Effects of an online program about intimate and romantic relationships for people with mental disorders (AIRIKI): a study protocol for a randomized controlled trial

doi:10.21203/rs.3.rs-4322634/v1

Background

The concept of recovery has become internationally widespread. To promote personal recovery of individuals with mental disorders, it is important that they live life on their own terms. Many people with mental disorders wish to build intimate relationships and marry. However, people with mental disorders face obstacles in building such relationships and communicating with their partners. The program AIRIKI, which means “power to love,” was developed to help people with mental disorders gain confidence in building intimate relationships. The AIRIKI pilot study with one-group pre post test showed positive effects on self-esteem, hope, and communication. Therefore, the purpose of the proposed randomized controlled trial (RCT) is to determine the effects of the videoconferencing program on self-esteem, hope, and self-confidence in communication among un-married people with mental disorders.

Methods

The proposed randomized controlled trial has two arms (intervention group and control group). After baseline questionnaire assessment, participants will be allocated randomly. Within two months of allocation, the intervention group will participate in videoconferences about intimate relationships and marriage with 2–5 participants and 3 facilitators, which will last 3 h, for two days. Three facilitators will support participants in each session. The intervention group will complete a questionnaire for outcome assessment at termination and one month after the program. The control group will complete the outcome questionnaire at one month after baseline and two months after baseline. The questionnaire will include the Rosenberg Self-Esteem Scale (RSES), Herth Hope Index (HHI), and Self-confidence in Communication Scale (SCS). Control group members can participate in a videoconference program, which will be held separately from the intervention group, after completing their outcome assessments.

Discussion

This trial is the first randomized controlled trial of which we are aware to test the effects of an online program for un-married people with mental disorders to consider and discuss their romantic relationship and marriage. The results will provide information on the effectiveness of an online program for people with mental disorders to imagine their romantic relationships and marriages.

Trial registration

This trial has been registered with the UNIN Clinical Trials Registry (UMIN000052027; 2023/08/28).

intervention

intimate relationships

mental disorders

peer support

personal recovery

romantic relationships

The concept of recovery has become internationally widespread among individuals with mental disorders and healthcare professionals.¹ To promote personal recovery of individuals with mental disorders, it is important that they live life their own way.

In a survey conducted in Japan, the rate of unmarried people with mental disorders is 75%.² In contrast, the unmarried rates of those 50 years of age in Japan are 28.3% and 17.8% in men and women, respectively. ³ Moreover, the prevalence of having an intimate partner is 14% among unmarried individuals with mental disorders. Further, 68% of individuals with mental disorders who do not have intimate partners want to have one. In sum, although many Japanese people with mental disorders want to build intimate relationships, the marriage rate and the number of people with intimate partners are low.

Everyone can love one another. An intimate relationship is “an interpersonal process in which two partners express and share their feelings, thoughts, and experiences, both verbally and non-verbally, in order to learn more about themselves and each other.”.⁴ However, people with mental disorders face several barriers in establishing intimate relationships: 1) symptoms of mental illness and side effects of medication, 2) poor communication and social skills, 3) self-stigma and societal prejudice, and 4) lack of financial resources and, 5) unconducive living environments.^5,6

Support programs to help people with mental disorders overcome these barriers are scarce. A study by Cloutier et al.⁷ tested the effectiveness of a group therapy program called “power of two,” focusing on the theme of “dating,” “sex and intimacy,” and “communication,” in Canada and France. This study showed the effects of a repeated single-case experimental design on romantic functioning, mentalizing skills, and symptomatology among 27 male participants with mental disorders. Although the study results are important to support people with mental disorders in establishing and maintaining intimate relationships, it is necessary to have men and women learn together and reflect on the cultural differences between Japan and Western countries.

Based on the co-creation concept, Kageyama et al.⁸ developed the AIRIKI program for individuals with mental disorders and healthcare professionals in Japan. AIRIKI means “power to love” in Japanese, the program’s aim is to provide an opportunity for people with mental disorders to think about love and intimate relationships. The AIRIKI program involves group work and role-play, which are intended to help people with mental disorders communicate with others. A pilot study of AIRIKI showed the feasibility and psychological effects on self-esteem, recovery, and hope by employing a one-group pre-post-test design. Details of the program, development process, and preliminary assessment of feasibility and outcomes were reported by Kageyama, and colleagues⁸.

