The Effect of Digital Cognitive Behavioural Therapy for Insomnia on Physical Activity in Fibromyalgia

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for adults with fibromyalgia or chronic widespread pain who also have trouble sleeping. It tests a digital sleep therapy program called Sleepio against standard care with sleep advice materials.

Életkor

18 years or older

Nem

Male or female

A betegség stádiuma

A doctor's diagnosis of fibromyalgia or chronic widespread pain. You must also have insomnia, wake often at night, or wake too early in the morning. You must also report problems with concentration or memory.

Korábbi kezelés

You cannot join if you took prescribed sleep medicines on more than 2 nights in the past 2 weeks. You cannot join if you are now getting another talking therapy for insomnia.

A részvétel fő kizáró okai

• Poor understanding of English, or no reliable internet access
• Nerve or brain conditions that could affect pain tests, epilepsy, dementia or memory decline, or bipolar disorder, schizophrenia or psychosis
• Diagnosed sleep disorders such as sleep apnea, restless leg syndrome, body clock disorder or parasomnia
• Surgery in the past 3 months or planned during the study, or current or planned night shift work
• Pregnant or breastfeeding

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

The goal of this clinical trial is to learn if a digital sleep therapy program (digital Cognitive Behavioural Therapy for Insomnia or dCBT-I) works to improve quality of life and movement in adults with fibromyalgia who also have trouble sleeping. The main questions it aims to answer are:

A vizsgálat 2 csoportja

• Digital Cognitive Behavioural Therapy for InsomniaA vizsgált kezelés

  Participants in this arm will receive access to Sleepio, a digital cognitive behavioural therapy for insomnia (dCBT-I) program. The intervention consists of 6 automated sessions (approximately 20 minutes each) delivered over 10 weeks via web browser or smartphone app. Sessions include evidence-based cognitive and behavioral interventions, sleep hygiene education, time-in-bed restriction, and relaxation exercises. Participants have access to a daily online sleep diary, an online community, and library of resources. SMS reminders will be sent to encourage compliance, and participants will receive telephone or video check-ins from a study investigator at weeks 1, 3, and 6. Participants will also be provided with written sleep hygiene materials from Versus Arthritis, and continue to receive their standard NHS care

  Kezelés: Digital Cognitive Behavioural Therapy for Insomnia és Sleep Hygiene Education Materials

• Standard Care with Sleep Hygiene EducationMár használt kezelés, összehasonlításként

  Participants in this arm will be provided with written sleep hygiene materials from Versus Arthritis, and continue to receive their standard NHS care. Materials include information booklets and video resources on managing fibromyalgia and improving sleep. Participants do not receive access to the Sleepio digital CBT-I program but continue with routine clinical care during the study period.

  Kezelés: Sleep Hygiene Education Materials