The effectiveness of attention rehabilitation in anxious patients
Design
The present study is a randomized clinical trial with a semi-experimental design with pre-test and post-test with control group with a one month follow-up plan.
Settings and conduct
The intervention was carried out at Arash Mani psychotherapy clinic, The intervention was performed in the daily hospital. Meetings were held twice a week. Participants were randomly assigned to groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria : 1) having received diagnosis of a anxiety disorder by a psychologist or psychiatrist, 2) average score of 16-25 on Beck Anxiety Test, 3) having at least a diploma qualification or above, 4) over 18 years of age, 5) If one has received psychiatric intervention, at least 4 months must have passed, meaning that the medication has exerted its therapeutic effect and we have controlled its effectiveness. In the pre-test, we are in the maintenance stage of drug treatment. Exclusion criteria : 1) Suffering from an acute psychiatric disorder or other disorders such as schizophrenia spectrum, 2) suffering from severe physical illnesses requiring hospitalization, 3) dependence and addiction to drugs, medicine or alcohol, 4) suffering from mental retardation.
Intervention groups
Intervention group: Receives group therapy sessions (if receiving medication treatment, 4 months have passed since the treatment). The interventions lasted for 3 weeks. The sessions were held twice a week and each session was two hours. Control group: Does not receive individual or group psychotherapy. If receiving medication treatment, 4 months have passed since the medication treatment.
Main outcome variables
The score of anxiety in Beck Anxiety Inventory
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230617058502N1
Registration date:2023-10-07, 1402/07/15
Registration timing:retrospective
Last update:2023-10-07, 1402/07/15
Update count:0
Registration date
2023-10-07, 1402/07/15
Registrant information
Name
Leila Khabir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3641 0041
Email address
leila.khabir@iau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-10, 1402/05/19
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Attention rehabilitation for anxious patients
Public title
Attention rehabilitation for anxious patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
having received diagnosis of anxiety disorders by a psychologist or psychiatrist
average score of 16-25 on Beck Anxiety Inventory
minimum educational qualification is a diploma
over 18 years of age
If one has received psychiatric intervention, at least 4 months must have passed, meaning that the medication has exerted its therapeutic effect and we have controlled its effectiveness. In the pre-test, we are in the maintenance stage of drug treatment.
Exclusion criteria:
Suffering from an acute psychiatric disorder or other disorders such as schizophrenia spectrum
Suffering from severe physical illnesses requiring hospitalization
Dependence and addiction to drugs, medicine or alcohol
Suffering from mental retardation.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
For the random allocation of the participants to the intervention and control groups, which were named A and B respectively, 30 numbers from the random number table were selected by computer. First, numbers 1 to 30 were given to each participant and then using the simple random sampling method, 15 people were randomly selected and placed in the intervention group. The remaining 15 people also entered the control group.
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 Ethics Committees of Islamic Azad University- Shiraz Branch
Street address
South Qa'ani street, 14th Alley, Faculty of Dentistry
City
Shiraz
Province
Fars
Postal code
00000000
Approval date
2023-06-19, 1402/03/29
Ethics committee reference number
IR.IAU.SHIRAZ.REC.1402.067
Health conditions studied
1
Description of health condition studied
Anxiety Disorders
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Anxiety score in Beck Anxiety Inventory
Timepoint
Assessing the anxiety level of the participants before, immediately and one month after the intervention
Method of measurement
Beck Anxiety Inventory
Secondary outcomes
1
Description
Executive functions score in Wisconsin Card Sorting Test
Timepoint
before, immediately and one month after the intervention
Method of measurement
Wisconsin Card Sorting Test (WCST)
2
Description
Memory score in Digit Span
Timepoint
before, immediately and one month after the intervention
Method of measurement
Digit Span (DGS) measure in WISC
3
Description
Attention score in The Stroop Color and Word Test
Timepoint
before, immediately and one month after the intervention
Method of measurement
The Stroop Color and Word Test
Intervention groups
1
Description
Intervention group: Cognitive attention rehabilitation for the intervention group was conducted in six sessions. The first session included pre-test and introduction of attention and levels of attention as input in the information processing model and explained the impairment and involvement of attention in anxious patients. In the second session, intervention training at the first level of attention and selective attention was explained to the patients and exercises were performed in this area. The third session included intervention training at the level of attention maintenance and exercises in this area. The fourth session included intervention training in divided attention and exercises in this area. The fifth session included re-explaining the levels of attention and integrating the techniques and performing the exercise. In the sixth session, exercises were performed in the field of attention and also included completing the post-test. Between sessions, exercises were also given to be done at home, which were checked at the beginning of the next session. At the beginning of all sessions, a form was given to the patient and asked to rate their anxious thoughts and anxiety level from 0 to 100, and at the end of the sessions, patients were asked to rate their anxiety level again from 0 to 100.
Category
Rehabilitation
2
Description
Control group: no psychological intervention: Subjects in this group did not receive psychological interventions individually or in groups.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez hospital
Full name of responsible person
Yalda Nasihatkon
Street address
Hafez hospital., Chamran Blv
City
Shiraz
Province
Fars
Postal code
71946-34786
Phone
+98 71 3647 9531
Email
hafezhospt@sums.ac.ir
2
Recruitment center
Name of recruitment center
Ebnesina hospital
Full name of responsible person
Yalda Nasihatkon
Street address
Ebnesina hospital, Hafez street
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3228 9600
Email
info@ebnesinahospital.com
3
Recruitment center
Name of recruitment center
Dr. Arash Mani psychotherapy clinic
Full name of responsible person
Yalda Nasihatkon
Street address
Farzanegan building, Alley 43, Zand street
City
Shiraz
Province
Fars
Postal code
0000000000
Phone
+98 920 720 4261
Email
mania@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University of Shiraz
Full name of responsible person
Dr. Leila Khabir
Street address
Shiraz, 5th Km Of Sadra
City
Shiraz
Province
Fars
Postal code
5-71993
Phone
+98 936 237 1565
Email
Nasihatkonyalda@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?