Personalised relaxation practice to improve sleep quality in patients with chronic fatigue syndrome and depression: A Randomised Control Trial

Not Applicable

Recruiting

• Conditions: Chronic Fatigue Syndrome; Depression; Other - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis); Mental Health - Depression

• Registration Number: ACTRN12616001671459
• Lead Sponsor: niversity of New South Wales

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

Meet international diagnostic criteria for chronic fatigue syndrome; or DSM-V diagnostic criteria for depression; Normal or corrected to normal hearing; Sufficient English to complete the questionnaires and follow the guided relaxation tasks;Willingness and ability to give written informed consent and willingness to participate and comply with the longitudinal nature study.

Exclusion Criteria

Pregnant; Other significant illness or major diagnoses such as primary sleep disorder, heart conditions, uncontrolled diabetes, chronic infections, or psychotic disorders; Taking regular medications that affect autonomic activity including beta-blockers/anti-hypertensives; concurrently engaged in other psycho-behavioural interventions. Use of anti-depressants or the oral-contraceptive pill will be recorded but not exclusionary.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in daytime functioning as assessed by the Medical Outcomes Survey Short Form (MOS SF-36)[4 weeks after randomisation];Change in self-reported sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI); and daily sleep log[4 weeks after randomisation];Change in self-reported physical and psychological health as assessed by the Somatic and Psychological Health Report (SPHERE). This questionnaire contains two validated sub-scales for somatic and psychological symptoms (the SOMA and PSYC) and also provides an overall composite score.[4 weeks after randomisation]

Secondary Outcome Measures

Name	Time	Method
Change in nocturnal autonomic functioning as monitored via nocturnal electrocardiogram (ECG).[4 weeks after randomisation];Change in self-reported sleep quality as assessed by the PSQI[8 weeks after randomisation];Change in self-reported physical and psychological health as assessed by the Somatic and Psychological Health Report (SPHERE). This questionnaire contains two validated sub-scales for somatic and psychological symptoms (the SOMA and PSYC) and also provides an overall composite score.<br>[8 weeks after randomisation];Change in daytime functioning as assessed by the Medical Outcomes Survey Short Form (MOS SF-36)[8 weeks after randomisation];Intervention Acceptability assessed using a 3-point Likert Scale from 'not at all' to 'completely'.[4 weeks after randomisation]; Change in self-reported psychological distress as assessed by the K-10[4 and 8 weeks after randomisation];Self-reported change in stress as assessed by the Perceived Stress Questionnaire (PSQ)[4 and 8 weeks after randomisation]