Marital RelationshipPhase 3NCT01405014
Outcome Study of Hold Me Tight Program With Acquired Brian Injury (ABI) Populations
A Phase 3 study testing Hold Me Tight in people with Marital Relationship, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
The objectives of this research pilot project are to assess the efficacy of the Hold Me Tight Relationship Enhancement Program with couples where at least one partner has an acquired brain injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Marital Relationship
- What is being tested?
- Hold Me Tight
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2012to Jul 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must:
- be over the age of 18;
- be in a relationship at least 24 months and must be living together
- be at least 12 months post brain injury event
- be able to read and understand English, follow verbal instructions and provide verbal answers to questions;
- be able to follow-up as per Hold Me Tight program protocol;
- be willing to take part in the study, including completing all questionnaires before and after the intervention;
- are competent to give informed consent as determined by the Investigators
Who cannot join
- Participants must NOT:
- suffer from severe aphasia or dementia as determined by health chart;
- have active psychiatric illness;
- have other neurological condition(s);
- be couples where both partners have sustained a brain injury;
- have a high level of relationship distress better served by seeking individual couple therapy as indicated by a DAS score of 70 or less for either member of a couple
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of the Hold Me Tight Relationship Enhancement Program With Couples Where One Partner Has an Acquired Brian Injury
The objectives of this research pilot project are to assess the efficacy of the Hold Me Tight Relationship Enhancement Program with couples where at least one partner has an acquired brain injury.
Read the detailed description
Families, and spouses in particular, have been shown to play important roles in all aspects of health care, especially when family members are recovering from the trauma of sudden illness or an accident such as a brain injury. A limited body of evidence suggests couple therapy provides patients and their spouses with the opportunity to explore the experience of trauma as it relates to becoming physically disabled within the context of intimate relationships. Being in close contact and emotionally connected to a person who has experienced trauma becomes a chronic stressor that can cause family members to experience trauma symptoms themselves. This phenomenon is termed secondary traumatic stress. For example, children can mimic a parent's trauma responses through identification with the parent or direct training. This is a specific type of secondary traumatisation transmitted intergenerationally.
The research about individuals who have a traumatic brain injury (TBI) and the impact of the injury on family functioning has outlined a number of challenges including: psychological distress, particularly anxiety and depression, among caregivers; disruptions in family functioning; and the impact on relationships including caregiver burden. Furthermore, among the most difficult conditions for couples to deal with are those involving cognitive impairment.
Hold Me Tight is a couples enrichment program that is based on the Emotionally Focused Therapy (EFT) approach to working with couples. EFT is an empirically supported treatment that arose out of emotion theory and attachment theory. It views emotions as centrally important in the experience of self, in both adaptive and maladaptive functioning, and in therapeutic change. From the EFT perspective change occurs by means of awareness, regulation, reflection, and transformation of emotion taking place within the context of an empathetically attuned relationship. There is significant research on this approach and it has been found that 70-75% of couples move from distress to recovery and that the gains are sustained for months to years following the end of treatment. As such, EFT is an evidence based treatment protocol.
