Integrative Yoga Therapy for Patients With Chronic Pain and Psychological Distress

Not Applicable

• Conditions: Psychological Distress; Chronic Pain

• Registration Number: NCT04315805
• Lead Sponsor: Aarogyam UK

Brief Summary

This study will be a randomized wait list controlled trial studying the efficacy of an Integrative Yoga Therapy for patients with chronic pain and psychological distress. Individualised yoga program will consist of a 8-week guided self-help program.

This study will primarily investigate whether an individually tailored yoga can be beneficial for patients suffering from chronic pain reducing pain, anxiety depression, while improving overall quality of life.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-18
• Study First Submitted QC: 2020-03-19
• Last Update Submitted: 2020-03-19
• Study First Posted: 2020-03-20
• Last Update Posted: 2020-03-20
• Study Start: 2020-06-15
• Primary Completion: 2020-11-15
• Study Completion: 2020-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Experienced pain for > 3 months
• Experiences at least one type of psychological distress such as: depression, anxiety, insomnia or stress
• Willing to provide informed consent

Exclusion Criteria

• Severe medical or psychiatric conditions
• Alcohol or substance abuse
• Active suicidality
• Terminal illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Symptoms of depression and anxiety	From baseline to 8-week post intervention	Hospital Anxiety Depression Scale with 14 item. Each item on the questionnaire is scored from 0-3 where higher score represents increased anxiety and depression levels
Pain Disability	From baseline to 8-week post intervention	Change in pain disability using Pain Disability Index (PDI) with 7 item.Each item scores on 0-10 numeric rating scale in which 0 means no disability and 10 is maximum disability
Pain Severity: Visual Analogue Scale	From baseline to 8-week post intervention	Visual Analogue Scale ranging between 0-10 where 0 is no pain at all and 10 is worst pain

Secondary Outcome Measures

Name	Time	Method
Self Efficacy: Pain Self-Efficacy Questionnaire (PSEQ)- 2 item scale	From baseline to 8-week post intervention	Pain Self-Efficacy Questionnaire (PSEQ)- 2 item scale
Insomnia symptoms	From baseline to 8-week post intervention	Insomnia Severity Index has seven questions each scores between 0-4. Higher score defines severity of clinical insomnia
Mental well-being	From baseline to 8-week post intervention	The Short Warwick-Edinburgh Mental Wellbeing Scale; Minimum score: 7; maximum score: 35; higher score indicates greater level of wellbeing

Trial Locations

Locations (1)

Karyalaya; 🇬🇧 Leicester, Leicestershire, United Kingdom