Comparison of cognitive group therapy and its combination with self-management program in reducing of depression, anxiety, aggression and pain of women with chronic pain
Objective: The aim of this study was to compare effectiveness of cognitive group therapy and its combination with self-management program in reducing depression, anxiety, aggression and pain in women with chronic pain. Design: Statistical population consisted of all women with chronic pain musculoskeletal pain, recruited through Emam Reza Treatment Center Clinics, Quaem Treatment Clinic Center and the Clinical Psychology and Counseling Center at the Ferdowsi University of Mashhad. Thirty women with chronic pains were selected via judgmental sampling. Setting and conduct: It was used DASS-21, Aggression questionnaire and Multidimensional Pain Inventory for collecting data. 30 women with chronic pains were selected and they were assigned randomly in to two experimental groups and one control group. The treatment consisted of cognitive group therapy and cognitive pain self-management that consisted of eight 120-min weekly group sessions in each session. The intervention was performed on the Clinical Psychology and Counseling Center at the Ferdowsi University of Mashhad (Iran).
Participants: Eligibility criteria were age between 18-50 years, suffered from chronic non specific pain and had pain for at least three months. Exclusion criteria comprised of unwillingness to participants, severe somatic illness requiring specific treatment and manifest psychiatric disorder. Intervention: The treatments consisted of cognitive group therapy and its combination with self-management program. Primary outcome variables are depression, anxiety, aggression and pain.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015111924265N2
Registration date:2016-07-13, 1395/04/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-07-13, 1395/04/23
Registrant information
Name
Faezeh Salayani
Name of organization / entity
Ferdowsi University of Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 51 3731 2892
Email address
fa.salayani@stu.um.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2014-10-23, 1393/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of cognitive group therapy and its combination with self-management program in reducing of depression, anxiety, aggression and pain of women with chronic pain
Public title
Comparison of cognitive therapy and cognitive pain self-management program in depression, anxiety, aggression and pain of women with chronic pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ages 18-50 years, suffered from chronic non specific pain, had pain for at least three months, ability to complete self-assessment questionnaires, provision of written, signed informed consent; Exclusion criteria: unwillingness to participants, severe somatic illness requiring specific treatment, manifest psychiatric disorder such as psychosis, failed inclusion criteria, use of stimulants, drugs, alcohol at the time of the study.
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Participants were selected via judgmental sampling and they were randomly assigned randomly into three groups of 10 as two experimental and one control groups. The way of randomization was done by Simple Random Sampling. A sample is called simple random sample if each unit of the population has an equal chance of being selected for the sample. Lottery method was used for the selection of a simple random sample.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ferdowsi University of Mashhad
Street address
faculty of pschology, Ferdowsi University of Mashhad, Azadi Sq, Mashhad
City
Mashhad
Postal code
Approval date
2014-06-10, 1393/03/20
Ethics committee reference number
567
Health conditions studied
1
Description of health condition studied
chronic pain
ICD-10 code
R52.9
ICD-10 code description
Generalized pain NOS
Primary outcomes
1
Description
depression
Timepoint
before intervention and two months later
Method of measurement
DASS-21 Questionnaire
2
Description
Anxiety
Timepoint
before intervention and two months later
Method of measurement
DASS-21 Questionnaire
3
Description
Aggression
Timepoint
before intervention and two months later
Method of measurement
Aggression Questionnaire (AQ)
4
Description
Pain
Timepoint
before intervention and two months later
Method of measurement
Multidimensional Pain Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Cognitive group therapy
treatment sessions comprised of eight 120 min group session.Protocol consisted of cognitive therapy protocol based on Michel Free. Session-by-session outlines are presented:
Session 1: Introduction and ground rules, teach ABC model; Session 2: Identifying of automatic thoughts and logical errors ;
Session 3: Welcome and reflections from last session, identifying negative schema content using the vertical arrow method;
Session 4: Welcome and reflections from last session, making a master list of negative beliefs and cognitive maps;
Session 5: Welcome and reflections from last session, beliefs that have changed, utility analysis, investigatory Analysis;
Session 6: Welcome and reflections from last session, making counters, hierarchy construction ; Session 7: Welcome and reflections from last session, changing negative beliefs;
Session 8: Welcome and reflections from last session, self punishment, using imagery, review of the program, get feedback about the treatment plan
Category
Behavior
2
Description
Intervention group 2: combination of cognitive therapy with self-management program.
Treatment session was comprised of eight 120 min group session . Protocol consisted of cognitive therapy protocol based on Michel Free and the chronic disease self-management program (CDSMP) protocol that originally developed by Lorig et al. Session-by-session outlines are presented:
Session 1: Introduction and ground rules, teach ABC model; Session 2: Identifying of automatic thoughts and logical errors, boom and bust over\under activity and exercise, breathing, being more active, goal setting and planning for action;
Session 3: Welcome and reflections from last session, identifying negative schema content using the vertical arrow method, give an overview of good nutrition and a rationale for eating better, goal setting and planning for action;
Session 4: Welcome and reflections from last session, making a master list of negative beliefs and cognitive maps, using Mind to Manage Symptoms and Distraction, goal setting and planning for action;
Session 5: Welcome and reflections from last session , beliefs that have changed, utility analysis, investigatory Analysis, muscle Relaxation, goal setting and planning for action;
Session 6: Welcome and reflections from last session, making counters, hierarchy construction; problem-Solving skill, communication Skills, goal setting and planning for action;
Session 7: Welcome and reflections from last session, changing negative beliefs; depression management, guided Imagery, goal setting and planning for action;
Session 8: Welcome and reflections from last session, self punishment, using imagery, review of the program, get feedback about the treatment plan
Category
Behavior
3
Description
control group: Control group did not receive any treatment and after the initial eight-week delay, all those in the control group condition received the intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Treatment Center Clinics
Full name of responsible person
Dr Sima Eftekharzadeh
Street address
Emam Reza treatment Center Clinic, Emam Reza Square, Ebne Sina Avenue, Mashhad, Iran
City
Mashhad
2
Recruitment center
Name of recruitment center
Quaem Treatment clinic center
Full name of responsible person
Dr hossein mashhadi nejad
Street address
Quaem Treatment clinic center, Ahmad Abad Ave, Ali Shariati Sq(Taghi Abad Sq), Mashhad
City
Mashhad
3
Recruitment center
Name of recruitment center
Clinical Psychology and counseling Center at school of psychology
Full name of responsible person
Dr.Seeyed Mohsen Asgari Nekah
Street address
Clinical Psychology and counseling Center, Ferdowsi University of Mashhad, Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Ferdowsi University of Mashhad
Full name of responsible person
Bahrami Ahmad
Street address
Vice president for research, Ferdowsi University of Mashhad , Azadi, Sq, Mashhad, Iran
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research Ferdowsi University of Mashhad
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Faezeh Salayani
Position
Master in family counseling
Other areas of specialty/work
Street address
faculty of education and psychology, Ferdowsi University of Mashhad, Azadi Sq, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 3880 5869
Fax
Email
fa.salayani@stu.um.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Mohammad Javad Asghari EbrahimAbad
Position
phd
Other areas of specialty/work
Street address
Faculty of education and psychology, Ferdowsi University of Mashhad, Azadi Sq, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 3880 5869
Fax
Email
mjasghari@um.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Faezeh Salayani
Position
Master in family counseling
Other areas of specialty/work
Street address
Mashhad
City
faculty of education and psychology, Fersowsi University of Mashhad,Azadi Sq, Mashhad, Iran
Postal code
Phone
+98 935 557 1733
Fax
Email
fa.salayani@stu.um.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)