The subsequent phase of AIRIKI project is to test the effectiveness and the spread of the program. Therefore, we developed a videoconferencing AIRIKI program using ZOOM application to increase availability and accessibility to more people and geographical locations. This study aims to evaluate the effectiveness of AIRIKI program on self-esteem, hope, and confidence in communications using a randomized controlled trial (RCT) design.

Study aim

This study aims to test the effect of a videoconferencing program of AIRIKI on self-esteem, hope, and confidence in communication among people with mental disorders.

Study design:

An RCT with two arms (intervention and control) will be conducted. Random allocation will be performed after collecting baseline assessment. The control group will receive no intervention and will answer assessment questionnaires three times: at baseline (T1), one (T2), and two (T3) months after random allocation. The intervention group will participate in a videoconferencing program focused on romantic relationships for two days (3-hours per day) within two months of completing the baseline questionnaire. Moreover, they will answer the assessment questionnaires at intervention termination and one month after the intervention. The control group members can voluntarily participate in videoconferencing which will be held separate from the intervention group after completing their outcome assessments.

Random allocation and blinding

KY will prepare two random numbers sequences, one for men and one for women. A will stand for the intervention group and B for the control group. The block size will be four, with computer randomizer automatically arranging A’s and B’s for two set of blocks. The random sequences will consist of 20 blocks, one for males and one for females. M. Kusaka will ask KY to allocate study participants after collecting their doctors’ forms, participants’ written consent, and completion of baseline questionnaires by mail. KY will assign each participant according to the random numbers sequence for their sex and will inform M. Kusaka about the person’s assigned group via an E-mail.

M. Kusaka will manage the correspondence and list regarding participants group assignment. Researchers other than M. Kusaka will not be aware of the assignment. M. Kusaka and M Kageyama will enter the data using study ID. Statistical analyses will be conducted by M. Kageyama and KN.

Participants:

Study participants will be comprised of unmarried people with mental disorders interested in participating in the videoconferencing program for romantic relationships and marriage. The following inclusion criteria will be applied: 1) adults (≥ 18 years of age) diagnosed with at least one mental disorder and currently undergoing psychiatric outpatient treatment; 2) the patient decides on their own as to whether to voluntarily join the study (their psychiatrist provides a determination as to whether the patient has decision-making capacity); 3) currently unmarried; 4) able to participate in group discussion activities without difficulty using Japanese; 5) never participated in-person AIRIKI program; 6) availability of a personal computer, smartphone, or tablet-type device to access videoconference: and ability and willingness to show their face on a web camera during videoconferencing activities. Individuals who do not meet the inclusion criteria will be excluded.

Sample Size

Considering the effect size of the pilot study⁸ and feasibility, we will enter 100 participants, 50 in the intervention group and 50 in the control group. The statistical considerations for the primary analysis with a sample size of 100 participants are discussed below.

In the pilot study, the dropout rate was 6.6%. In this study, we assume a slightly higher dropout rate, estimating it to be 10%. Therefore, it is anticipated that complete data at T3 will be obtained from 90 participants. In the Mixed-effect Model for Repeated Measures (MMRM) to be used for the primary analysis, we assume parameter values based on the pilot study. Using Monte Carlo simulation with 1000 iterations, we found the confidence interval width of the intervention effect at T3, to be approximately 5.4, suggesting that a certain precision in interval estimation can be achieved.

Procedure

The flow diagram of participants is shown in Fig. 1. The procedures for recruitment, eligibility determination and enrollment will be as follows:

Potential candidates will learn about the AIRIKI RCT study via study announcements on AIRIKI homepage, Social Network Service (SNS), several self-help groups, and mental health events.

People interested in the study will send an E-mail to M. Kusaka.

M. Kusaka will contact them and schedule individual online appointment with them using ZOOM.

During the online appointment, M. Kusaka will explain the study design, what researchers will ask participants, the voluntariness of their study participation, and the privacy policy. Additionally, M. Kusaka will request them to provide doctor’s written opinion form and the study description document to their psychiatrist.

