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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01405014
• Date of registration: 27/07/2011
• Prospective Registration: Yes
• Primary sponsor: Capital District Health Authority, Canada
• Public title: Outcome Study of Hold Me Tight Program With Acquired Brian Injury (ABI) Populations
• Scientific title: Pilot Study of the Hold Me Tight Relationship Enhancement Program With Couples Where One Partner Has an Acquired Brian Injury
• Date of first enrolment: January 2012
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT01405014
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
• Phase: Phase 3

Countries of recruitment

Canada

Contacts

• Name: Robert J Allan, M.Ed.
• Affiliation: Dalhousie University

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Marital Relationship

Intervention(s)

Behavioral: Hold Me Tight

Primary Outcome(s)

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]

Dyadic Adjustment Scale (DAS) [Time Frame: Change from Baseline in DAS scores at the end of the intervention and at three month follow-up]

Secondary Outcome(s)

Hold Me Tight Conversations Rating Scale [Time Frame: 12 weeks and three month follow-up]

Hold Me Tight Program Evaluation [Time Frame: 12 weeks]

Secondary ID(s)

NCTHMT-ABI

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Dalhousie University