo 2027

Completamento dello studio (Stimato)

31 marzo 2027

Date di iscrizione allo studio

Primo inviato

10 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

10 giugno 2026

Primo Inserito (Effettivo)

15 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • HSEARS20260310001

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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