M. Kusaka will send doctors’ written opinion forms and study documents by mail to those who participated in the ZOOM interview and expressed interest in proceeding to join the study.

People who are interested in participating in the study will be informed to ask their psychiatric doctors to fill out the doctors’ opinion form.

The doctor will send the completed doctor’s opinion form to M. Kusaka by mail.

M. Kusaka will confirm the doctors’ opinions of each potential participant. Subsequently, M. Kusaka will send informed consent form and the baseline questionnaire to the participants by mail.

Participants complete a written informed consent form and baseline questionnaire (T1).

After receiving the participants’ written informed consent and the baseline questionnaire, M. Kusaka will ask KY to allocate participants using a computerized randomizer.

After random allocation, M Kusaka will inform participants by E-mail of the allocated group and the following schedule.

The intervention group will participate in the AIRIKI program within 2 months of allocation and will complete the questionnaire at termination (T2) and one month (T3) after program participation. The control group will receive questionnaires one month (T2) and two months (T3) after allocation.

After completing T3 questionnaire, the control group can participate in the AIRIKI program which will be conducted separately from the intervention group.

At the end of the study, participants will receive a coupon of 3,000 yen (approximately 20 USD) as a gesture of gratitude.

Intervention:

The videoconferencing AIRIKI program will be held during two consecutive weeks (Saturday or Sunday) on ZOOM. Each session of the day will last 3 hours. Three facilitators will support 2–5 participants together in each session. Thus, the group in each session will be comprised of 5–8 people. The facilitators will consist of two individuals diagnosed with mental disorders and one healthcare professional (either a Mental Health Nurse, Psychiatrist, or Mental Health Social Worker). Only facilitators who receive training can provide the program. Practice sessions will be held for facilitators to offer smooth teleconferencing programing on ZOOM before starting participants’ enrollment. In AIRIKI program, the facilitators will work together and talk about their own experiences of loving people. The facilitators' talk will help to bring awareness and evoke ideas to other participants.

Details of the AIRIKI program have been previously described.⁸ The program is slightly modified to be compatible with videoconferencing, which is shown in Table 1. The program will begin with the announcement by facilitators of precautions for participating in videoconferencing programs (e.g., showing their face using web camera, keeping themselves hydrated). The warm-up session will last for 20 min (e.g., introductions and discuss aims of participation). On Day 1, the participants and facilitators will share their thoughts and talk about Module 1 - What is love for you? (60 min) and Module 2 - Understand your loved one (80 min), using a textbook that was originally developed for the AIRIKI program. In Module- 1, participants will be given time to think and then express their thoughts about what love is for them, and reflect on their experience of being loved by someone who is not only a lover but also by friends and family. In Module- 2, participants will be asked to think about and discuss how they know another person. In addition, a role-playing exercise, in which participants are asked to invite their role play partner on a first date, will be conducted. At the end of Day 1, short reflections and positive feedback will be offered to each other.

On Day 2, which will be held the following week from Day 1, participants will consider Module 3 - Meeting and dating (80 min) and Module 4 - Maintaining a long-term relationship (70 min). In Module- 3, participants will be asked to think and then discuss how to find a partner and initiate an intimate relationship. Additionally, a role-playing exercise, in which participants will disclose their mental illness to their role play partner, will be practiced. In Module- 4, participants will share their thoughts and images of marriage. Finally, the program will end with participants’ reflection and positive feedback to each other. During discussion of their reflections, participants will tell their impression of the program and how they think they will act in the future and everyone will tell the other participants what they see as their strengths and positive features.

Assessment plan

1. Demographic variables

Demographic variables will be collected using baseline questionnaire. These variables will include: age, sex, cohabitation status, experience of marriage, experience with romance, having a partner or not, age at onset of mental illness, diagnosis of mental illness, treatment of mental illness, prescribed medication or not, experience of hospitalization, disability classification, and degree of social participation.

2. Outcome variables

Self-esteem

The main outcome is self-esteem, which will be measured using the Rosenberg Self-Esteem Scale (RSES). The RSES is a self-rated scale with 10 items. The validity and reliability of the Japanese version of the scale have been confirmed.^{9, 10} Participants will rate each item using a four-point Likert scale from 1 (strongly disagree) to 4 (strongly agree). The total score ranges from 10 to 40 points. Higher scores indicate greater self-esteem.

