Outcome Study of Hold Me Tight Program With Acquired Brian Injury (ABI) Populations

Marital Relationship Clinical Trial

Official title:

Pilot Study of the Hold Me Tight Relationship Enhancement Program With Couples Where One Partner Has an Acquired Brian Injury

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01405014
• Other study ID #: NCTHMT-ABI
• Status: Withdrawn
• Phase: Phase 3
• First received: July 27, 2011
• Last updated: March 6, 2012
• Start date: January 2012
• Est. completion date: July 2012

Study information

• Verified date: September 2011
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Marital Relationship

Intervention

Behavioral:
• Hold Me Tight
Relationship enhancement group

Locations

Country	Name	City	State
Canada	Nova Scotia Rehabilitation Centre	Halifax	Nova Scotia

Sponsors (2)

Lead Sponsor	Collaborator
Nova Scotia Health Authority	Dalhousie University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dyadic Adjustment Scale (DAS)		Change from Baseline in DAS scores at the end of the intervention and at three month follow-up	No
Primary	Beck Depression Inventory (BDI)		Change from Baseline in BDI scores at the end of the intervention and at three month follow-up	No
Primary	Beck Anxiety Inventory (BAI)		Change from Baseline in BAI scores at the end of the intervention and at three month follow-up	No
Secondary	Hold Me Tight Conversations Rating Scale		12 weeks and three month follow-up	No
Secondary	Hold Me Tight Program Evaluation		12 weeks	No