Integrative Body-Mind-Spirit Group Intervention for Infertile Couples

NCT05091450 | Unknown

• 1 other identifier: EA210488
• Study Type: interventional
• Target: 356
• Locations: 1 country
• Sites: 1

Brief Summary

This is a two-arm, with equal randomization, parallel randomized controlled trial. It compares the efficacy of a couple-based Integrative Body-Mind-Spirit (I-BMS) group intervention to a waitlist control group in improving dyadic couple flourishing and fertility-related quality of life among couples who are diagnosed of infertility in Hong Kong. It also aims to investigate the dyadic associations between infertile husbands' and wives' baseline primary outcomes and changes in primary outcomes following the intervention.

Conditions

Infertility

Outcome Measures

Primary Outcomes (2)

• Changes over the measurement points in the Couple Flourishing Measure

  It has 16 items measuring participants' perceived encouragement towards expanding goals, recognition of partner's strengths, and engagement in meaningful activities with their partner. Scores range from 16 to 112, where a higher score represents a higher level of couple flourishing.

  Baseline, post-intervention: 4 weeks after the intervention initiation, 1-month follow-up, 5-year follow-up

• Changes over the measurement points in the Fertility Quality of Life Questionnaire - Core FertiQoL subscale

  It has 24 items measuring the consequences of fertility problems on quality of life over four life domains (emotional, mind/body, relational, and social). Subscale scores range from 0 to 100, where a higher score represent a higher level of fertility quality of life.

  Baseline, post-intervention: 4 weeks after the intervention initiation, 1-month follow-up, 5-year follow-up

Secondary Outcomes (6)

• Changes over the measurement points in the Interpersonal Reactivity Index

  Baseline, post-intervention: 4 weeks after the intervention initiation, 1-month follow-up, 5-year follow-up

• Changes over the measurement points in the Relationship Flourishing Scale

  Baseline, post-intervention: 4 weeks after the intervention initiation, 1-month follow-up, 5-year follow-up

• Changes over the measurement points in the Brief Version of the Dyadic Adjustment Scale

  Baseline, post-intervention: 4 weeks after the intervention initiation, 1-month follow-up, 5-year follow-up

• Changes over the measurement points in the Hospital Anxiety and Depression Scale

  Baseline, post-intervention: 4 weeks after the intervention initiation, 1-month follow-up, 5-year follow-up

• Changes over the measurement points in the Infertility Questionnaire - Guilt/Blame subscale

  Baseline, post-intervention: 4 weeks after the intervention initiation, 1-month follow-up, 5-year follow-up

Other Outcomes (10)

• Satisfaction with Treatment Program Scale

  Post-intervention: 4 weeks after the intervention initiation

• Demographics

  Enrolment: up to 8 weeks

• Infertility information: Cause of infertility

  Enrolment: up to 8 weeks

Study Arms (2)

Couple-based I-BMS intervention for infertility

EXPERIMENTAL

The I-BMS intervention will be conducted face-to-face and in group format. It comprises four 3-hour sessions within one month. Two registered social workers who are professionally trained on I-BMS intervention model will deliver the intervention.

Behavioral: Couple-based I-BMS intervention for infertility

Waitlist control

OTHER

Couples allocated in the waitlist control group will begin the I-BMS intervention (same as the intervention group) after completing the 1-month follow-up assessment.

Behavioral: Couple-based I-BMS intervention for infertility

Interventions

Couple-based I-BMS intervention for infertility BEHAVIORAL

It is based on the previous I-BMS intervention for women undergoing IVF treatment, and aims to improve fertility quality of life and couple flourishing by (1) increasing awareness of the interconnectedness between physical and psychosocial well-being, (2) practicing body-mind-spirit techniques, (3) facilitating personal growth and partner empathy and compassion, and (3) creating the shared meaning of life, family, children. As a strength-focused and meaning-oriented approach, it utilizes experiential and self-reflective exercises to help participants reconstruct the meaning behind their ordeal and rediscover the strengths that keep them going.

Couple-based I-BMS intervention for infertility; Waitlist control

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• are in a heterosexual marriage
• are clinically diagnosed of infertility
• are actively trying to conceive
• are able to understand, read and speak Chinese
• age 18 or above
• give consent to participate in this study

You may not qualify if:

• are being exposed to intimate partner violence within the past 12 months (HARK test score \>=1)
• have signs of early psychosis within the past 12 months (Screen for Early Psychosis score = 2)
• have suicidal ideation in the past 2 weeks (Beck Depression Inventory II, item 9, score \>= 2)
• already have a living child or children

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Department of Social Work and Social Administration, The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Celia Hoi-Yan Chan, PhD

  Department of Social Work and Social Administration, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Celia Hoi-Yan Chan, PhD

CONTACT

(852) 3917 2089; chancelia@hku.hk

Victoria Ka-Ying Hui, PhD

CONTACT

(852) 3917 1832; vkyhui18@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 9, 2021
• First Posted: October 25, 2021
• Study Start: July 1, 2023
• Primary Completion: April 30, 2025
• Study Completion: June 30, 2025
• Last Updated: November 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)