Hope

Hope is a secondary outcome, which will be measured using the Herth Hope Index (HHI)¹¹. Yamaki et al. developed the Japanese version of the HHI.¹² HHI is a four-point Likert scale ranging from 1 (completely disagree) to 4 (completely agree), with 12 items and total scores range from 12 to 48 points. HHI contains three subscales, which are “inner sense of temporary and future (4 items),” “inner positive readiness and expectancy (4 items),” and “interconnectedness with self and others (4 items).” The validity and reliability of the Japanese version of the scale have been confirmed¹².

Self-confidence in communication

Self-confidence in communication is also a secondary outcome. The Self-Confidence in Communication scale (SCS) has been developed for the general Japanese population.¹³ The SCS is a seven-point Likert scale ranging from 1 (not applied at all) to 7 (definitely applied), with 30 items. SCS has three subscales, as follows: “intention communication (9 items),” “intention restraints (9 items),” and “intention comprehension (9 items).” The contents of “I can rightly tell what I want to say to my partner (item 1)” and “I can successfully express my emotions to my partner (item 10)” are contained in “intention communication” subscale. For this study, the subscale “intention communication” will be the only portion of scale used; since it is important for the couple to communicate their own thoughts and opinion to each other, which is a target of AIRIKI program participation. The total range of this subscale is 9–63 points with higher scores being greater self-confidence in communicating.

Cronbach alpha coefficients will be calculated for all scales employed.

3. Feasibility assessment

Participants will participate in a feasibility assessment using a self-rated original questionnaire after completion of the program. The contents are as follows: any difficulties in program participation, any thoughts regarding program, accessibility, thoughts about program length, about the number of participants, and about the textbook.

Demographic variables will be collected at the baseline assessment (T1). Outcome variables will be collected at the baseline assessment (T1), following assessment 1(T2), and following assessment 2 (T3). A feasibility assessment will be conducted after the program’s completion. Table 2 shows the contents of the questionnaire.

Study hypothesis

Hypothesis 1

The main hypothesis is that the self-esteem scores at T3 will be greater for the intervention group than in the control group.

Hypothesis 2

The secondary hypothesis is that the changes in self-esteem scores from T1 to T2, and T3 will be greater in the intervention group than in the control group.

Hypothesis 3

The main hypothesis is that hope scores at T3 will be higher in the intervention group than in the control group.

The secondary hypothesis is that the changes in hope scores from T1 to T2, and T3 will be greater in the intervention group than in the control group

Hypothesis 4

The main hypothesis is that self-confidence in communication scores at T3 will be greater in the intervention group than in the control group.

The secondary hypothesis is that changes in self-confidence in communication scores from T1 to T2, and T3 will be higher in the intervention group than in the control group

Statistical analysis

We will conduct an intention-to-treat analysis (ITT), in which we will use all available data. The population for which the ITT takes place is the full analysis set (FAS). In addition, per protocol set (PPS) will be defined as the population of study subjects who do not fall under any of the following categories in the FAS; 1) if the patient received a procedure different from the original allocation; 2) failure to participate in the AIRIKI program within 2 months of allocation; and 3) if the patient withdraws from the study in the intervention group.

Baseline data for continuous variables will be summarized as mean and standard deviations, whereas categorical variables will be summarized as frequencies and percentages.

For the main hypothesis, using the total score on the self-esteem scale at T3, we will calculate summary statistics for each group and compute the 95% confidence interval (CI) for the mean. Furthermore, we will fit an MMRM, including sex, intervention, time point, and interaction between intervention and time point as a fixed effect, and group as a random effect. We will calculate the group differences in least squares means, their standard errors, 95% confidence intervals, and p-values at T3. The variance-covariance structure of the error terms in the MMRM will be conducted in the following order: unstructured, compound symmetry, and auto-regression. The estimation results based on the first successful convergence of the specified structure will be adopted. MMRM estimation will be conducted using the restricted maximum likelihood method. Similarly, we will undertake an analysis targeting the Per-Protocol Set as a sensitivity analysis.

