Effectiveness of intensive short-term dynamic psychotherapy on anxiety, depression, pain intensity and sleep disorders
Design
A clinical trial on two women, with single group, non-blinded, non-randomized and accessible was used.
Settings and conduct
The short-term intensive psychodynamic therapy protocol will be conducted in 14 sessions on each of the two participants thorough 60 to 90 minutes sessions per week. The participants are the clients of Vasei Sabzevar Hospital who have referred as self-reported.
Participants/Inclusion and exclusion criteria
Entry requirements include people who are diagnosed with migraine, people between 25-45 years of age, and people with a minimum educational degree of diploma.
The non-entry conditions include people who are determined to be unsuitable for short-term intensive dynamic psychotherapy thorough in the experimental treatment session
Intervention groups
Investigating the effectiveness of short-term intensive psychodynamic therapy on two women with migraine
Main outcome variables
Treatment of anxiety, depression, pain intensity and sleep disorders in people with migraine
General information
Reason for update
Acronym
ISTDP
IRCT registration information
IRCT registration number:IRCT20240528061920N1
Registration date:2024-06-21, 1403/04/01
Registration timing:prospective
Last update:2024-06-21, 1403/04/01
Update count:0
Registration date
2024-06-21, 1403/04/01
Registrant information
Name
Toktam Ameri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4464 2385
Email address
toktam.ameri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-10, 1403/05/20
Expected recruitment end date
2024-09-10, 1403/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of intensive short-term dynamic psychotherapy on anxiety, depression, pain intensity and sleep disorders: a case study
Public title
Effectiveness of intensive short-term dynamic psychotherapy on anxiety, depression, pain intensity and sleep disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People who are diagnosed with migraine
Between 25-45 years old
People who hold at least a diploma degree
Did not use another psychotherapy method(s) already or simultaneously
Exclusion criteria:
People who are not compatible for ISTDP thorough experimental session
Age
From 25 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
2
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Azad University of Neyshabur branch
Street address
No. 29, 7th Faqih, Faqih St., Razi St.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618747714
Approval date
2024-06-11, 1403/03/22
Ethics committee reference number
IR.IAU.NEYSHABUR.REC.1403.019
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Anxiety score in Beck Anxiety questionnaire
Timepoint
Measuring anxiety in three different time periods. First, for three times before the start of the intervention with one week intervals. Second measurement is on the 5th, 10th and 14th session after the start of the intervention, and last one is two weeks and one month after the end of the intervention.
Method of measurement
Beck Anxiety questionnaire
2
Description
Depression score in Beck Depression questionnaire
Timepoint
Measuring depression in three different time periods. First, for three times before the start of the intervention with one week intervals. Second measurement is on the 5th, 10th and 14th session after the start of the intervention, and last one is two weeks and one month after the end of the intervention.
Method of measurement
Beck Depression questionnaire
3
Description
Pain intensity score in McGill Pain Intensity questionnaire
Timepoint
Measuring pain intensity in three different time periods. First, for three times before the start of the intervention with one week intervals. Second measurement is on the 5th, 10th and 14th session after the start of the intervention, and last one is two weeks and one month after the end of the intervention.
Method of measurement
Short -Form Mc Gill Pain Questionnaire
4
Description
Sleep quality score in the Pittsburgh Sleep Quality questionnaire
Timepoint
Measuring sleep quality in three different time periods. First, for three times before the start of the intervention with one week intervals. Second measurement is on the 5th, 10th and 14th session after the start of the intervention, and last one is two weeks and one month after the end of the intervention.
Method of measurement
Pittsburg Sleep Quality questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intensive short-term dynamic psychotherapy in 14 sessions (one session per week)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sabzavar Vasei hospital
Full name of responsible person
Toktam Ameri
Street address
No. 29, 7th Faqih, Faqih St., Razi St.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618747714
Phone
+98 51 4464 2385
Email
toktam.ameri@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Samane Dolatabadi
Street address
No. 29, 7th Faqih, Faqih St., Razi St.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618747714
Phone
+98 51 4464 2385
Email
toktam.ameri@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Toktam Ameri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 29, 7th Faqih, Faqih St., Razi St.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618747714
Phone
+98 51 4464 2385
Email
toktam.ameri@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Toktam Ameri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 29, 7th Faqih, Faqih St., Razi St.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618747714
Phone
+98 51 4464 2385
Email
toktam.ameri@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Toktam Ameri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 29, 7th Faqih, Faqih St., Razi St.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618747714
Phone
+98 51 4464 2385
Email
toktam.ameri@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All the information about the participants and the main result(s) will be published as thesis and article.
When the data will become available and for how long
All data is available 6 months after result(s) published
To whom data/document is available
All researchers and people who work in the field of psychotherapy, university professors or students, and scientific and therapeutic centers.
Under which criteria data/document could be used
In order to treat migraine patients
The applicant must be a psychotherapist
The applicant must work in one of the medical centers
The applicant must be a master or PhD student in clinical psychology
From where data/document is obtainable
Toktam Ameri
toktam.ameri@gmail.com
What processes are involved for a request to access data/document
sending an email by the applicant. documents and data files will be sent to the applicant within two weeks to one month if the required terms are satisfied