Integrative Yoga Therapy for Patients With Chronic Pain and Psychological Distress

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Pain; Psychological Distress
• Intervention / Treatment: Other: Integrative Yoga Therapy

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Leicestershire
    • Leicester, Leicestershire, United Kingdom
      • Karyalaya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Integrative Yoga Therapy; Integrative Yoga Therapy will be provided by yoga therapist once a week and participants will be encouraged to practice at home once or twice a day.	Other: Integrative Yoga Therapy; Yoga therapy will be based on personalised care consisting of Yoga relaxing posture, strengthening exercise, Yoga breathing, meditative psychotherapy, sound and imagery yoga practices, relaxation, yoga diet and life style management.
No Intervention: Wait-list Control; Participants in waiting list will serve as control group for the intervention period. After the ftherapy group has received treatment, the same program will be offered to participants in the wait-list control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Severity: Visual Analogue Scale	Visual Analogue Scale ranging between 0-10 where 0 is no pain at all and 10 is worst pain	From baseline to 8-week post intervention
Pain Disability	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	From baseline to 8-week post intervention
Symptoms of depression and anxiety	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	From baseline to 8-week post intervention

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Aarogyam UK

Study record dates

Study Major Dates

• Study Start (Anticipated): June 15, 2020
• Primary Completion (Anticipated): November 15, 2020
• Study Completion (Anticipated): December 15, 2020

Study Registration Dates

• First Submitted: March 18, 2020
• First Submitted That Met QC Criteria: March 19, 2020
• First Posted (Actual): March 20, 2020

Study Record Updates

• Last Update Posted (Actual): March 20, 2020
• Last Update Submitted That Met QC Criteria: March 19, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: AU07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No