Calculating the Contribution of Flexibility Components in Predicting Sexual Distress and Satisfaction Based on Intimacy and Attachment Orientation in Men with Sexual Dysfunction and Investigating the Efficacy of Acceptance and Commitment Therapy Based on the Most Contributions Components on Sexual Distress and Satisfaction in Men Recovered from Peyronie's Disease
Determining the efficacy of Acceptance and Commitment Therapy based on the most contributions components on sexual distress and satisfaction in men recovered from peyronie’s disease
Design
The clinical trial does not have a control group, unblinded, and non-randomized. The intervention is performed on 3 patients
Settings and conduct
The clinical trial is conducted in the family health clinic of Shahid Mostafa Khomeini Hospital, during 4 weekly sessions and individually.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Having at least a diploma; Being sexually active; Existence of high sexual distress and low sexual satisfaction
Exclusion Criteria: Absence of one session of treatment sessions; Suffering from severe psychological disorders; Suffering from sexual dysfunction; History of diabetes, cardiovascular and neurological diseases; History of prostate or pelvic surgery; Drug and alcohol addiction; Taking psychiatric medications
Intervention groups
Considering that this study using single-subject design, each subject is considered to be his own control group. The intervention sessions are derived from the Acceptance and Commitment Therapy Manual for Anxiety Disorders. This manual is an integrated, transdiagnostic protocol for a wide range of anxiety disorders that has previously been used to improve distress and increase marital satisfaction. In the aforementioned study, the main protocol has experienced changes to adapt to the research sample and study objectives, and in the current study, changes are also applied to adapt the content of the treatment protocol to the problems of Peyronie's patients.
Main outcome variables
The score that a person obtains in the sexual anxiety and sexual depression subscales of the Multidimensional Sexuality Questionnaire; Individual's score in the sexual satisfaction subscale of the Multidimensional Sexuality Questionnaire
General information
Reason for update
Acronym
ACT
IRCT registration information
IRCT registration number:IRCT20240705062335N1
Registration date:2024-08-12, 1403/05/22
Registration timing:prospective
Last update:2024-08-12, 1403/05/22
Update count:0
Registration date
2024-08-12, 1403/05/22
Registrant information
Name
Mohammad Ahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3523 2064
Email address
mohammad-ahmadi@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2024-10-21, 1403/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Calculating the Contribution of Flexibility Components in Predicting Sexual Distress and Satisfaction Based on Intimacy and Attachment Orientation in Men with Sexual Dysfunction and Investigating the Efficacy of Acceptance and Commitment Therapy Based on the Most Contributions Components on Sexual Distress and Satisfaction in Men Recovered from Peyronie's Disease
Public title
Investigating the Effect of Acceptance and Commitment Therapy (ACT) in Peyronie’s Disease
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least a diploma
Being sexually active
Existence of high sexual distress and low sexual satisfaction based on the Multidimensional Sexuality Questionnaire (MSQ)
Exclusion criteria:
Absence of one session of treatment sessions
Suffering from severe psychological disorders based on the SCL90 questionnaire
Suffering from sexual dysfunction based on the BMSFI screening questionnaire and clinical interview
History of diabetes, cardiovascular and neurological diseases
History of prostate or pelvic surgery
Drug and alcohol addiction
Taking psychiatric medications
Age
From 25 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
3
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahed university Committee for Ethics in Research
Street address
Shahed University, opposite Holy shrine of Imam Khomeini, Khalij Fars Expressway
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2024-05-27, 1403/03/07
Ethics committee reference number
IR.SHAHED.REC.1403.022
Health conditions studied
1
Description of health condition studied
Peyronie
ICD-10 code
N48.6
ICD-10 code description
Induration penis plastica
Primary outcomes
1
Description
The score that a person obtains in the sexual anxiety and sexual depression subscales of the Multidimensional Sexuality Questionnaire
Timepoint
Measuring sexual anxiety and sexual depression before starting the intervention and 7, 14, 21, 28 and 60 days after starting to receive the Acceptance and Commitment Therapy
Method of measurement
Multidimensional Sexuality Questionnaire
2
Description
Individual's score in the sexual satisfaction subscale of the Multidimensional Sexuality Questionnaire
Timepoint
Measuring sexual satisfactory before starting the intervention and 7, 14, 21, 28 and 60 days after starting to receive the Acceptance and Commitment Therapy
Method of measurement
Multidimensional Sexuality Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: considering that the current study is a single case intervention, therefore each subject is considered his own control group. In this study, 3 subjects are subjected to a pre-test before the start of the study, and after receiving treatment based on acceptance and commitment, they are evaluated in 4 sessions.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Family Health Clinic of Shahid Mostafa Khomeini Hospital