NCT01405014

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

March 7, 2012

Status Verified

September 1, 2011

Enrollment Period

3 months

First QC Date

July 27, 2011

Last Update Submit

March 6, 2012

Conditions

Marital Relationship

Keywords

Hold Me TightEmotionally Focused TherapyRelationship enhancementCouples counselingMarital therapyAcquired brain injuryTraumatic brain injuryStroke

Outcome Measures

Primary Outcomes (3)

  • Dyadic Adjustment Scale (DAS)

    Change from Baseline in DAS scores at the end of the intervention and at three month follow-up

  • Beck Depression Inventory (BDI)

    Change from Baseline in BDI scores at the end of the intervention and at three month follow-up

  • Beck Anxiety Inventory (BAI)

    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

    12 weeks and three month follow-up

  • Hold Me Tight Program Evaluation

    12 weeks

Study Arms (1)

Relationship enhancement group

EXPERIMENTAL

One group, all involved in the intervention

Behavioral: Hold Me Tight

Interventions

Hold Me TightBEHAVIORAL

Relationship enhancement group

Relationship enhancement group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nova Scotia Rehabilitation Centre

Halifax, Nova Scotia, B3H 4K4, Canada

Location

MeSH Terms

Conditions

Brain InjuriesBrain Injuries, TraumaticStroke

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesCerebrovascular DisordersVascular DiseasesCardiovascular Diseases

Study Officials

  • Robert J Allan, M.Ed.

    Dalhousie University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2011

First Posted

July 29, 2011

Study Start

January 1, 2012

Primary Completion

April 1, 2012

Study Completion

July 1, 2012

Last Updated

March 7, 2012

Record last verified: 2011-09

Locations

CA(1)