Protocol summary

Study aim
Investigating the effectiveness of a group intervention based on acceptance and commitment on reducing sexual avoidance and improving sexual satisfaction, marital happiness, and quality of life in people with sexual desire/arousal disorder
Design
Randomized controlled clinical trial with three parallel groups, on 75 participants, block randomization method using Random Allocation Software, without blinding
Settings and conduct
This study will be conducted at the Department of Sexual Health of Iran in Tehran. Individuals with sexual desire/arousal disorder will be enrolled in the study. After initial assessments, participants will be randomly assigned to three intervention groups: an acceptance and commitment-based intervention, an attention control, and a no-intervention control. The intervention group will receive 8 weekly 90-minute sessions of acceptance and commitment-based group therapy, and the attention control group will participate in 8 weekly sessions of non-specific education and support. Assessments will be conducted at pre-intervention, post-intervention, and three months after the end of the intervention.
Participants/Inclusion and exclusion criteria
Married individuals aged 20 to 45 with sexual desire/arousal disorder will be included in the study. Individuals who miss more than one session, fail to cooperate in follow-ups, and have sudden changes in physical or mental status will be excluded.
Intervention groups
Intervention group: Participants will receive 8 weekly 90-minute sessions of acceptance and commitment therapy (ACT). Attention control group: Participants will receive 8 weekly 90-minute sessions of non-specific education and support. Control group without intervention: Participants will receive no intervention during the study period.
Main outcome variables
Sexual avoidance, Sexual satisfaction

General information

Reason for update
Acronym
ACT
IRCT registration information
IRCT registration number: IRCT20260606069671N1
Registration date: 2026-06-12, 1405/03/22
Registration timing: prospective

Last update: 2026-06-12, 1405/03/22
Update count: 0
Registration date
2026-06-12, 1405/03/22
Registrant information
Name
Mitra Mirlohian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7720 3362
Email address
mirlohianm@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-06-22, 1405/04/01
Expected recruitment end date
2026-10-23, 1405/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effectiveness of acceptance and commitment group intervention on sexual avoidance, sexual satisfaction, marital happiness, and quality of life in individuals with sexual interest/arousal disorder
Public title
The effect of group psycotherapy of acceptance and commitment on sexual interest and arousal problems
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of sexual interest/arousal disorder based on clinical interview and DSM-5 criteria Being married Having at least a high school diploma Not receiving concurrent psychotherapeutic interventions targeting sexual functioning Not receiving concurrent pharmacological treatments affecting sexual functioning No severe physical illness affecting sexual functioning No severe psychiatric disorder based on clinical interview
Exclusion criteria:
Presence of severe psychiatric disorders based on clinical interview Presence of severe physical illnesses affecting sexual functioning Concurrent participation in psychotherapeutic interventions targeting sexual problems Concurrent use of medications affecting sexual functioning Inability to regularly attend treatment sessions
Age
From 20 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
After completion of baseline assessments, eligible participants will be randomly allocated in equal proportions to the Acceptance and Commitment Therapy (ACT) group, attention-control group, and no-intervention control group using block randomization with a fixed block size of six. The random allocation sequence will be generated using Random Allocation Software. Participants will be assigned according to the pre-generated random sequence to ensure balance in group sizes throughout the recruitment process.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University
Street address
22 Bahman Blvd, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2026-05-24, 1405/03/03
Ethics committee reference number
IR.TABRIZU.REC.1405.019

Health conditions studied

1

Description of health condition studied
Sexual Interest/Arousal Disorder
ICD-10 code
F52.2
ICD-10 code description
Sexual arousal disorders

Primary outcomes

1

Description
Sexual Avoidance Score
Timepoint
Before the intervention, immediately after the end of the 8 intervention sessions, and 3 months after the end of the intervention
Method of measurement
Rost and Glombok Sexual Satisfaction Questionnaire, Sexual Avoidance Subscale

2

Description
Sexual satisfaction score
Timepoint
Before the intervention, immediately after the end of the 8 intervention sessions, and 3 months after the end of the intervention
Method of measurement
Larson Sexual Satisfaction Questionnaire

