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Clinical Trials/NCT05786677
NCT05786677
Not yet recruiting
Not Applicable

Effect of Physiotherapy Protocol in Treatment of Depression: Longitudinal Study

Cairo University1 site in 1 country76 target enrollmentApril 1, 2023

Overview

Phase
Not Applicable
Intervention
Physiotherapy protocol
Conditions
Fibromyalgia
Sponsor
Cairo University
Enrollment
76
Locations
1
Primary Endpoint
Assessing the change in severity of respondents' depression
Status
Not yet recruiting
Last Updated
3 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2023
End Date
August 15, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mahitab Momen Gamal-Eldien Elansary

Principal Investigator

Cairo University

Eligibility Criteria

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.

Arms & Interventions

Patients with fibromyalgia and depression (1)

Patients in this group will receive physiotherapy protocol and medications.

Intervention: Physiotherapy protocol

Patients with fibromyalgia and depression (1)

Patients in this group will receive physiotherapy protocol and medications.

Intervention: Selective serotonin reuptake inhibitors (SSRI)

Patients with fibromyalgia and depression (2)

Patients in this group will receive medications only.

Intervention: Selective serotonin reuptake inhibitors (SSRI)

Patients with depression only (1)

Patients in this group will receive physiotherapy protocol and medications.

Intervention: Physiotherapy protocol

Patients with depression only (1)

Patients in this group will receive physiotherapy protocol and medications.

Intervention: Selective serotonin reuptake inhibitors (SSRI)

Patients with depression only (2)

Patients in this group will receive medications only.

Intervention: Selective serotonin reuptake inhibitors (SSRI)

Outcomes

Primary Outcomes

Assessing the change in severity of respondents' depression

Time Frame: 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.

Study Sites (1)

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