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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Dalhousie University
Information provided by (Responsible Party):
Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01405014
First received: July 27, 2011
Last updated: March 6, 2012
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Marital Relationship
Behavioral: Hold Me Tight
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Pilot Study of the Hold Me Tight Relationship Enhancement Program With Couples Where One Partner Has an Acquired Brian Injury

Resource links provided by NLM:


Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Dyadic Adjustment Scale (DAS) [ Time Frame: Change from Baseline in DAS scores at the end of the intervention and at three month follow-up ] [ Designated as safety issue: No ]
  • Beck Depression Inventory (BDI) [ Time Frame: Change from Baseline in BDI scores at the end of the intervention and at three month follow-up ] [ Designated as safety issue: No ]
  • Beck Anxiety Inventory (BAI) [ Time Frame: Change from Baseline in BAI scores at the end of the intervention and at three month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hold Me Tight Conversations Rating Scale [ Time Frame: 12 weeks and three month follow-up ] [ Designated as safety issue: No ]
  • Hold Me Tight Program Evaluation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2012
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Relationship enhancement group
One group, all involved in the intervention
Behavioral: Hold Me Tight
Relationship enhancement group

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01405014

Locations
Canada, Nova Scotia
Nova Scotia Rehabilitation Centre
Halifax, Nova Scotia, Canada, B3H 4K4
Sponsors and Collaborators
Capital District Health Authority, Canada
Dalhousie University
Investigators
Principal Investigator: Robert J Allan, M.Ed. Dalhousie University
  More Information

No publications provided

Responsible Party: Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT01405014     History of Changes
Other Study ID Numbers: NCTHMT-ABI
Study First Received: July 27, 2011
Last Updated: March 6, 2012
Health Authority: Canada: Health Canada

Keywords provided by Capital District Health Authority, Canada:
Hold Me Tight
Emotionally Focused Therapy
Relationship enhancement
Couples counseling
Marital therapy
Acquired brain injury
Traumatic brain injury
Stroke

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on July 28, 2014