Intervention Based on the Cognitive Behavioral Therapy Model of Panic Attack Treatment in Comorbid Heart Diseases (PATCHD) and Exploring Patients' Experience of Treatment: A Mixed-Method Approach
To determine the effect of intervention based on the PATCHD model on the symptoms of panic disorder in cardiovascular patients
Design
A randomized controlled trial will use the Excel software rand function for randomization.
Settings and conduct
The participants are randomly assigned to the experimental and control groups of the waiting list. The intervention is carried out in 8 sessions of 90 minutes as a group on the experimental group. Before and after the intervention, the experimental and control group patients will complete the waiting list of the panic disorder severity scale.
Participants/Inclusion and exclusion criteria
Inclusion criteria: (1) have symptoms of panic disorder and cardiovascular disease, (2) be at least 18 years old, (3) not be undergoing simultaneous psychiatric treatment (pharmacological), and it is important that psychological therapies and previous psychological therapies must have been completed up to 6 months before the start of the treatment, (4) not be suffering from severe mental disorders (e.g. psychosis, bi-polar depression, dementia).
Exclusion criteria: (1) patients’ dissatisfaction with continued cooperation, (2) initiation of simultaneous psychiatric or psychological treatment, and (3) absence of more than two sessions in treatment sessions.
Intervention groups
Participants will be randomly assigned to one of two groups intervention group or waitlist control group. The randomization sequence will be generated by a statistical program random sequence in blocks of 3.
Main outcome variables
Panic Disorder Severity
General information
Reason for update
Acronym
PATCHD
IRCT registration information
IRCT registration number:IRCT20220925056036N1
Registration date:2022-11-14, 1401/08/23
Registration timing:prospective
Last update:2022-11-14, 1401/08/23
Update count:0
Registration date
2022-11-14, 1401/08/23
Registrant information
Name
Sajjad Bodaghi
Name of organization / entity
The University of Shahid Beheshti
Country
Iran (Islamic Republic of)
Phone
+98 51 3274 5902
Email address
s_bodaghi@sbu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Intervention Based on the Cognitive Behavioral Therapy Model of Panic Attack Treatment in Comorbid Heart Diseases (PATCHD) and Exploring Patients' Experience of Treatment: A Mixed-Method Approach
Public title
Intervention Based on the Cognitive Behavioral Therapy Model of Panic Attack Treatment in Comorbid Heart Diseases (PATCHD) and Exploring Patients' Experience of Treatment: A Mixed-Method Approach
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Have symptoms of panic disorder and cardiovascular disease
Be at least 18 years old
Not be undergoing simultaneous psychiatric treatment (pharmacological), and it is important that psychological therapies and previous psychological therapies must have been completed up to 6 months before the start of the treatment
Not be suffering from severe mental disorders (e.g. psychosis, bi-polar depression, dementia)
Exclusion criteria:
Patients’ dissatisfaction with continued cooperation
Initiation of simultaneous psychiatric or psychological treatment
Absence of more than two sessions in treatment sessions
Age
From 18 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
Randomization will be done using Excel software. halve the number of participants and enter in tow columns 1 and 2. in the second column, we generate a random number using the Rand function option; then we sort the data by their values(ascending or descending). according to the order of numbers 1 and 2, the samples are randomly assigned to two groups.
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
Ibn Sina Hospital, Horr Ameli Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983134
Approval date
2022-10-25, 1401/08/03
Ethics committee reference number
IR.MUMS.REC.1401.244
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
Severity of panic disorder
Timepoint
Before and after the intervention and after 3 months after the intervention
Method of measurement
Panic Disorder Severity Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention will be implemented based on the model of cognitive-behavioral treatment of panic attacks in concomitant heart diseases (PATCHD). This intervention will be implemented in 8 sessions as a group. This model includes six components: (1) case formulation; (2) psychoeducation about heart disease and anxiety; (3) mindfulness-based stress reduction; (4) promoting coping skills and action plans for chest pain; (5) exposures to the opposite of avoidant behavior (situational and visceral, including a supervised physical exercise program), and (6) cognitive interventions designed to address the maladaptive and alarmist thought patterns that perpetuate panic and avoidance. The intervention will be implemented during 8 sessions of 90 minutes for 8 weeks.
Category
Behavior
2
Description
Control group: routin care
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital Mashhad
Full name of responsible person
Sajjad Bodaghi
Street address
Ahmadabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0001
Email
b.ghaem@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Shahid Beheshti
Full name of responsible person
Seyedeh Mehri Hamidi
Street address
Shahid Shahriari Square, Evin
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 29901
Email
pr-office@sbu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Shahid Beheshti
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
The University of Shahid Beheshti
Full name of responsible person
Sajjad Bodaghi
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Horr Ameli Blvd, Ebn'e Sina Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9148964467
Phone
+98 51 3274 5902
Email
s_bodaghi@sbu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Shahid Beheshti
Full name of responsible person
Sajjad Bodaghi
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Ebn'e Sina Hospital, Horr Ameli Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983134
Phone
+98 51 3274 5902
Email
s_bodaghi@sbu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
The University of Shahid Beheshti
Full name of responsible person
Sajjad Bodaghi
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Horr Ameli Blvd, Ebn'e Sina Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983134
Phone
+98 51 3274 5902
Email
s_bodaghi@sbu.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