Secondary outcomes

1

Description
Quality of life score
Timepoint
Before the intervention, immediately after the end of the 8 intervention sessions, and 3 months after the end of the intervention
Method of measurement
World Health Organization Quality of Life Questionnaire, short version

2

Description
Marital happiness score
Timepoint
Before the intervention, immediately after the end of the 8 intervention sessions, and 3 months after the end of the intervention
Method of measurement
Azerin Marital Happiness Questionnaire

Intervention groups

1

Description
Intervention Group 1: Participants will receive eight weekly 90-minute group-based Acceptance and Commitment Therapy sessions. The intervention is based on the Hexaflex model and includes acceptance of internal experiences, cognitive defusion, present-moment awareness, self-as-context, values clarification, and committed action in the context of intimate relationships and sexual concerns. Sessions will be conducted in a group format by a trained therapist.
Category
Behavior

2

Description
Intervention Group 2: Participants will receive eight weekly 90-minute supportive and educational sessions. Session content includes general mental health education, stress management, sleep hygiene, communication skills, and sexual health literacy. These sessions are matched to the intervention group in terms of number and duration but do not include the specific therapeutic components of Acceptance and Commitment Therapy.
Category
Placebo

3

Description
Control group: Participants will receive no psychological or educational intervention during the study period and will only take part in the assessment procedures. After completion of the study, they will be offered the therapeutic intervention if they wish to receive it.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Iran's Department of Sexual Health
Full name of responsible person
Sara Soleymani
Street address
No. 6, Bayan physicians building, Bayan Alley, Shariati street
City
Tehran
Province
Tehran
Postal code
1234567891
Phone
+98 21 2287 0722
Email
sarasoleimane@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University
Full name of responsible person
Abolfazl Majnooni Haris
Street address
22 Bahman blvd, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3334 0081
Email
majnooni@tabrizu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University
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
Tabrzi University
Full name of responsible person
Majid Mahmoud Alilou
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
22 Bahman blvd, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3334 0081
Email
M-alilou@tabrizu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University
Full name of responsible person
Abai Bkhshipour Roudsari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
22 Bahman blvd, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3334 0081
Email
bakhshipour@tabrizu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University
Full name of responsible person
Mitra Mirlohian
Position
PhD Candidate
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No 9, 68 square, Narmak
City
Tehran
Province
Tehran
Postal code
123456980
Phone
+98 21 7720 3362
Email
mirlohianm@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
De-identified individual participant data. The dataset will include demographic characteristics, baseline data, primary and secondary outcome measures, and variables required to reproduce the study findings. All personal identifiers will be removed prior to data sharing. Data will be available after publication of the primary study results upon reasonable request, submission of a scientific rationale, and approval by the corresponding author.
When the data will become available and for how long
After publishing the paper
To whom data/document is available
Researchers, faculty members, graduate students, research institutions, academic centers, and other applicants with legitimate scientific and research purposes may request access to the study data and documents. Requests will be reviewed based on the intended use of the data and will be granted upon approval by the corresponding author and in accordance with ethical and confidentiality requirements.
Under which criteria data/document could be used
The study data and documents may be used solely for scientific, research, and educational purposes. Applicants must provide a written description of the intended use of the data, research question, analytical approach, and planned use of the documents. The data may not be used to identify participants, for commercial purposes, transferred to third parties without permission, or used in any manner inconsistent with research ethics principles. All data will be provided in a de-identified format, and recipients will be required to maintain confidentiality and appropriately acknowledge the original study in all reports and publications arising from the shared data.
From where data/document is obtainable
contacting the corresponding author mirlohianm@gmail.com
What processes are involved for a request to access data/document
Applicants should submit their requests by email to the corresponding author. The request should include the applicant’s details, institutional affiliation, the purpose of the data or document use, the research question, and the analysis plan. Requests will be reviewed for scientific merit, ethical considerations, and confidentiality requirements. A decision will be communicated within 4 weeks. If approved, the requested data or documents will be provided in an appropriate format after removal of all identifying information and shared via email or another secure transfer method.
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