Effectiveness of acceptance and commitment therapy enriched with compassion on body image, cognitive-behavioral avoidance and sexual satisfaction of patients with colorectal cancer after colostomy surgery
The aim of this study was the effectiveness of acceptance and commitment therapy enriched with compassion on body image, cognitive-behavioral avoidance and sexual satisfaction of patients with colorectal cancer after colostomy surgery.
Design
Clinical trial with purposeful sampling with no randomization, parallel groups, control group, no blinding, including 36 patients, outcome assessment
Settings and conduct
The location of research was MAKSA associated with ALA charity center in Isfahan.
Participants/Inclusion and exclusion criteria
-Entrance criteria:
1-Patients with colorectal cancer after colostomy surgery
2-Being married
-Exit criteria:
1-Diagnosed with severe mental disorders
2-Concurrent use of psychological treatments
3-Use of pyschiatric drugs from the 3 previous months
4-Have other cancers and severe physical diseases
Intervention groups
1-The experimental group received 10 sessions (weekly, 90-minute session) of acceptance and commitment therapy enriched with compassion.
2-Control group: received no treatment and standed in wait list.
Main outcome variables
body image; cognitive-behavioral avoidance; sexual satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200728048245N1
Registration date:2020-08-15, 1399/05/25
Registration timing:retrospective
Last update:2020-08-15, 1399/05/25
Update count:0
Registration date
2020-08-15, 1399/05/25
Registrant information
Name
Sheida Jabalameli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3641 4663
Email address
sh-jabalameli@iaun.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-16, 1397/01/27
Expected recruitment end date
2018-06-18, 1397/03/28
Actual recruitment start date
2018-06-21, 1397/03/31
Actual recruitment end date
2018-09-22, 1397/06/31
Trial completion date
2019-01-20, 1397/10/30
Scientific title
Effectiveness of acceptance and commitment therapy enriched with compassion on body image, cognitive-behavioral avoidance and sexual satisfaction of patients with colorectal cancer after colostomy surgery
Public title
Effectiveness of acceptance and commitment therapy enriched with compassion on psychological symptoms of patients with colorectal cancer after colostomy surgery
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with colorectal cancer after colostomy surgery
Being married
Exclusion criteria:
Diagnosed with severe mental disorders
Concurrent use of psychological treatments
Use of pyschiatric drugs from the 3 previous months
Have other cancers and severe physical diseases
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Actual sample size reached:
28
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Najafabad University
Street address
University Street
City
Najafabad
Province
Isfehan
Postal code
۸۵۱۴۱۴۳۱۳۱
Approval date
2019-01-03, 1397/10/13
Ethics committee reference number
IR.IAU.NAJAFABAD.REC.1397.093
Health conditions studied
1
Description of health condition studied
Colorectal cancer after colostomy surgery
ICD-10 code
C18.9
ICD-10 code description
Malignant neoplasm of colon, unspecified
Primary outcomes
1
Description
body image
Timepoint
Before and after treatment (2 months interval)
Method of measurement
Multi-dimensional questionnaire of individual's attitude about body image
2
Description
Cognitive-behavioral avoidance
Timepoint
before and after treatment (2 months interval)
Method of measurement
Young-Rygh Avoidance Inventory
3
Description
Sexual satisfaction
Timepoint
before and after treatment (2 months interval)
Method of measurement
Hudson Sexual Satisfaction Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: acceptance and commitment therapy enriched with compassion, 10 weekly sessions
Category
Behavior
2
Description
Control group: receive no treatment
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
MACSA
Full name of responsible person
-
Street address
Motahari street
City
Isfahan
Province
Isfehan
Postal code
8197113765
Phone
+98 31 3233 3029
Email
info@macsa.ir
Web page address
http://macsa.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sheida Jabalameli
Street address
University Street
City
Najafabad
Province
Isfehan
Postal code
۸۵۱۴۱۴۳۱۳۱
Phone
+98 31 4229 2929
Email
sh.jabalameli@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
70
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Sheida Jabalameli
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
2th Apadana
City
Isfahan
Province
Isfehan
Postal code
8166794841
Phone
+98 31 3641 4663
Fax
Email
Sh-Jabalameli@iaun.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sheida Jabalameli
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
2th Apadana
City
اصفهان
Province
Isfehan
Postal code
8166794841
Phone
+98 31 3641 4663
Fax
Email
Sh-Jabalameli@iaun.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sheida Jabalameli
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
2th Apadana
City
اصفهان
Province
Isfehan
Postal code
8166794841
Phone
+98 31 3641 4663
Fax
Email
Sh-Jabalameli@iaun.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