Comparing the Effectiveness of Mindfulness-Based Cognitive Behavioral Therapy Versus Usual Care in Reducing Anxiety and Improving Sperm Parameters (Count, Motility, and Morphology) in Infertile Men

The aim of this study is to evaluate the effectiveness of MBCT in reducing anxiety and improving sperm parameters in infertile men.

This study is a single-blind, parallel-group randomized controlled trial. Infertile men will be randomly allocated via an online randomization website to either MBCT (8 weekly 120-min sessions) or control (usual care without structured psychotherapy). The sample size is 60 (30 per group), and the trial is phase II.

Study Location: Psychological Sciences House Clinic, Mashhad, Iran. Study Population: Eligible infertile men meeting the inclusion criteria. Blinding Type: Single-blind. Blinding Method: Participants, outcome assessor, and data analyst are unaware of group allocation.

Inclusion criteria: infertility diagnosis; high anxiety on the Spielberger scale; ≥5 years since diagnosis with ongoing condition; age 25–65; written informed consent. Exclusion criteria: partner’s pregnancy; psychiatric medication in the past 3 months; psychotherapy in the past 6 months; personality disorder or psychotic symptoms

Intervention: MBCT (Group-based mindfulness-based cognitive behavioral therapy); 8 weekly 120-min group sessions, focusing on mindfulness practices (breathing, body scan, sitting meditation/mindful movement), reducing rumination and negative thoughts, cognitive restructuring and emotion regulation, plus daily home practice. Control (Usual care): Usual medical care and infertility follow-up only; no structured psychotherapy (brief stress-management info at baseline). MBCT offered after study.

State and trait anxiety scores based on the Spielberger State–Trait Anxiety Inventory (STAI); semen analysis parameters (sperm count, motility, and morphology)

Randomization will be conducted using the Randomization.com website. The random allocation sequence will be generated by an independent statistician who is not involved in study implementation or outcome assessment. Random permuted blocks with variable block sizes (4 and 6) will be used to maintain balance between the two groups: the “mindfulness-based cognitive behavioral therapy” group and the “no-intervention control” group. Allocation codes will be placed in sequentially numbered, sealed, opaque envelopes to ensure concealment of the random sequence until each participant is enrolled. Upon enrollment, the envelope corresponding to the participant’s order of entry will be opened by the staff member responsible for registration, and the participant will be assigned to the indicated group.

Randomization will be performed using the website https://www.randomization.com.The random allocation list will be generated by a statistician who is not involved in participant recruitment or outcome assessment. A block randomization method with variable block sizes (4 and 6) will be used to ensure balanced group sizes between the Gestalt Therapy group and the no-intervention control group. The allocation codes will be sealed in opaque, sequentially numbered envelopes to maintain allocation concealment until each participant is enrolled. Upon enrollment, the next envelope in sequence will be opened by the registration officer, and the participant will be assigned to the corresponding group.

A data dictionary describing the structure of the dataset (variable names, coding schemes such as intervention group=1 and control group=0, score ranges for psychological instruments, and time points such as pre-test and post-test) will be made available after completion of data collection and publication of the primary results. This file contains only variable definitions and coding rules; it does not include any identifiable participant information.

It will be available after completion of data collection and publication of the main study results in a scientific journal.

Access will be granted only to qualified researchers who provide a written request and formally agree to a confidentiality commitment

These data/documents may be used only for scientific and research purposes, such as methodological review, replication of the statistical analyses, or comparison with similar studies. Use for commercial purposes, attempts to re-identify participants, or any use outside a research context is not permitted. Access and use are conditional on a written commitment to confidentiality and non-disclosure.

Requests should be directed to the Principal Investigator of the study: Naser Aghababaei, Assistant professor. Email: Naseragha@gmail.com. Access will be considered after scientific review of the request and a signed confidentiality commitment

The requester must submit a written request to the Principal Investigator, including the research purpose, the specific data/document requested, and the intended use. The request will be reviewed for scientific merit and ethical compliance to ensure that use is strictly research-oriented and does not compromise participant confidentiality. If the request is approved, the requester will be asked to sign a confidentiality and non-disclosure agreement. After this agreement is signed, the shareable version of the data/document (with no identifying information) will be provided