Effect of Physiotherapy Protocol in Treatment of Depression: Longitudinal Study

Depression Clinical Trial

Official title:

Effect of Physiotherapy Protocol in Treatment of Depression: Longitudinal Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05786677
• Other study ID #: Mahitab_2023
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: August 15, 2023

Study information

• Verified date: March 2023
• Source: Cairo University
• Contact: Mahitab Momen
• Phone: 010226960790
• Email: bobapt[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of his study is to investigate the effect of physiotherapy protocol in management of depression in patients with fibromyalgia and in patients with psychogenic depression.

Description:

This study will investigate the effect of physiotherapy protocol in management of depression in patients with fibromyalgia and in patients with psychogenic depression.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 76
• Est. completion date: August 15, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Fibromyalgia patients will be included if they meet the diagnosis of FM according to the American College Rheumatology (ACR), diagnosed with depression and referred by a physician.

2. Patients diagnosed with mild and moderate forms of major depression.

3. Their ages range from 20- 60 years old.

4. Patients willing and able to participate in a physiotherapy program and capable of doing physical exercise on their own.

Exclusion Criteria:

1. severe spinal injuries

2. severe musculoskeletal abnormalities

3. inflammatory rheumatic diseases

4. respiratory or cardiac pathologies

5. Any vestibular, visual or neurological dysfunction affecting balance.

6. History of suicidal attempts

7. Severe depression

8. Suffering from severe somatic or psychiatric disorders.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Fibromyalgia

Intervention

Other:
• Physiotherapy protocol
the physiotherapy protocol which will include: 4. Exercise in the form of: d. Breathing exercise e. Aerobic exercise (walking on treadmill with a speed of 3 miles per hour and 0% inclination) f. Bridging exercise 5. Manual techniques in the form of: Suboccipital release Diaphragm release Clavi-pectoral myofascial release 6. Home Routine c. Hot tub bath for 30 minutes d. Breathing exercise

Drug:
• Selective serotonin reuptake inhibitors (SSRI)
Selective serotonin reuptake inhibitors (SSRIs)

Locations

Country	Name	City	State
Egypt	Outpatient clinic faculty of physica therapy cairo university	Dokki

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessing the change in severity of respondents' depression	Assessment will be done by using Arabic version of Beck Depression Inventory (BDI) which is designed to rate the severity of respondents' depression in the weeks preceding questionnaire completion. Each of the 21 questions presents four different statements and asks respondents to select the option that best represents them. Statements refer to depressive states in varying degrees of severity (from "I do not feel sad" to "I am so sad or unhappy that I can't stand it"), and this is reflected in the scoring process which assigns higher values to responses indicating more acute symptoms of depression. The total score can range from 0 to 63 points, with a total score of 0-9 points indicating minimal depression, 10-18 points mild, 19-29 points moderate, and 30-63 points severe depression.	at baseline, after 2 weeks of intervention, after 4 weeks of intervention and after one month and two months of end of treatment period