Effect of Physiotherapy Protocol in Treatment of Depression: Longitudinal Study

NCT05786677 | Unknown DMC

• 1 other identifier: Mahitab_2023
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia; Depression

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Patients with fibromyalgia and depression (1)

EXPERIMENTAL

Patients in this group will receive physiotherapy protocol and medications.

Other: Physiotherapy protocol; Drug: Selective serotonin reuptake inhibitors (SSRI)

Patients with fibromyalgia and depression (2)

ACTIVE COMPARATOR

Patients in this group will receive medications only.

Drug: Selective serotonin reuptake inhibitors (SSRI)

Patients with depression only (1)

EXPERIMENTAL

Patients in this group will receive physiotherapy protocol and medications.

Other: Physiotherapy protocol; Drug: Selective serotonin reuptake inhibitors (SSRI)

Patients with depression only (2)

ACTIVE COMPARATOR

Patients in this group will receive medications only.

Drug: Selective serotonin reuptake inhibitors (SSRI)

Interventions

Physiotherapy protocol OTHER

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: 1. Suboccipital release 2. Diaphragm release 3. Clavi-pectoral myofascial release 6. Home Routine c. Hot tub bath for 30 minutes d. Breathing exercise

Patients with depression only (1); Patients with fibromyalgia and depression (1)

Selective serotonin reuptake inhibitors (SSRI) DRUG

Selective serotonin reuptake inhibitors (SSRIs)

Patients with depression only (1); Patients with depression only (2); Patients with fibromyalgia and depression (1); Patients with fibromyalgia and depression (2)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Outpatient clinic faculty of physica therapy cairo university

Dokki, Egypt

Location

MeSH Terms

Conditions

Fibromyalgia; Depression

Interventions

Selective Serotonin Reuptake Inhibitors

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs

Study Officials

• Mahitab Momen

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahitab Momen

CONTACT

010226960790; bobapt@hotmail.com

Mahitab Momen

CONTACT

bobapt@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: March 27, 2023
• Study Start: April 1, 2023
• Primary Completion: June 15, 2023
• Study Completion: August 15, 2023
• Last Updated: March 27, 2023

Record last verified: 2023-03

Locations

EG (1)