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

Primary Purpose

Marital Relationship

Status
Withdrawn
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Hold Me Tight
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Marital Relationship focused on measuring Hold Me Tight, Emotionally Focused Therapy, Relationship enhancement, Couples counseling, Marital therapy, Acquired brain injury, Traumatic brain injury, Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nova Scotia Rehabilitation Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Relationship enhancement group

Arm Description

One group, all involved in the intervention

Outcomes

Primary Outcome Measures

Dyadic Adjustment Scale (DAS)
Beck Depression Inventory (BDI)
Beck Anxiety Inventory (BAI)

Secondary Outcome Measures

Hold Me Tight Conversations Rating Scale
Hold Me Tight Program Evaluation

Full Information

First Posted
July 27, 2011
Last Updated
March 6, 2012
Sponsor
Nova Scotia Health Authority
Collaborators
Dalhousie University
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1. Study Identification

Unique Protocol Identification Number
NCT01405014
Brief Title
Outcome Study of Hold Me Tight Program With Acquired Brian Injury (ABI) Populations
Official Title
Pilot Study of the Hold Me Tight Relationship Enhancement Program With Couples Where One Partner Has an Acquired Brian Injury
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Withdrawn
Study Start Date
January 2012 (undefined)
Primary Completion Date
April 2012 (Anticipated)
Study Completion Date
July 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nova Scotia Health Authority
Collaborators
Dalhousie University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marital Relationship
Keywords
Hold Me Tight, Emotionally Focused Therapy, Relationship enhancement, Couples counseling, Marital therapy, Acquired brain injury, Traumatic brain injury, Stroke

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Relationship enhancement group
Arm Type
Experimental
Arm Description
One group, all involved in the intervention
Intervention Type
Behavioral
Intervention Name(s)
Hold Me Tight
Intervention Description
Relationship enhancement group
Primary Outcome Measure Information:
Title
Dyadic Adjustment Scale (DAS)
Time Frame
Change from Baseline in DAS scores at the end of the intervention and at three month follow-up
Title
Beck Depression Inventory (BDI)
Time Frame
Change from Baseline in BDI scores at the end of the intervention and at three month follow-up
Title
Beck Anxiety Inventory (BAI)
Time Frame
Change from Baseline in BAI scores at the end of the intervention and at three month follow-up
Secondary Outcome Measure Information:
Title
Hold Me Tight Conversations Rating Scale
Time Frame
12 weeks and three month follow-up
Title
Hold Me Tight Program Evaluation
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J Allan, M.Ed.
Organizational Affiliation
Dalhousie University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nova Scotia Rehabilitation Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 4K4
Country
Canada

12. IPD Sharing Statement

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

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