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NCT Number: NCT04517929

Effectiveness of Group Psychotherapy in Patients With Fibromyalgia Syndrome

The hypothesis of the study is that group therapy in fibromyalgia patients can provide significant improvement in pain, fatigue, anxiety and depression levels and emotional expressions.

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Key information

Conditions

Fibromyalgia Syndrome Anxiety Disorders Behavior Behavioral Symptoms Depression Fibromyalgia Mental Disorders Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University Faculty of Medicine

Izmır, 35100, Turkey (Türkiye)

About this study

The purpose of our study; to determine the effectiveness of group psychotherapy in the treatment of Fibromyalgia Syndrome.

Patients who received 9 weeks of group therapy and those who did not, at the beginning of treatment, at the end of 9 weeks and 6 months after treatment will be evaluated using The Short Form-36, Fibromyalgia Impact Questionnaire, Revised Fibromyalgia Impact Questionnaire, Hospital Anxiety and Depression Scale, Fatigue Severity Scale, Beck Depression Inventory, Beck Anxiety Inventory, Pain Beliefs Scale, Emotional Expression Questionnaire, Visual Analogue Scale, Childhood Trauma Questionnaire, 2016 Fibromyalgia Diagnostic Criteria.

At the end of the study, individuals are expected to show less depressive symptoms and anxiety symptoms compared to the beginning of the study, and it is thought that their complaints about pain will decrease.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fibromyalgia Syndrome diagnosed according to 2016 Fibromyalgia Syndrome diagnostic criteria
  • Volunteers between the ages of 18-65
  • Literate volunteers
  • Volunteering to participate in group work
  • There is no obstacle to attend the sessions regularly every week

Exclusion criteria

  • Who cannot participate in 9-week group therapy
  • Under 18, over 65 years old
  • Confused enough to not be able to complete and understand the scales given cognitively
  • Having serious mental illness (eg Psychotic disorder, Mental Retardation etc.)
  • Illiterate individuals

Treatment and study plan

Group Psychotherapy

Other

9 week group psychotherapy, given by a psychologist trained in group psychotherapy.

Primary outcomes

  1. Change in Pain-Visual Analog Scale

    Time frame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month

    Chronic musculoskeletal pain in Fibromyalgia syndrome patients, in this scale minumum value is 0, maximum value is 10, higher scores means worse outcome.

  2. Change in Depression-Beck Depression Inventory

    Time frame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month

    Depression in Fibromyalgia patients

  3. Change in Anxiety-Beck Anxiety Inventory

    Time frame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month

    Anxiety in Fibromyalgia patients

Secondary outcomes

  1. Change in The Short Form (36) Health Survey

    Time frame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month

    The Short Form (36) Health Survey

  2. Change in Fibromyalgia Impact Questionaire

    Time frame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month

    Fibromyalgia Impact Questionaire

  3. Change in Revised Fibromyalgia Impact Questionnaire

    Time frame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month

    Revised Fibromyalgia Impact Questionnaire

  4. Change in Hospital Anxiety and Depression Scale

    Time frame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month

    Hospital Anxiety and Depression Scale, in this scale minumum value is 0, maximum value is 21, high scores mean worse outcome.

  5. Change in The Fatigue Severity Scale

    Time frame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month

    The Fatigue Severity Scale, In this scale consisting of 9 items, each item is scored between 1 and 7 (1 = strongly disagree, 7 = totally agree) and the total score is calculated by taking the average of 9 items, high scores mean worse outcome.

  6. Change in Pain beliefs questionnaire

    Time frame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month

    Pain beliefs questionnaire

  7. Change in Emotional Expression Questionnaire

    Time frame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month

    Emotional Expression Questionnaire

  8. CHILDHOOD TRAUMA QUESTIONNAIRE

    Time frame: At the beginning of the study

    CHILDHOOD TRAUMA QUESTIONNAIRE

  9. Change in 2016 Fibromyalgia Syndrome Criteria

    Time frame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month

    2016 Fibromyalgia Syndrome Criteria

    2016 Fibromyalgia Diagnostic Criteria

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

Effectiveness of Group Psychotherapy in Patients With Fibromyalgia Syndrome, Randomized Controlled Study

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 19, 2020
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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