- Conditions
- Marital Relationship
- Being tested
- Hold Me Tight
- Keywords
- Hold Me Tight, Emotionally Focused Therapy, Relationship enhancement, Couples counseling, Marital therapy, Acquired brain injury, Traumatic brain injury, Stroke
- Medical subject headings
- Brain Injuries, Brain Injuries, Traumatic, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hold Me TightBehavioural
Relationship enhancement group
| Study group | Role | What they receive |
|---|---|---|
| Relationship enhancement group | Experimental | One group, all involved in the intervention Receives: Behavioral: Hold Me Tight |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyadic Adjustment Scale (DAS)
Measured: Change from Baseline in DAS scores at the end of the intervention and at three month follow-up
Beck Depression Inventory (BDI)
Measured: Change from Baseline in BDI scores at the end of the intervention and at three month follow-up
Beck Anxiety Inventory (BAI)
Measured: Change from Baseline in BAI scores at the end of the intervention and at three month follow-up
Secondary outcomes (2)
Hold Me Tight Conversations Rating Scale
Measured: 12 weeks and three month follow-up
Hold Me Tight Program Evaluation
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2011 (estimated)
- Study startJan 2012
- Primary completionApr 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marital RelationshipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Dalhousie University
- Responsible party
- Sponsor
- Investigators
- Robert J Allan, M.Ed., Principal investigator, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01405014
- Sponsor's protocol ID
- NCTHMT-ABI
- Status last verified
- Sep 2011
- First submitted
- 27 Jul 2011
- Last updated
- 7 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Hold Me Tight Relationship Enhancement Program With Couples Where One Partner Has an Acquired Brian Injury
- ClinicalTrials.gov ID
- NCT01405014
- Acronym / sponsor ID
- NCTHMT-ABI
- Conditions
- Marital Relationship
- Keywords
- Hold Me Tight, Emotionally Focused Therapy, Relationship enhancement, Couples counseling, Marital therapy, Acquired brain injury, Traumatic brain injury, Stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Dalhousie University
- Study start
- Jan 2012
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 29 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this research pilot project are to assess the efficacy of the Hold Me Tight Relationship Enhancement Program with couples where at least one partner has an acquired brain injury.
Detailed description
Families, and spouses in particular, have been shown to play important roles in all aspects of health care, especially when family members are recovering from the trauma of sudden illness or an accident such as a brain injury. A limited body of evidence suggests couple therapy provides patients and their spouses with the opportunity to explore the experience of trauma as it relates to becoming physically disabled within the context of intimate relationships. Being in close contact and emotionally connected to a person who has experienced trauma becomes a chronic stressor that can cause family members to experience trauma symptoms themselves. This phenomenon is termed secondary traumatic stress. For example, children can mimic a parent's trauma responses through identification with the parent or direct training. This is a specific type of secondary traumatisation transmitted intergenerationally.
The research about individuals who have a traumatic brain injury (TBI) and the impact of the injury on family functioning has outlined a number of challenges including: psychological distress, particularly anxiety and depression, among caregivers; disruptions in family functioning; and the impact on relationships including caregiver burden. Furthermore, among the most difficult conditions for couples to deal with are those involving cognitive impairment.
Hold Me Tight is a couples enrichment program that is based on the Emotionally Focused Therapy (EFT) approach to working with couples. EFT is an empirically supported treatment that arose out of emotion theory and attachment theory. It views emotions as centrally important in the experience of self, in both adaptive and maladaptive functioning, and in therapeutic change. From the EFT perspective change occurs by means of awareness, regulation, reflection, and transformation of emotion taking place within the context of an empathetically attuned relationship. There is significant research on this approach and it has been found that 70-75% of couples move from distress to recovery and that the gains are sustained for months to years following the end of treatment. As such, EFT is an evidence based treatment protocol.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Relationship enhancement group | Experimental | Behavioral: Hold Me TightOne group, all involved in the intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants must:
- be over the age of 18;
- be in a relationship at least 24 months and must be living together
- be at least 12 months post brain injury event
- be able to read and understand English, follow verbal instructions and provide verbal answers to questions;
Key exclusion criteria (6 listed)
- Participants must NOT:
- suffer from severe aphasia or dementia as determined by health chart;
- have active psychiatric illness;
- have other neurological condition(s);
- be couples where both partners have sustained a brain injury;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hold Me TightRelationship enhancement group | Behavioural | Relationship enhancement group |
Primary outcome
Dyadic Adjustment Scale (DAS)
Time frame: Change from Baseline in DAS scores at the end of the intervention and at three month follow-up
Beck Depression Inventory (BDI)
Time frame: Change from Baseline in BDI scores at the end of the intervention and at three month follow-up
Beck Anxiety Inventory (BAI)
Time frame: Change from Baseline in BAI scores at the end of the intervention and at three month follow-up
2 secondary outcomes
Hold Me Tight Conversations Rating Scale
Time frame: 12 weeks and three month follow-up
Hold Me Tight Program Evaluation
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert J Allan, M.Ed. principal investigator
Dalhousie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hold Me Tight in people with Marital Relationship, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyadic Adjustment Scale (DAS) (time frame: Change from Baseline in DAS scores at the end of the intervention and at three month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2012.