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The effects of panic-focused psychodynamic psychotherapy on emotional awareness and interpersonal problems in predicting improvements of panic symptoms and related disability

Protocol summary

Study aim
Determining the effectiveness of Panic-Focused Psychodynamic Psychotherapy (PFPP) on the severity of symptoms, disability, emotional awareness and interpersonal problems in patients with Panic disorder.
Design
A clinical trial with a single-case design, multiple baselines (different subjects), no control group, no randomization, no blinding on five patients selected with a purposeful sampling.
Settings and conduct
Panic Focused Psychodynamic Psychotherapy (PFPP) is performed individually and in 24 treatment sessions for patients with panic disorder at Dr. Beheshti Psychiatric Hospital in Zanjan city. The assessment will be done by at least two people.
Participants/Inclusion and exclusion criteria
In:Patients aged 18 to 40 who have been diagnosed with Panic disorder with or without Agoraphobia, Having at least one Panic attack per week in the last month (or at least one attack per month), Proficiency in Persian language, If they receive medicine, the dose of the medicine should be constant, Willingness to treat with an analytical approach, Not receiving other psychotherapy in the last month and during the treatment, Ability to fully attend 24 treatment sessions, Patients' satisfaction and interest in participating in the study؛ Out:Dissatisfaction of patients towards starting or continuing treatment, More than two absence from treatment sessions, Depression, Bipolar, Psychotic, Personality and Substance abuse disorders were present together, Suicidal tendencies, Physical illness
Intervention groups
5 patients with panic disorder
Main outcome variables
Severity of Panic disorder symptoms; Disability due to Panic disorder

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230122057177N1
Registration date: 2023-02-20, 1401/12/01
Registration timing: prospective

Last update: 2023-02-20, 1401/12/01
Update count: 0
Registration date
2023-02-20, 1401/12/01
Registrant information
Name
Amir hossein Rasouli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3474 8204
Email address
amirhs.rasouli@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2023-07-22, 1402/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of panic-focused psychodynamic psychotherapy on emotional awareness and interpersonal problems in predicting improvements of panic symptoms and related disability
Public title
The effects of panic-focused psychodynamic psychotherapy on Panic disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18 to 40 who have been diagnosed with Panic disorder with or without Agoraphobia Having at least one Panic attack per week in the last month (or at least one attack per month) Proficiency in Persian language If they receive medicine, the dose of the medicine should be constant Willingness to treat with an analytical approach Not receiving other psychotherapy in the last month and during the treatment Ability to fully attend 24 treatment sessions Patients' satisfaction and interest in participating in the study
Exclusion criteria:
Dissatisfaction of patients towards starting or continuing treatment More than two absence from treatment sessions Depression, Bipolar, Psychotic, Personality and Substance abuse disorders were present together Suicidal tendencies Physical illness
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 5
Randomization (investigator's opinion)
N/A
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 Zanjan University of Medical Sciences
Street address
Dr.Beheshti Psychiatrc Hospital, Ark Square, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4513615788
Approval date
2023-01-03, 1401/10/13
Ethics committee reference number
IR.ZUMS.REC.1401.308

Health conditions studied

1

Description of health condition studied
Panic disorder
ICD-10 code
F41.0
ICD-10 code description
Panic disorder [episodic paroxysmal anxiety] without agoraphobia

Primary outcomes

1

Description
Panic Disorder Severity
Timepoint
Once a week
Method of measurement
Panic Disorder Severity Scale (PDSS)

2

Description
Disability caused by Panic disorder
Timepoint
Once a week
Method of measurement
Sheehan Disability Scale (SDS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: including five patients with Panic disorder who receive Panic-Focused Psychodynamic Psychotherapy (PFPP) twice a week for 24 sessions and during this time they are evaluated once a week.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr.Beheshti Psychiatric Hospital
Full name of responsible person
Mazaher Rezaei
Street address
Dr.Beheshti Psychiatric Hospital, Ark Square, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3354 4001
Fax
+98 24 3354 2403
Email
libbeheshti@zums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr.Samad Nadri
Street address
Dr.Beheshti Psychatric Hospital, Ark Square, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3354 4001
Fax
+98 24 3354 2403
Email
libbeheshti@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
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
Zanjan University of Medical Sciences
Full name of responsible person
Dr.Mazaher Rezaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Department of Clinical Psychology, Dr.Beheshti Psychiartic Hospital, Ark Square, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3354 4001
Email
mazrez@zums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr.Mazaher Rezaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Department of Clinical Psychology, Dr.Beheshti Psychiatric Hospital, Ark Square, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3354 4001
Email
mazrez@zums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Mazaher Rezaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Department of Clinical Psychology, Dr. Beheshti Psychiatric Hospital, Ark Square, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3354 4001
Email
mazrez@zums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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