Effectiveness of Acceptance and Commitment Therapy on death and health anxiety, cognitive and somatic symptoms of anxiety, and component of acceptance and commitment in patients with multiple sclerosis
The aim of current study is examination the impact of Acceptance and Commitment Therapy on death anxiety, health anxiety, symptoms of anxiety and component of acceptance and commitment in patients with multiple sclerosis. Inclusion criteria (being female, diagnosis of MS by a neurologist) and exclusion criteria (get interventions psychological treatment in the past year and the time of study; history of alcohol abuse or drugs; two sessions of absence for each patient) employed for sampling. Statistical population was all female with primary diagnosis of multiple sclerosis in Tehran, Iran. 48 patients with primary diagnosis of multiple sclerosis disorder were selected. Primary evaluation was carried out with Kurtzke Expanded Disability Status Scale (EDSS), and Structured Clinical Interview for DSM-IV (SCID-I). Working Alliance Inventory-Short Revised (WAI-SR) was carried out in experimental group after intervention. The study design was randomized controlled clinical trials or pre-test and post-test with the control group. Participants were randomly assigned to the intervention group (that receive acceptance and commitment therapy); n=24 and control group (Received routine medical treatment.), n=24. We expect this study show reduction of death anxiety, health anxiety and symptoms of anxiety as well as increasing components of acceptance and commitment therapy in patients with multiple sclerosis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017040833079N2
Registration date:2017-05-02, 1396/02/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-02, 1396/02/12
Registrant information
Name
Morad Rasouli-Azad
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 989355392455
Email address
rasouliazad-m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2017-02-01, 1395/11/13
Expected recruitment end date
2017-07-30, 1396/05/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Acceptance and Commitment Therapy on death and health anxiety, cognitive and somatic symptoms of anxiety, and component of acceptance and commitment in patients with multiple sclerosis
Public title
Effectiveness of Acceptance and Commitment Therapy on death and health anxiety, cognitive and somatic symptoms of anxiety, and component of acceptance and commitment in patients with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: being female; diagnosis of MS by a neurologist; satisfaction and commitment to participate in the study. Exclusion criteria: get interventions psychological treatment in the past year and the time of study; current mania or psychotic episode history of alcohol abuse or drugs; two sessions of absence for each patient.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
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
Research and Technology Management
Street address
Ravand highway، Kashan University of Medical Sciences
City
kashan
Postal code
Approval date
2017-01-18, 1395/10/29
Ethics committee reference number
IR.KAUMS.REC.1395.119
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
somatic Symptoms of anxiety
Timepoint
Before intervention (baseline), after two month (post)
Method of measurement
beck anxiety inventory (BAI)
2
Description
Death anxiety
Timepoint
Before intervention (baseline), after two month (post)
Method of measurement
Death Anxiety Inventory
3
Description
health anxiety
Timepoint
Before intervention (baseline), after two month (post)
Method of measurement
Health Anxiety Inventory
4
Description
cognitive Symptoms of anxiety
Timepoint
Before intervention (baseline), after two month (post)
Method of measurement
Penn State Worry Questionnaire (PSWQ)
5
Description
cognitive fusion
Timepoint
Before intervention (baseline), after two month (post)
Method of measurement
cognitive fusion questionaire (CFQ)
6
Description
components of acceptance and commitment
Timepoint
Before intervention (baseline), after two month (post)
Method of measurement
Acceptance and Action Questionnaire (AAQ-II)
Secondary outcomes
1
Description
therapeutic alliance
Timepoint
after intervention on experimental group
Method of measurement
Working Alliance Inventory-Short Revised (WAI-SR)
2
Description
MS symptoms
Timepoint
Before intervention (baseline)
Method of measurement
Multiple Sclerosis Impact Scale (MSIS-29)
Intervention groups
1
Description
Intervention group: acceptance and commitment group therapy + routine medical treatment
Category
Behavior
2
Description
Control group: Routine medical treatment
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Street address
Hasan Abad Sq., Imam Khomeini St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Science
Full name of responsible person
Gholamali Hamidi
Street address
Ravand 5 km road, Kashan Medical Science Collection
City
Kashan
Grant name
95115
Grant code / Reference number
95115
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
MS Research Center, Neuroscience Institute, Tehran University of Medical Sciences