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10.1136/bmjopen-2023-079429
bmjopen-2023-079429
Protocol
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Feasibility and potential effects of a dyadic coping intervention for patients with spinal cord injury and their spouses: a study protocol for a pilot randomised controlled trial
Feng Linsheng 1434242948@qq.com
12
Wang Ting 2062086886@qq.com
2
Cai Yujing 826858723@qq.com
2
Dai Qing ayhldaiq@163.com
1
Ding Peipei 3089298519@qq.com
2
http://orcid.org/0009-0006-0228-685X
Li Lunlan 15056029341@163.com
32
1 Department of Spine Surgery, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China
2 School of Nursing, Anhui Medical University, Hefei, Anhui, China
3 Human Resources Department, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

None declared.

Professor; 15056029341@163.com
2024
24 8 2024
14 8 e07942931 8 2023
30 7 2024
Copyright © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
2024
https://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

Abstract

Introduction

It remains difficult for patients with spinal cord injury (SCI) to fully recover their sensory and motor functions; thus, they must rely on the assistance of caregivers to complete activities of daily living. This leads to psychological distress and decreased quality of life in patients and caregivers. Interventions for dyadic coping are a promising option. However, no studies have examined the effects of dyadic coping interventions on patients with SCI and their spouses. Therefore, our team constructed a dyadic coping intervention programme for couples with SCI.

Method and analysis

This two-arm, parallel-design, pilot randomised controlled trial will recruit 72 couples with SCI from two tertiary hospitals in Hefei, China. Couples will be randomly allocated to two arms. Couples randomly assigned to the intervention group will receive the usual care and the dyadic coping intervention. Couples randomly assigned to the control group will receive usual care only. The primary outcomes will be the feasibility and acceptability of the dyadic coping intervention for couples with SCI. Secondary outcomes will be quality of life, psychological distress, caregiver burden, marital satisfaction and dyadic coping. Outcomes will be collected at three time points: baseline (T0), post-intervention (T1) and after a follow-up period of 8 weeks (T2).

Ethics and dissemination

This study has been approved by the Research Ethics Committee of Anhui Medical University (84240008). The results will be published in a peer-reviewed journal.

Trial registration number

ChiCTR2300074556.

Spine
Nursing Care
Psychosocial Intervention
Randomized Controlled Trial
Scientific research and cultivation project of School of Nursing, Anhui Medical University hlqm12023065 Natural Science Research Program for Universities in Anhui Province KJ2020ZD18
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pmcStrengths and limitations of this study

This dyadic coping intervention programme was developed specifically for couples with spinal cord injury.

In the development of the programme, patient and public involvement were fully considered, and experts were consulted using the Delphi method.

The intervention covers the perioperative and rehabilitation period, meeting the needs of patients and spouses at different times.

The small sample size cannot provide definitive conclusions about the effects of dyadic coping interventions.

Blinding of participants and interveners is impossible due to the nature of the intervention.

Introduction

According to the 2016 Global Burden of Disease Study, the global prevalence of spinal cord injury (SCI) is 20.6 million, with an annual incidence of 900 000, and both the prevalence and incidence are on the rise.1 In China, the incidence of SCI is approximately 23.7 per million.2 SCI is a devastating neurological and pathological condition that often leads to motor, sensory and autonomic dysfunction below the site of injury.3 Currently, the possibility of patients completely recovering sensory and motor functions caused by SCI is limited because mature nerves in the central nervous system rarely recover from damage.4 5 Therefore, patients with severe neurological injury will present with permanent disability, accompanied by multiple serious complications, such as neurogenic bladder, spasms, pressure injury and deep vein thromboses.6 For these patients with motor dysfunction or complications, family caregivers play an important role in daily living and functional recovery.

The functional impairment of individuals caused by SCI not only diminishes patients’ quality of life and lead to psychological distress but also has a negative impact on their family members,79 particularly on their spouses. The responsibility of caring for individuals with SCI falls primarily on their spouses.10 Long-term commitment to caring for patients with SCI places a heavy care burden on spouses and may affect marital satisfaction between patient couples.11

When dealing with the dyadic stress caused by a disease, couples may choose to cope together, which is referred to as dyadic coping (DC).12 According to the systemic-transactional model, DC can be divided into (1) positive DC, including open communication, supportive DC, delegated DC and common DC; and (2) negative DC including providing ambivalent support, uninvolved strategies, hostile communication and protective buffering.13 Several studies have shown that positive DC in couples means higher levels of quality of life and marital satisfaction, as well as lower levels of psychological distress.1416 However, Jeyathevan et al17 found that patients with SCI and their spouses were more likely to adopt negative DC, which is similar to our previous research results.18 Therefore, it is necessary to take measures to reduce the number of negative DC strategies and promote the number of positive DC strategies in patients with SCI and their spouses.

