Continuity therapy for couples living with brain injury
| ISRCTN | ISRCTN93611293 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93611293 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 320276 |
| Protocol serial number | IRAS 320276, CPMS 55029 |
| Sponsor | University of Birmingham |
| Funder | National Institute for Health and Care Research |
- Submission date
- 02/06/2023
- Registration date
- 06/06/2023
- Last edited
- 06/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Brain injuries such as stroke and head injuries can put a severe strain on marriages/partnerships. Our previous research suggests that one contributing factor is a a sense of ‘discontinuity’. This refers to the non-injured partner that the person with the injury is now very different compared to who s/he was before the injury (“He's not the person I married") and that their relationship is also radically changed (“I feel like her carer, not her husband”). The injured partner can also feel very different and evidence suggests that this can undermine the person's self-esteem and psychological wellbeing. To address these issues, we have been developing a psychological therapy for couples focused on increasing their sense of continuity between past and present. In a published report, we described using this therapy with a couple. Following therapy, the couple showed promising improvements in their relationship and wellbeing.
The study aims:
•To expand and develop this initial version of the therapy, producing detailed guidelines for its use
•To give couples living with brain injury the opportunity to contribute to this development
•To collect information about its potential effectiveness so that we can decide whether the therapy merits being properly evaluated in a future controlled trial.
Who can participate?
Any couples in which one partner has experienced a brain injury within the last 5 years (but not within the last 12 months); and who feel that the brain injury has had a bad effect on their relationship.
What does the study involve?
Participants will take part in approximately 10 therapy sessions with a clinical psychologist. They will also complete questionnaires before the therapy starts and after it has finished. The questionnaires are about psychological wellbeing and the quality of the relationship. Participants will also take part in an interview after the end of the therapy about their experience of the therapy.
What are the possible benefits and risks of participating?
Participants may experience an improvement in their relationship and psychological wellbeing. In terms of risk, it may be upsetting at times to talk about what has happened in your life and about your relationship and there is a risk that this will make things worse for participants' wellbeing and relationship.
Where is the study run from?
The study is a collaboration between the University of Birmingham and Birmingham Community Healthcare NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
February 2023 to March 2025
Who is funding the study?
National Institute for Health and Care Research (UK)
Who is the main contact?
Dr Gerard Riley, g.a.riley@bham.ac.uk
Contact information
Principal investigator
School of Psychology
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
 ORCID ID |
0000-0002-1167-8023 |
|---|---|
| Phone | +44 7880 673385 |
| g.a.riley@bham.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre focused on the initial development and uncontrolled evaluation of a psychological therapy |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Continuity Therapy for couples living with brain injury: A tier 3 study focused on development of an intervention |
| Study objectives | The study aims to develop an complete some initial uncontrolled evaluation of a psychological therapy to improve the relationship of couples living with brain injury |
| Ethics approval(s) | Approved 22/02/2023, South East Scotland Research Ethics Committee 02 (2nd Floor, Waverley Gate, 2-4 Waterloo Place, Edinburgh. EH1 3EG, UK; +44 131 536 9000, ruth.fraser4@nhslothian.scot.nhs.uk) ref: 23/SS/0012 |
| Health condition(s) or problem(s) studied | Acquired brain injuries such as stroke and traumatic brain injury |
| Intervention | Once enrolled onto the study, participants will complete the baseline questionnaires. They will then receive 10 sessions of psychological therapy. Each session will last about 1 hour. The first 5 sessions will take place weekly, but will be fortnightly thereafter. Once the therapy is completed, participants will complete the post-intervention questionnaires and take part in an interview about their experience of the therapy. This post-intervention meeting will last about 1.5 hours. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
For the partner with a brain injury: |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 31/03/2025 |
Eligibility
| Participant type(s) | Patient, Carer |
|---|---|
| Age group | Adult |
| Lower age limit | 21 Years |
| Sex | All |
| Target sample size at registration | 20 |
| Total final enrolment | 32 |
| Key inclusion criteria | 1. One member of the couple must have experienced an acquired brain injury 2. One or both partners report some dissatisfaction with their current relationship. 3. Couples must be living together at the time of participation. 4. Couples must have lived together for at least 5 years before the injury. 5. The injury must have occurred at least 1 year previously. 6. The injury must have occurred no more than 5 years previously. 7. Both participants are over the age of 21. There is no upper age limit. |
| Key exclusion criteria | 1. People cannot take part if they are not capable of giving informed consent or taking a meaningful part in verbal therapy conducted in English. 2. People who have serious additional mental or physical health conditions that may have a serious impact on their participation. 3. There are significant concerns about the psychological wellbeing of one or both members of the couple. 4. There are significant concerns that the couple are about to split up. |
| Date of first enrolment | 01/04/2023 |
| Date of final enrolment | 30/11/2024 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Alcester Road
Moseley
Birmingham
B13 8JL
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in publicly available repository, Stored in non-publicly available repository |
| IPD sharing plan | Anonymised pre and post-therapy questionnaires will be stored in a publicly available repository at the Mendeley data store https://data.mendeley.com/ Material containing potentially identifying information will be stored in a non-publicly available Research Data Store at the University of Birmingham. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 6 | 21/11/2023 | 12/02/2024 | No | No |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN93611293 Protocol V6 21.11.2023.pdf
- Protocol file
Editorial Notes
06/03/2025: The total final enrolment was added.
14/11/2024: Study website added.
12/02/2024: Uploaded protocol (not peer-reviewed) as an additional file.
05/06/2023: Trial's existence confirmed by NHS Lothian
