Evaluating the effectiveness of Intensive Short term Dynamic Psychotherapy on tension headache cases
Design
Clinical trial, with control and experimental groups, parallel, single blind, randomized, on 15 patients. Block randomization method is used for randomization
Settings and conduct
Place of the study: internal neurology clinic of Rasool Akram Hospital, Tehran.
Study population: people suffering from tension headaches referred to the internal neurology clinic of Rasool Akram Hospital in Tehran.
Participants/Inclusion and exclusion criteria
Inclusion criterion: Having a tension headache based on neurologist diagnosis. Non-inclusion criterion: being affected by severe physical illness
Intervention groups
Intervention groups: Intensive Short term Dynamic Psychotherapy based on Jon Fredrickson will be used.
Control groups: They do not receive any intervention.
Main outcome variables
Tension Headache
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221101056370N1
Registration date:2023-07-21, 1402/04/30
Registration timing:retrospective
Last update:2023-07-21, 1402/04/30
Update count:0
Registration date
2023-07-21, 1402/04/30
Registrant information
Name
Zahra Ahmadvand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3334 2535
Email address
ahmadvandz@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-03-03, 1400/12/12
Actual recruitment start date
2021-09-23, 1400/07/01
Actual recruitment end date
2022-04-22, 1401/02/02
Trial completion date
2023-02-01, 1401/11/12
Scientific title
Effectivness of Intensive Short term Dynamic Psychotherapy on tension headache cases.
Public title
Effectivness of Intensive Short term Dynamic Psychotherapy on tension headache.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having tension headache based on the neurologist diagnosis
Having at least an average IQ
at least Diploma education
age between 18-50 year old
Exclusion criteria:
Having a significant physical illness based on the interview
Having a severe psychiatric disorder according to the fifth edition of the Diagnostic and Statistical Manual Illnesses DSM-5
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
15
Actual sample size reached:
15
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the Restricted Randomization method of block randomization will be used. The number of samples assigned to each study groups become equal and in this study, we will have blocks of size 4. Random allocation software is used that this random sequence generation software in addition to simple randomization are able to generate random sequence by blocking method. Allocation concealment is also used, which is the method used to execute a random sequence on study participants. In such a way that the assigned group is not known before the individual is assigned. Using Sequentially numbered, sealed, opaque envelopes, each random sequence created is recorded on a card. And the cards are placed in the envelopes respectively. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes is opened in order and the assigned group of the participant is revealed.
Blinding (investigator's opinion)
Single blinded
Blinding description
Evaluator and statistical analysts are blind to the research process. The statistical analyst is blind to the belonging of the data to the experimental and control group of the research so that the data analysis is done without bias.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences; next to Milad Tower; Hemat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2021-08-24, 1400/06/02
Ethics committee reference number
IR.IUMS.REC.1400.439
Health conditions studied
1
Description of health condition studied
Tension headache
ICD-10 code
G44.2
ICD-10 code description
Tension-type headache
Primary outcomes
1
Description
Headache score in International Classification of Headache Disorders (ICHD-II)
Timepoint
before the intervention, last session, 2months after the intervention
Method of measurement
Second International Classification of Headache Disorders (ICHD-II)
Secondary outcomes
1
Description
The symptom of emotion regulation
Timepoint
before the intervention, last session, 2months after intervention
Method of measurement
Gross and John emotional regulation
2
Description
the symptom of state- trait of Anger
Timepoint
before the intervention, last session, 2months after intervention
Method of measurement
Staxi questionnaire
3
Description
the Symptom of Anxiety
Timepoint
before the intervention, last session, 2months after intervention
Method of measurement
Beck anxiety inventory (BAI)
Intervention groups
1
Description
Intervention group: In this group, short-term psychodynamic therapy based on John Frederickson's model is used. In this protocol, the therapist changes the way of emptying anxiety in the body, improves the patient's capacity to observe emotions, anxiety and defenses internally.In this format, the therapist gradually calls out emotions so that the problems that the patient has with anxiety, backward defenses or self-observation capacity appear. At the same moment, the therapist strengthens the patient's capacity and then, again, gradually calls up the feeling.
Category
Treatment - Other
2
Description
Control group: Participants do not receive any intervention.