Emerging evidence has shown that interventions based on DC for couples coping with diseases are effective.1922 However, no studies have examined the effects of DC interventions in couples with SCI. Therefore, we constructed a DC intervention programme for couples with SCI. The programme consists of six sessions, including aspects such as DC skills, disease-coping knowledge, couple communication skills and psychological education, covering the entire patient process from admission to rehabilitation. This study protocol aims to evaluate the feasibility, acceptability and preliminary effects of a DC intervention programme on the quality of life, psychological distress, marital satisfaction and caregiving burden of individuals with SCI and their spouses.

Study objective

To demonstrate the feasibility and acceptability of the intervention through recruitment, retention, drop-out, adherence and satisfaction ratings.

To investigate the effects of the intervention on a range of outcome measures.

To amend the intervention based on the results of this pilot randomised controlled trial (RCT).

To use data from this pilot RCT for sample size calculation for future large RCTs.

Methods and analysis

Design

This will be a two-arm, parallel-design, pilot RCT. We plan to start enrolling the first patient in March 2024 and expect to complete the intervention in January 2025. Participants who meet the eligibility criteria and provide consent will be randomly assigned to one of two groups: a DC intervention group or a control group. The two groups will be compared at baseline (T0), post-intervention (T1) and at 8 weeks follow-up (T2). After the baseline assessment, participants will receive a DC intervention for approximately 4 weeks, with 8 weeks of follow-up. The study design and process are illustrated in figure 1.

Figure 1 The study design and process. SCI, spinal cord injury.

Eligibility

Couples with SCI who meet the inclusion criteria will be invited to participate in this study. The inclusion criteria are as follows: (1) married couples, aged ≥18 years old; (2) one of the couples has been diagnosed with new SCI according to the International Standard for the Neurological Classification of Spinal Cord Injury, with American Spinal Injury Association classification grades A, B, C or D; (3) the other spouse has lived with the patient for more than 1 year before the injury and is the main caregiver of the patient; and (4) both couples have been informed about and agreed to participate in this study.

Any couples who meet any of the following criteria will be excluded from the study: (1) one or both spouses have a history of psychiatric conditions related to hallucinations or delusions, or severe cognitive impairment, as its symptoms could affect their ability to participate in the programme; (2) one or both spouses have other serious physical diseases, such as heart failure or brain injury; (3) individuals with non-traumatic injury; and (4) individuals who are severely injured or have unstable vital signs, such as being unable to breathe on their own.

Recruitment

Couples with SCI will be recruited from the spine surgery departments of two tertiary hospitals in Hefei City, Anhui Province, China. The study staff will work closely with nurses from the two hospitals, who will inform the researchers when couples with SCI meet the eligibility criteria. First, the researchers will first inform couples with SCI about the purpose and methods of the study and answer their questions. Next, if they agree to participate, they will be requested to sign an informed consent form, which is available in the online supplemental material.

Randomisation

Eligible couples with SCI will be randomly assigned to an intervention or control group by a statistician responsible only for randomisation. The statistician will employ the minimisation method to ensure a balance in the level and severity of the injury as well as gender between the two patient groups at baseline. The allocation sequence will be placed in opaque, sealed envelopes to maintain concealment. Owing to the nature of the intervention, it will be impossible to blind the participants and the interveners. However, the outcome assessors and data analysts will be blinded to the group allocation.

Intervention

Intervention group

The intervention group will receive the DC intervention and standard care. This intervention was developed by a research team comprising a spine surgeon, a rehabilitation physician experienced in SCI rehabilitation, clinical nurses and master’s-level researchers. First, semi-structured interviews were conducted with 12 couples with SCI, revealing a tendency for negative DC strategies.18 Next, a review of relevant literature informed the initial formulation of the DC intervention programme. Structured interviews involving 24 couples with SCI and 30 healthcare professionals were then conducted to optimise the programme based on the interview results. This process involved determining the number of interventions, the themes, purposes and content of each intervention. Finally, 17 experts in SCI treatment, rehabilitation, nursing and psychology were invited to participate in two rounds of the Delphi expert consultation survey, resulting in the finalisation of the DC intervention programme based on their collective insights.

