Integrative Yoga Therapy for Patients With Chronic Pain and Psychological Distress

Study Overview
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Brief Summary
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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.

Official Title
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Integrative Yoga Therapy for Patients With Chronic Pain and Psychological Distress

Conditions
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Chronic Pain, Psychological Distress

Intervention / Treatment
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* Other: Integrative Yoga Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integrative Yoga Therapy<br>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<br>* 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.<br>|
| No Intervention: Wait-list Control<br>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?
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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 |