For the secondary hypothesis, the change over time in the self-esteem scale and summary statistics will be calculated for T1 and T2 in the same manner as above, and the same model will be used to calculate the group differences in least squares means, their standard errors, 95% confidence intervals, and p-values at T1 and T2. The other hypothesis, the HHI and SCS, will be analyzed in the same manner as the self-esteem scale.

All statistical analyses will be performed using SAS software, version 9.4 (SAS Institute).

Ethics and dissemination

Documents on the ethical issues of the study have been developed, including the study protocol, voluntariness of participation, privacy policy, data management, participants’ safety, and the absence of conflicts of interest. The study protocol was evaluated and approved by the Research Ethics Committee of the Shonan University of Medical Sciences on July 18, 2023 (No. 23 − 014).

M Kusaka, who has a nurse-license, will be carefully monitoring the health conditions of the participants via e-mail. If a participant has an unscheduled doctor's visit or a medical condition that worsens, M Kusaka will speak with the participant over the phone and make a preliminary assessment regarding need for further assessment and/or treatment.

After completing this study, we will publish the results in an international peer-reviewed medical or nursing journal and present the results at national and international conferences. Information on publication will be announced on the AIRIKI homepage according to the journal’s publication policies.

In Maslow’s hierarchy of needs, every human needs love and belonging, which include friendships, family, and intimate partner.¹⁴ People with mental disorders may find it difficult to initiate and develop intimate relationships with others because of their mental symptoms, adverse effects of medicine, or lack of communication skills.

The AIRIKI program is a group work program for thinking about and discussing intimate relationships and marriage among people with mental illness with their peers and with professionals. In this study, we developed the videoconferencing version of AIRIKI for people with mental disorders to reach participants from different regions of Japan. Other merits of videoconferencing include COVID-19 and flu infection prevention, cost-effectiveness (saving venue and transportation expenses), and participation from home which may relieve the anxiety of participants. The program offers different components that enable talking about partnerships, communication skills (both verbal and non-verbal) with their dating partners and imagining married life. In this study, the participants are limited to un-married individuals. The problem of partnerships may differ between unmarried and married individuals. Married people generally have a fixed and stable relationship with their partner due to living together which is not the situation with unmarried people. Therefore, this study focuses on unmarried people who may have trouble initiating and developing new, intimate relationships with their dating partners.

Programs focusing on intimate relationships, and marriage among people with mental disorders are limited. This study’s results may suggest the potential use of videoconferencing programs that focus on intimate relationships and marriage among people with mental disorders. Additionally, if our hypotheses are confirmed, the AIRIKI videoconferencing program may help improve self-esteem, hope, and self-confidence in communication with potential partners for a successful marriage. In summary, this study may significantly contribute to promoting the use of videoconferencing group work programs for intimate relationships and marriage among people with mental disorders.

CI confidence interval

FAS Full Analysis Set

HHI Herth Hope Index

ITT Intention-to-treat

MMRM Mixed-effect Model for Repeated Measures

PPS Per Protocol Set

RCT randomized controlled trial

RSES Rosenberg Self-esteem Scale.

SCS Self-Confidence in Communication Scale

SNS Social Network Service

USD United States Dollars

Ethics approval and consent to participate

This study protocol was approved by the Research Ethics Committee of the Shonan University of Medical Sciences on July 18, 2023 (Approval no. 23-014). Written informed consent will be obtained from all participants.

Consent for publication

Not applicable

Availability of data and materials

Not applicable

Competing interests

The authors declare that they have no competing interests.

Funding

This study is supported by JSPS KAKENHI Grant Number 23H03226 and research funding of Shonan University of Medical Sciences.

Authors’ contribution

Conceptualizations: Masako Kageyama, Keiko Yokoyama, Kayo Ichihashi

Design, methodology, writing, review, and editing: Momoko Kusaka, Masako Kageyama, Keiko Yokoyama, Kayo Ichihashi, Ryota Hashimoto, Kazutaka Nishio, Phyllis Solomon

Supervision: Masako Kageyama, Phyllis Solomon

All authors have read and approved the final manuscript.

Acknowledgement

We would like to thank all facilitators of the AIRIKI program for providing us with useful advice for the creation of this videoconferencing program.