The DC intervention was developed based on the systemic-transactional model, which posits an interdependent relationship between couples, when facing stress, the individual-centred stress coping model is transformed into a systemic interaction model. Disease stress not only affects the patient but also their spouse.23 We plan to administer the intervention to couples with SCI as a dyad and assess their coping styles. The content of each meeting is formulated with the goal of promoting positive DC in couples. The DC intervention, comprising six sessions spanning approximately 4 weeks, will be administered by clinical nurses who have been trained in it. Sessions 1–4 will be conducted face-to-face at the hospital. Sessions 5 and 6 will be conducted through face-to-face video calls (such as WeChat video calls). Patients with SCI and their spouses will be asked to attend each intervention session together. Each session will last approximately 30 min. These sessions will be delivered at different times from admission to rehabilitation. The specific intervention contents and times are presented in table 1.

Table 1 Overview of the dyadic coping intervention programme

Session	Session theme	Objectives	Contents	
1 (day of admission or the following day)	Building trust and changing perceptions	Establish a trusting relationship with SCI couples, understand their basic situations and psychological state and help them establish the concept of coping with the disease together.	Researcher and the couples introduce each other.

Become familiarised with the couples’ social background, the cause of injury, self-care ability and caring ability, etc, through listening, empathy and understanding, to establish a trusting relationship with the couples.

Assess the psychological state and coping style of both the patient and the couple in the face of stressful events related to spinal cord injury.

Common coping: change the perspective of the couples on the disease from being a ‘patient’s disease’ to ‘our disease’ when treating spinal cord injury.

Shared decision-making: allow patients and their spouses to make medical and care decisions together.

	
2 (3 days after injury)	Developing a preliminary understanding of dyadic coping	Help SCI couples preliminarily understand the concepts of dyad coping, master disease-related knowledge.	Educate the couples on dyadic coping, such as the definition and types of dyadic coping and the benefits of dyadic coping intervention. Introduce the subsequent intervention process.

Reduce uncertainty concerning the disease: the researcher cooperates with the doctors to provide couples with SCI-related disease guidance, such as preoperative preparation, prevention of complications.

	
3 (1 week after injury	Applying dyadic coping skills	Help SCI couples master dyadic coping skills.	Disease coping skills: usual nursing skills (turning over, canal nursing, etc), early rehabilitation exercise methods (respiratory function exercise, active and passive movement of limbs in bed, etc).

Dyadic coping skills: promote positive coping (common coping, supportive coping, delegated coping, open communication), identify negative coping and transform this into positive coping.

Empathy experience: encourage the couples to empathise and support each other and reduce negative emotions.

Scenario simulation: guide the spouse to simulate the patient’s current physical condition, experience the unpleasant emotion brought on by the disease for the patient and help the patient realise the contribution of the spouse and understand their hard work.

Stress coping techniques: progressive muscle relaxation, music therapy, etc.

Encourage the couples to recall happy times together, such as love, marriage, travel, etc.

The researchers assist the couples to jointly formulate reliable short-term goals (eg, that patients and spouses master basic disease coping skills through mutual cooperation) and encourage the couples to achieve them together.

	
4 (2 weeks after injury)	Applying dyadic communication skills	Help SCI couples master dyadic communication skills.	Teach communication skills to the couples, introduce cases of effective and ineffective communication and reduce the disease-related pressure caused by miscommunication between the couples.

Self-disclosure: encourage patients and spouses to share their true thoughts and feelings (the 3-Phase Method).

The couples reflect on their problems in communication and identify the reasons for negative emotions.

Homework: guide the patient and spouse to express their gratitude to each other, such as writing a thank-you note to each other, recording a short video or creating a small surprise for each other (if the patient cannot write on their own, the researcher can write it for them).

	
5 (3 weeks after injury)	Strengthening dyadic coping skills	Help SCI couples build confidence in rehabilitation and consolidate dyadic coping skills.	Share cases of patients who actively cope with the disease and who have achieved good recovery effects with the patient couple; give them more encouragement and increase their confidence in recovery.

Couples who are recovering in the hospital will be given routine rehabilitation exercise guidance, and couples who are recovering at home will be given home rehabilitation guidance. Correct their training misunderstandings. Encourage spouses to participate in the process of rehabilitation and engage in rehabilitation exercises with patients.

Guidance on disease symptom management knowledge (neurogenic bladder, neurogenic bowel, neuropathic pain, etc). Guide the couples to encourage each other and learn relevant knowledge together.

Review previously learnt dyadic coping skills and dyadic communication skills.

Read the thank-you note (or watch the video) written in the last session and guide the listener on providing feedback concerning their real inner thoughts after listening or watching.

