Effectiveness of mindfulness-based cognitive therapy separately and combined with TDCS on Worry, Emotion regulation, Pain severity and quality of life in Fibromyalgia patients
Effectiveness of mindfulness-based cognitive therapy separately and combined with transcranial Direct Current Stimulation (TDCS) on Worry, Emotion regulation, Pain severity and quality of life in Fibromyalgia patients
Design
Randomised - consists of control group- three experimental group- each group consists of 12 people.
Settings and conduct
The research has been done on patients referred to rouyan clinic in Tehran. Fibromyalgia patients divided into three experimental and one control group and gone under treatment.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Fibromyalgia disorder. Pain period: at least 6 months. Pain is not related to another disease such as cancer or MS. Ability to attend treatment sessions and not attended in any psychological treatment program during last 6 months.
Exclusion criteria:
suffering from a Rheumatologic or acute psychological disorder which lead to pain. have past epilepsy, seizure disease, Traumatic Brain Injury, brain tumor and brain implant and Mental retardation. acute heart patients using drug pump. Pregnant people. Substance abuse and addicted patients.
Intervention groups
Mindfulness Based Cognitive Therapy Group - tDCS Group - Combination (MBCT and tDCS) Group - Control Group
Main outcome variables
Worry؛ Emotion regulation؛ Pain severity؛ quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201004048920N1
Registration date:2020-11-18, 1399/08/28
Registration timing:registered_while_recruiting
Last update:2020-11-18, 1399/08/28
Update count:0
Registration date
2020-11-18, 1399/08/28
Registrant information
Name
Maryam Akbarzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8873 7529
Email address
m_akbarzadeh@semnan.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-11, 1399/07/20
Expected recruitment end date
2021-01-09, 1399/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of mindfulness-based cognitive therapy separately and combined with TDCS on Worry, Emotion regulation, Pain severity and quality of life in Fibromyalgia patients
Public title
Effectiveness of mindfulness-based cognitive therapy separately and combined with TDCS (device treatment) on Worry, Emotion regulation, Pain severity and quality of life in Chronic muscle pain patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Fibromyalgia disorder.
Pain period: at least 6 months.
Pain is not related to another disease such as cancer or MS.
Ability to attend treatment sessions and not attended in any psychological treatment program during last 6 months
Exclusion criteria:
suffering from a Rheumatologic or acute psychological disorder which lead to pain.
have past epilepsy, seizure disease, Traumatic Brain Injury, brain tumor and brain implant and Mental retardation.
Acute heart patients using drug pump.
Pregnant people.
Substance abuse and addicted patients.
Age
From 30 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization will be used. unit of randomization: individual. randomization tool: random number table. A random number table is a series of digits (0 to 9) arranged randomly in rows and columns. The table usually contains 5-digit numbers, arranged in rows and columns, for ease of reading. Typically, a full table may extend over as many as four or more pages. we have a population of 48 patients and each patient has been assigned a number from 1 to 48. we wish to sample 12 patients to out for each group. Since 48 is a two-digit number, we need to use the first two digits of the numbers listed on the random table. We close our eyes and randomly point to a spot on the table. For this example, we will assume that we selected 50631 in the first column. We interpret that number as 50 (first two digits). Since we don’t have a member of our population with that number, we go down to the next number 29 (29990). We choose this number as 1st sample for first group. Continuing down the chart to select other 11 subjects for the first group. After completing the first group, start this procedure to select next 12 samples for the next group and in this way, we select members of all four sample groups. (during this process, we will ignore duplicate numbers)
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Darband Blvd., Mahdishahr.
City
Semnan
Province
Semnan
Postal code
9591900000
Approval date
2020-09-22, 1399/07/01
Ethics committee reference number
IR.SEMUMS.REC.1399.195
Health conditions studied
1
Description of health condition studied
Fibromyalgia
ICD-10 code
M79.7
ICD-10 code description
Fibromyalgia
Primary outcomes
1
Description
Worry
Timepoint
Before treatment, Maximum a week after treatment, two months after treatment
Method of measurement
Pennsylvania State Worry Questionnaire
2
Description
Emotion regulation
Timepoint
Before treatment, Maximum a week after treatment, two months after treatment
Method of measurement
Cognitive Emotion Regulation Questionnaire
3
Description
Pain severity
Timepoint
Before treatment, Maximum a week after treatment, two months after treatment
Method of measurement
Short-form McGill Pain Questionnaire
4
Description
Quality of life
Timepoint
Before treatment, Maximum a week after treatment, two months after treatment
Method of measurement
Short-Form 36 (SF-36) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Mindfulness-Based Cognitive Therapy (MBCT): Accomplished in groups of 12 people in 2 hours sessions per week. (2 sessions per week) during 1 month on 12 patients. Training includes both formal exercises (e.g. body checkout, sitting meditation, walking meditation and yoga) and informal exercises (such as bringing present awareness to daily activities), Cognitive - behavioral technics such as education, activity supervision and planning, negative spontaneous thoughts recognition and planning response prevention program.
Category
Treatment - Other
2
Description
Intervention group: 8 Sessions tDCS treatment (3 sessions per week). 20 minutes each session. During treatment sessions, cathode electrode will be placed at FP2 area and anode electrode at F3 area. 2mA current will be used.
Category
Treatment - Devices
3
Description
Intervention group: Combination group (MBCT and tDCS)
Category
Treatment - Other
4
Description
Control group: Receive artificial stimulation: Electrode will be placed on patient's head. but as soon as sense of irritation, the device will be turned off and he/she will not receive any stimulation.