Effect of Physiotherapy Protocol in Treatment of Depression: Longitudinal Study

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05786677

Collaborator

(none)

Enrollment

Location

Arms

4.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia Depression	Other: Physiotherapy protocol Drug: Selective serotonin reuptake inhibitors (SSRI)	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Effect of Physiotherapy Protocol in Treatment of Depression: Longitudinal Study

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Jun 15, 2023

Anticipated Study Completion Date :

Aug 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients with fibromyalgia and depression (1) Patients in this group will receive physiotherapy protocol and medications.	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)
Active Comparator: Patients with fibromyalgia and depression (2) Patients in this group will receive medications only.	Drug: Selective serotonin reuptake inhibitors (SSRI) Selective serotonin reuptake inhibitors (SSRIs)
Experimental: Patients with depression only (1) Patients in this group will receive physiotherapy protocol and medications.	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)
Active Comparator: Patients with depression only (2) Patients in this group will receive medications only.	Drug: Selective serotonin reuptake inhibitors (SSRI) Selective serotonin reuptake inhibitors (SSRIs)

Outcome Measures

Primary Outcome Measures

Assessing the change in severity of respondents' 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]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.
Patients diagnosed with mild and moderate forms of major depression.
Their ages range from 20- 60 years old.
Patients willing and able to participate in a physiotherapy program and capable of doing physical exercise on their own.

Exclusion Criteria:

severe spinal injuries
severe musculoskeletal abnormalities
inflammatory rheumatic diseases
respiratory or cardiac pathologies
Any vestibular, visual or neurological dysfunction affecting balance.
History of suicidal attempts
Severe depression
Suffering from severe somatic or psychiatric disorders.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Outpatient clinic faculty of physica therapy cairo university	Dokki		Egypt

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: Mahitab Momen, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mahitab Momen Gamal-Eldien Elansary, Principal Investigator, Cairo University

ClinicalTrials.gov Identifier:

NCT05786677

Other Study ID Numbers:

Mahitab_2023

First Posted:

Mar 27, 2023

Last Update Posted:

Mar 27, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Serotonin Uptake Inhibitors

Study Results

No Results Posted as of Mar 27, 2023