Authors’ information

Momoko Kusaka: Department of Nursing, Shonan University of Medical Sciences, Yokohama, Japan

Masako Kageyama: Institute of Advanced Co-Creation Studies, Osaka University, Osaka, Japan

Keiko Yokoyama: Department of Nursing, Faculty of Nursing, Yokohama Soei University, Yokohama, Japan

Kayo Ichihashi: Department of Neuropsychiatry, University of Tokyo Hospital, Tokyo, Japan

Ryota Hashimoto: Department of Pathology of Mental Diseases, National Institute of Mental Health, National Center of Neurology and Psychiatry, Tokyo, Japan

Kazutaka Nishio: Medical Center for Translational Research, Osaka University Hospital, Osaka, Japan

Phyllis Solomon: School of Social Policy & Practice, University of Pennsylvania Philadelphia, USA

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Table 1. Components of the AIRIKI online program

				Structure
				The program focuses on intimate relationships
				Small group of less than 9 people
				Groups are led by peer facilitators and healthcare professionals
				Sharing own thoughts and experiences about loving people
Modules	min	Lesson	Purposes	Contents
Day 1
Warming-up	20		Ice break	Self-introduction, motivation for participation, favorite type of person, mood of participants
Chapter 1 The love that you think about	8	Introduction	Introduction of the program and sharing the rules	Introduction of AIRIKI program Basic rules of the program
	7	What is love for you?	Sharing thoughts about loving people	Introduction of theories and quotations about love. Sharing their thoughts and experiences. Contents include not only loving their partner but also being loved by parents or friends.
	10	What is the difference between love and romance?
	5	Whom do you love?
	20	Important people and events for your recovery	Sharing the experience of being loved by someone	Participants introduce how people and events have affected their process of recovery.
	10	Reflection	Summarize own thoughts	Participants share their awareness and impressions about Chapter 1.
Chapter 2 Understand your partner	15	What do you need to do for love?	Clarify what is important to love others	The ability of love includes comprehension, caring, respect, and responsibility. Personal boundaries are briefly described.
	7	Basic communication skills	Learn communication skills	Learning about basic communication skills such as listening carefully. Participants share what they are careful about their communication.
	28	Skill training in inviting date	Learn communication skills	As a communication exercise, participants simulate in a role play with each other where they invite and are invited for the first date.
	5	Reflection	Summarize own thoughts	Participants share their awareness and impressions about role play.
	25	Reflection and positive feedback	Reflect on what they were impressed with and share their thoughts	Participants present what impressed on Day 1 program. All participants and facilitators share their thoughts and offer messages of support to each other.
Day 2
Chapter 3 Meeting and dating	7	Warming-up	Ice break	Beginning of second day; Sharing their mood and basic rules of the program.
	10	How do we find a partner?	Aware of own thoughts regarding meeting partner	Participants share what they think important in choosing and finding a partner.
	13	Dating manners	Caring about a partner	Participants share what dating manners they know.
	40	Conversation and skill training in confiding their illness	Practice ways to confide their illness to dating partner	Important to know how to confide their illness to dating partner Participants practice in their own way.
	10	Reflection	Summarize own thoughts	Participants share their insights and impressions.
Chapter 4 Maintaining a long-term relationship	8	Factors to be careful of in an intimate relationship	Reduce risks in romantic relationships	Mental health condition impacted by loving people, sexually transmitted diseases, unexpected pregnancies, and intimate partner violence are briefly explained.
	12	Marriage	Think of whether to get married and coping with problems in marriage	Changes associated with marriage (e.g., sharing household finances, rhythm of daily living) are explained. Side effects of medications on sexual difficulties and child care are also explained.
	40	Reflection and positive feedback	Reflect on what impressed them and share their thoughts of program.	Participants present what impressed them about program and their own future plans. All participants and facilitators share their thoughts and send messages of support to each other.
	10	Overall comments	Program completion	Participants share their overall thoughts of two-day program.

Table 2. The contents of questionnaire

	Demographic variables	Outcomes
T1 (baseline assessment)	✓	✓
T2 (following assessment 1)		✓
T3 (following assessment 2)		✓

No competing interests reported.

Effects of an online program about intimate and romantic relationships for people with mental disorders (AIRIKI): a study protocol for a randomized controlled trial

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