Effect of Physiotherapy Protocol in Treatment of Depression: Longitudinal Study

Not Applicable

Not yet recruiting

• Conditions: Fibromyalgia; Depression
• Interventions: Drug: Selective serotonin reuptake inhibitors (SSRI); Other: Physiotherapy protocol

• Registration Number: NCT05786677
• Lead Sponsor: Cairo University

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.

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-14
• Study First Submitted QC: 2023-03-24
• Last Update Submitted: 2023-03-24
• Study First Posted: 2023-03-27
• Last Update Posted: 2023-03-27
• Study Start: 2023-04-01
• Primary Completion: 2023-06-15
• Study Completion: 2023-08-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 76

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with depression only (2)	Selective serotonin reuptake inhibitors (SSRI)	Patients in this group will receive medications only.
Patients with fibromyalgia and depression (2)	Selective serotonin reuptake inhibitors (SSRI)	Patients in this group will receive medications only.
Patients with fibromyalgia and depression (1)	Physiotherapy protocol	Patients in this group will receive physiotherapy protocol and medications.
Patients with fibromyalgia and depression (1)	Selective serotonin reuptake inhibitors (SSRI)	Patients in this group will receive physiotherapy protocol and medications.
Patients with depression only (1)	Physiotherapy protocol	Patients in this group will receive physiotherapy protocol and medications.
Patients with depression only (1)	Selective serotonin reuptake inhibitors (SSRI)	Patients in this group will receive physiotherapy protocol and medications.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Outpatient clinic faculty of physica therapy cairo university; 🇪🇬 Dokki, Egypt