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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616001671459
• Date of registration: 05/12/2016
• Prospective Registration: Yes
• Primary sponsor: University of New South Wales
• Public title: Personalised relaxation practice to improve sleep quality in patients with chronic fatigue syndrome and depression: A Randomised Control Trial
• Scientific title: Personalised relaxation practice to improve sleep and functioning in patients with chronic fatigue syndrome and depression: A Randomised Control Trial
• Date of first enrolment: 16/05/2017
• Target sample size: 128
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12616001671459.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: A/Prof Ute Vollmer-Conna

• Name: A/Prof Ute Vollmer-Conna

Key inclusion & exclusion criteria

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.

Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Chronic Fatigue Syndrome;Depression;
Chronic Fatigue Syndrome
Depression

Mental Health - Depression

Other - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention(s)

Participants randomly allocated to the intervention will be assigned to practise the relaxation method that optimizes de-arousal, determined from the results at the initial autonomic assessment. Laboratory-based autonomic measures include recordings of 3-channel electrocardiogram (ECG), respiration, sweat response and pulsatile skin blood volume. To obtain a baseline recording participants will rest in silence for 10 minutes. This is followed by the presentation of each of the three relaxation methods, order counter balanced across participants. The relaxation method which generates the greatest increase in heart rate variability (HRV), high frequency normalised units (HF nu) relative to resting baseline will be assigned to the participant for nightly practice.

This trial will utilise three different relaxation methods: ‘Guided Relaxation’, ‘Gentle Noise’, and ‘Instrumental Music’, each consisting of pre-recorded 10 minute segments. The Guided Relaxation segments are a calming voice talking through body awareness and/or progressive relaxation.The Gentle noise segments are soft, undulating white noise which sound similar to the ocean or rain. The Instrumental Music segments are calming musical pieces such as Mozart's Flute and Harp Concerto in C, K.299 2nd Movement.

Participants will have free online access to their assigned method and will be able to download the recordings to their smartphone or media device, or if preferred an MP3 player will be provided. Each participant will be provided with seven variations of their assigned method to maximise enjoyment and prevent negative effects of frequent repetition. Participants will be instructed to practice their assigned method at a minimum before bedtime every evening for 4 weeks, and may use at other time

Primary Outcome(s)

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]

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]

Secondary Outcome(s)

Change in daytime functioning as assessed by the Medical Outcomes Survey Short Form (MOS SF-36)[8 weeks after randomisation]

Change in nocturnal autonomic functioning as monitored via nocturnal electrocardiogram (ECG).[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.
[8 weeks after randomisation]

Change in self-reported psychological distress as assessed by the K-10[4 and 8 weeks after randomisation]

Change in self-reported sleep quality as assessed by the PSQI[8 weeks after randomisation]

Intervention Acceptability assessed using a 3-point Likert Scale from 'not at all' to 'completely'.[4 weeks after randomisation]

Self-reported change in stress as assessed by the Perceived Stress Questionnaire (PSQ)[4 and 8 weeks after randomisation]

Secondary ID(s)

nil

Source(s) of Monetary Support

The Judith Jane Mason & Harold Stannett Williams Memorial Foundation

Ethics review

Status: Approved
Approval date:
Contact:

UNSW Human Research Ethics Committee