	
6 (4 weeks after injury)	Looking to the future	Help SCI couples perceive the benefits of dyadic coping and look forward to the future.	Review the entire intervention process, guide the couples to express their feelings and gains through the intervention and the changes in their understanding of intimate relationships through face-to-face communication.

Guide patient and spouse separately to share plans about coping with the disease.

Guide couples to share their future life expectations and action plans, and jointly set reasonable medium and long-term goals (such as being able to partly take care of themselves or master the method of self-intermittent urinary catheterisation).

	
SCIspinal cord injury

Control group

The control group will receive standard care provided by clinical nurses, including perioperative care, rehabilitation exercise guidance and routine follow-up. The control group will not receive any guidance or intervention related to DC during the study.

Outcome measures

The primary outcomes will include the feasibility of recruitment and follow-up processes as well as the feasibility and acceptability of the DC intervention. The details of the primary outcome measures are summarised in table 2.

Table 2 Details of primary outcome measures

Outcomes	Measure	Description	
Feasibility	Recruitment rate	Proportion of participants who participate in this study in relation to the number of participants who meet the inclusion and exclusion criteria.	
Retention rate	Proportion of participants who complete the whole study in relation to the number of participants who participate in this study.	
Drop-out rate	Percentage of participants who drop out during intervention and follow-up.	
Adherence rate of intervention	Percentage of the number of sessions completed by participants in the total number of sessions.	
Acceptability	Participants’ satisfaction	The Client Satisfaction Questionnaire, which consists of 8 items, will be used to evaluate participants’ satisfaction.37 The scale has shown good reliability in the SCI population (Cronbach’s α=0.94).38	
Reasons for dropping out	Participants who withdraw from the study will be asked their reasons for dropping out.	
SCIspinal cord injury

Secondary outcomes include quality of life, psychological distress, marital satisfaction, DC level of SCI couples and caregiving burden of spouses.

Quality of life

Quality of life will be measured using the Chinese version of the WHO Quality of Life Brief Scale (WHOQOL-BREF).24 It includes 26 items with four dimensions: physical, psychological, social relationships and environment, and two single items that evaluate general quality of life and health. The total WHOQOL-BREF score ranges from 0 to 100, with a higher score indicating better quality of life.25 The scale has demonstrated good reliability in Chinese patients with SCI (Cronbach’s α=0.93).26

Psychological distress

The Hospital Anxiety and Depression Scale (HADS) will be used to assess the psychological distress of the participants.27 It includes two dimensions, anxiety and depression, with a total of 14 items. The Chinese version of the HADS has been verified for patients with SCI.28 29

Caregiving burden

The caregiving burden of spousal caregivers will be evaluated using the Zarit Caregiver Burden Inventory (ZBI),30 which includes two dimensions with a total of 22 items that are evaluated by a 5-point Likert scale. The total score of ZBI ranges from 0 to 88 points. The burden on spouses is classified as mild (0–40 points), moderate (41–60 points) or severe (61–80 points). The Chinese version of the ZBI has demonstrated good reliability (Cronbach’s α=0.87).31

Marital satisfaction

The Locke-Wallace Marital Adjustment Test (LWMAT) will be used to evaluate participants’ marital satisfaction.32 The scale consists of four dimensions with a total of 15 items, and the total score ranges from 2 to 158 points, with a higher score indicating better marital adjustment. The Chinese version of the LWMAT has shown good internal consistency and validity.33

DC level

The 35-item Dyadic Coping Inventory (DCI), developed by Bodenmann et al, will be used to assess the DC level of couples with SCI in this study.34 The scale consists of five dimensions assessed using a 5-point Likert scale. The Chinese version of the DCI has demonstrated good reliability (Cronbach’s α=0.51–0.80).35

Sample size calculation

Given that this is a preliminary study, the primary purpose is to assess the feasibility and acceptability of recruitment, protocol procedures, intervention and data collection. Thus, 30 couples will be recruited in each group, which is considered reasonable and sufficient for the estimation of between-group comparisons and effect sizes in a pilot study.36 Considering a potential attrition rate of 20%, the sample size will be 36 per group.

Data collection and management

Data will be collected at baseline, post-intervention and at 8 weeks post-intervention by two independent outcome assessors. Outcomes for patients will be collected by one assessor, while outcomes for spouses will be collected by the other assessor. At baseline, in addition to the following outcome indicators, general information concerning the participants, such as age, sex, education level, SCI segment and SCI classification, will also be collected. The participants data will be stored in password-protected files on a designated computer. All data will be destroyed after the research results are published. The schedule of enrolment, interventions and assessments are presented in table 3.

