Protocol summary

Study aim
Determining the effectiveness of the intervention based on the cognitive-behavioral treatment model of panic attack in co-occurring heart diseases (PATCHD) on the risk factors of cardiovascular disease
Design
Randomized clinical trial with a waiting list control group, without blinding
Settings and conduct
The statistical population of this research is all the cardiovascular patients referred to Qaim Hospital (AS) in Mashhad who are diagnosed with panic disorder based on structured clinical interview based on DSM-5. People who have full symptoms of panic disorder and are willing to participate in the research are selected as samples. All participants will complete a written informed consent form.
Participants/Inclusion and exclusion criteria
Inclusion criteria: (1) having symptoms of panic disorder and cardiovascular diseases at the same time (2) being at least 18 years old (3) not undergoing psychiatric (drug) and psychological treatments at the same time, or completing previous psychological treatments until 6 months before entering the study (4) not suffering from severe mental disorders. Exclusion criteria: (1) patient's lack of consent to continue cooperation (2) commencing psychiatric or psychological treatment (3) absence of more than 2 sessions in treatment sessions
Intervention groups
Intervention and control group: 40 panic patients with cardiovascular disease. For the intervention group, 8 90-minute intervention sessions based on the cognitive-behavioral treatment model of panic attack in co-occurring heart diseases will be held once a week, and no intervention will be conducted for the control group.
Main outcome variables
Anxiety, depression, blood pressure, diabetes, blood lipid profile, inflammation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220521054950N2
Registration date: 2024-10-02, 1403/07/11
Registration timing: retrospective

Last update: 2024-10-02, 1403/07/11
Update count: 0
Registration date
2024-10-02, 1403/07/11
Registrant information
Name
Mohsen Moohebati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3801 2465
Email address
mouhebatim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of the cognitive-behavioral treatment-based model of Panic Attack Treatment in Comorbid Heart Diseases (PATCHD) on the risk factors of cardiovascular disease
Public title
The effectiveness of cognitive-behavioral therapy on cardiovascular disease risk factors
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having symptoms of panic disorder and cardiovascular diseases at the same time being at least 18 years old Not undergoing psychiatric (drug) and psychological treatments at the same time, or completing previous psychological treatments up to 6 months before entering the study Not suffering from severe mental disorders
Exclusion criteria:
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation Concealment Method: Using opaque, sealed envelopes with random sequences, where each generated random sequence is recorded on a card, and the cards are placed inside the envelopes in order. The envelopes are numbered in the same order on the outside to maintain the random sequence. Finally, the envelopes are sealed and placed in an orderly box. When the participant registration begins, based on the order of eligible participants entering the study, one of the envelopes is opened sequentially, revealing the assigned group for that participant. Randomization: Participants are divided into one of two intervention/control groups using PASS software in a 4-block method with the same allocation. Participants who enter the study choose an opaque, sealed envelope containing a random assignment to the intervention or control group. 20 people are included in the experimental group and 20 people in 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
Ethics Committee of Mashhad University of Medical Sciences
Street address
Ahmedabad Blvd., Qaem Hospital
City
Khorasan Razavi
Province
Razavi Khorasan
Postal code
99199-91766
Approval date
2024-08-11, 1403/05/21
Ethics committee reference number
IR.MUMS.IRH.REC.1403.083

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

2

Description of health condition studied
cardiovascular disease
ICD-10 code
P29
ICD-10 code description
Cardiovascular disorders originating in the perinatal period

Primary outcomes

1

Description
anxiety
Timepoint
One day before the intervention and one day after the intervention
Method of measurement
Beck's 21-question anxiety questionnaire

2

Description
depression
Timepoint
One day before the intervention and one day after the intervention
Method of measurement
Patient health questionnaire

3

Description
blood pressure
Timepoint
One day before the intervention and one day after the intervention
Method of measurement
Mercury sphygmomanometer

4

Description
diabetes
Timepoint
One day before the intervention and one day after the intervention
Method of measurement
Venous blood sample

5

Description
Blood lipid profile
Timepoint
One day before the intervention and one day after the intervention
Method of measurement
Venous blood sample

6

Description
inflammation
Timepoint
One day before the intervention and one day after the intervention
Method of measurement
Venous blood sample

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 1-2 session: evaluation and case formulation; Education about heart disease, risk factors and anxiety. 3-4 session: improving coping skills; Reducing behavioral and situational avoidance. 5-6 session: Visceral exposures - starting a supervised exercise program; Mindfulness. 7-8 session: Cognitive Restructuring - Identifying Central Thoughts and Beliefs That Influence Panic Symptoms
Category
Treatment - Other

2

Description
Control group: This group is placed on the waiting list.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Qaem Hospital
Full name of responsible person
Mohsen Mohebati
Street address
Ahmadabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3858 3854
Email
mouhebatim@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Deputy of Research and Technology of the University, Qurashi Building, Next to Hoveyzeh Cinema, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
TafaghodiM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Mohebati
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Ahmadabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3858 3854
Email
mouhebatim@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Mohebati
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Ahmadabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3858 3854
Email
mouhebatim@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Mohebati
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Ahmadabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3858 3854
Email
mouhebatim@mums.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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