a randomized clinical trial assessment between in-person and online group therapy based on acceptance and commitment therapy on anxiety, experiential avoidance and psychological flexibility using acceptance and commitment therapy in women recovered from breast cancer
Determining the effectiveness of face-to-face group therapy compared to online group therapy on anxiety, experiential avoidance and psychological flexibility using acceptance and commitment-based therapy in women recovered from breast cancer.
Design
randomized not blinded factorial group trial
Settings and conduct
The group therapy method based on acceptance and commitment is implemented during 6 group sessions, one session for the groups every week, and before the start of the sessions, at the end of the third session and at the end of the last session, questionnaires are taken from the two groups online. To implement this process treatment from the participants in the treatment; The treatment sessions are organized by a doctor of psychology at Seyed Al-Shahda Hospital in Isfahan. The experimental group performs homework such as mindfulness between sessions and the homework is discussed in the sessions. The obtained data are analyzed by t-test in SPSS software.
Participants/Inclusion and exclusion criteria
All women who have been cured of breast cancer for more than 6 months and willing to cooperate.
Intervention groups
face-to-face acceptance and commitment therapy vs online acceptance and commitment therapy
Main outcome variables
Anxiety, experiential avoidance and psychological flexibility
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221227056942N1
Registration date:2023-04-08, 1402/01/19
Registration timing:prospective
Last update:2023-04-08, 1402/01/19
Update count:0
Registration date
2023-04-08, 1402/01/19
Registrant information
Name
Mahdi Mirpourian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3331 6138
Email address
mhdmirpourian@res.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-09, 1402/01/20
Expected recruitment end date
2024-04-08, 1403/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
a randomized clinical trial assessment between in-person and online group therapy based on acceptance and commitment therapy on anxiety, experiential avoidance and psychological flexibility using acceptance and commitment therapy in women recovered from breast cancer
Public title
assessment of the effectiveness of face-to-face group therapy compared to online group therapy on anxiety, experiential avoidance and psychological flexibility using acceptance and commitment therapy in women recovered from breast cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female patients with grade 1 to 3 breast cancer of Seyed al-Shohad Hospital.
The chemotherapy and radiation therapy of these patients has ended.
These patients do not participate in other psychotherapy sessions
Exclusion criteria:
Reluctance to cooperate
Patients receiving chemotherapy and radiation therapy
The presence of psychiatric disorders in patients
Age
From 20 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
In this method, the study population will be randomly assigned to two intervention groups, face-to-face and online, using the double consent zelen preference method. In order to randomly assign patients to each group, the block balance method will be used, in this way, we use a block of 4 letters to make random allocation sequences and choose the number of letters in each block as 4 and choose the total number of blocks. Finally, we will have a list where the letter in front of each number indicates which group the person belongs to. The said process was done with the help of sealedenvelope website.
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
ethic committee of isfehan university of medicine
Street address
Isfehan university of medicine, Hezar jerib street, Isfehan
City
Isfehan
Province
Isfehan
Postal code
81746-73461
Approval date
2023-02-21, 1401/12/02
Ethics committee reference number
IR.ARI.MUI.REC.1401.304
Health conditions studied
1
Description of health condition studied
breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
The score of Spielberger Trait State Anxiety Questionnaire
Timepoint
before the intervention,the third and the sixth week of the intervention
Method of measurement
Spielberger Trait State Anxiety Questionnaire
2
Description
The score of Multidimensional Experiential Avoidance Questionnaire
Timepoint
before the intervention,the third and the sixth week of the intervention
The score of the comprehensive evaluation questionnaire of the ACT process
Timepoint
before the intervention,the third and the sixth week of the intervention
Method of measurement
the comprehensive evaluation questionnaire of the ACT process
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 6 weekly one-hour face-to-face group intervention therapy based on acceptance and commitment. Content of sessions: first session: productions of the mind and familiarity with anxiety, second session: creative despair and acceptance, third session: failure, fourth session: present tense, fifth session: experiential avoidance, sixth session: spiritual health and values.
Category
Treatment - Other
2
Description
Intervention group: 6 weekly one-hour sessions of online group therapy intervention based on acceptance and commitment. The content of the sessions includes the following: first session: mind productions and familiarity with anxiety, second session: creative frustration and acceptance, third session: failure, fourth session: present tense, fifth session: experiential avoidance, sixth session: spiritual health and values.