Table 3 The schedule of enrolment, interventions and assessments

Study period	Enrolment	Baseline(T0)	Post-intervention(T1)	8 weeks follow-up(T2)	
ENROLMENT:					
 Eligibility screen	X				
 Informed consent	X				
 Allocation	X				
INTERVENTIONS:					
 Intervention group					
 Control group					
ASSESSMENTS:					
 Demographic		X			
 Feasibility		X	X	X	
 Acceptability			X	X	
 WHOQOL-BREF		X	X	X	
 HADS		X	X	X	
 LWMAT		X	X	X	
 ZBI		X	X	X	
 DCI		X	X	X	
DCI, Dyadic Coping InventoryHADS, Hospital Anxiety and Depression Scale; LWMAT, Locke-Wallace Marital Adjustment Test; WHOQOL-BREF, WHO Quality of Life Brief Scale; ZBI, Zarit Caregiver Burden Inventory

Statistical analyses

Data analyses will be performed using IBM SPSS V.23.0. All data will be entered into a computer by two researchers using EpiData V.3.1. Descriptive statistics will be used for the feasibility outcomes and acceptability outcomes. For the efficacy outcomes, an intention-to-treat analysis will be performed. The Shapiro-Wilk test will be used to test whether the continuous variables conform to a normal distribution. Normally distributed data will be reported as means and SD, whereas non-normally distributed data will be reported as median and IQR. Categorical variables will be described by frequency. Continuous data will be analysed using the independent t-test, or Mann-Whitney U test. Categorical data will be analysed using χ2 tests for between-group comparisons. Statistical significance will be set at p<0.05 using a two-tailed test.

Patient and public involvement

Before constructing the programme, we invited couples with SCI to participate in qualitative interviews to understand their experiences with DC with SCI. During the development of the programme, we also conducted structured interviews involving 24 couples with SCI and 30 healthcare professionals for optimisation.

In the process of programme construction, couples with SCI, spine surgeons, rehabilitation physicians, nurses and psychologists have provided valuable suggestions for the programme, and we have modified the programme accordingly.

Ethics and dissemination

This study protocol has been approved by the Ethics Committee of Anhui Medical University (84240008). All participants will be required to sign a written informed consent form after being informed of the study. Participants will have the right to drop out at any time. Participants’ information collected in this study will be securely stored in a password-protected file accessible only to specified members of the research team. The findings of this RCT will be published in a peer-reviewed clinical journal for widespread publication.

Discussion

This is the first RCT involving a DC intervention in couples with SCI. Our DC intervention will commence in the day of admission and continue through hospitalisation or home rehabilitation, which will provide guidance to couples with SCI throughout the process. This study may provide a new method for couples with SCI to positively cope with the disease together.

This study has several strengths. First, this programme is specifically tailored to the disease characteristics of SCI, and individualised intervention content will be provided according to the severity of injury in each patient. In addition, we consulted spinal surgeons, rehabilitation physicians, psychologists and nursing specialists during the programme-development phase and modified the intervention using the Delphi method, which helped ensure the applicability and scientific validity of the programme. Importantly, the findings of this preliminary RCT will provide useful information and experience for conducting future high-quality full-scale clinical trials.

This study has some limitations. Because this is a pilot study with a small sample size, the results cannot be used to draw definitive conclusions about the effects of the DC intervention. In addition, recruitment can be challenging, because the participants recruited in this study need to be dyads consisting of patients and spouses. Moreover, because the follow-up period is only 8 weeks, we will not be able to evaluate the long-term ongoing effects of the DC intervention programme. Finally, the participants and interveners cannot be blinded to the interventions because of the nature of the intervention.

In conclusion, this pilot RCT will assess the feasibility, acceptability and preliminary effects of a DC intervention programme. The findings of this study will further our understanding of this programme and can be used to inform the sample size calculation and intervention programme optimisation of future large-sample RCTs.

supplementary material

10.1136/bmjopen-2023-079429 online supplemental file 1

Review Process File
24 8 2024

Funding: This work was supported by the Natural Science Research Program for Universities in Anhui Province (grant number KJ2020ZD18) and the scientific research and cultivation project of the School of Nursing, Anhui Medical University (grant number hlqm12023065).

Prepub: Prepublication history and additional supplemental material for this paper are available online. To view these files, please visit the journal online (https://doi.org/10.1136/bmjopen-2023-079429).

Provenance and peer review: Not commissioned; externally peer reviewed.

Patient consent for publication: Not applicable.

Patient and public involvement: Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
==== Refs
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