Enhancing Self-Efficacy for Caregivers of Family Members With Spinal Cord Injury

NCT02392052 | Completed

• 1 other identifier: 713234
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal cord injury (SCI) may result in physical deficits that require assistance from others in order to stay healthy and live independently in a community. The assistance provided by caregivers to a family member with SCI often involves a wide range of activities from helping with basic activities, like toileting and bathing, to managing more complex tasks, such as keeping up with household finances, shopping, and transportation. Caregiving puts demands on an individual's ability to cope and deal with day-to-day stresses, and may be influenced by personal beliefs about one's ability to cope with stress. Beliefs about our ability to perform tasks that affect our lives have been termed "self-efficacy". A strong sense of self-efficacy has been shown to positively impact life choices, motivation, quality of functioning, resilience to adversity, and vulnerability to stress and depression. People with low self-efficacy tend to avoid challenges, discontinue tasks that are difficult, and be at risk for more depression and stress, resulting in less satisfaction with life. This study uses a psychological strategy, called cognitive behavioral therapy (CBT), to enhance self-efficacy skills for caregivers of family members with SCI, with a focus on changing thinking styles to help people make emotional and behavioral changes. The investigators hypothesize that by providing family caregivers with a six week group educational intervention, their self-efficacy skills as well as general life satisfaction can be improved, and minimize depression, stress and anxiety that often accompany the caregiving role. The innovation of the proposed intervention is its integration of positive psychotherapy concepts into structured group CBT to develop optimistic self-efficacy beliefs, strengthen the caregiver's ability to deal with day-to-day stress, and enhance a sense of well-being in the caregiver which, in turn, may benefit the family member with SCI.

Conditions

Spinal Cord Injury

Keywords

caregivers

Outcome Measures

Primary Outcomes (1)

• Change in General Self-Efficacy Scale scores over an 18week time period

  The GSES is a questionnaire designed to assess a person's ability to cope with a variety of difficult demands in life.

  Baseline, 6 weeks, 18 weeks

Secondary Outcomes (5)

• Change in the Coping Self-Efficacy Scale (CSES) over an 18 week time period

  Baseline, 6 weeks, 18 weeks

• Change in the Revised Scale for Caregiving Self-Efficacy (RSCSE) over an 18 week time period

  Baseline, 6 weeks, 18 weeks

• The Diener Satisfaction with Life Scale (SWLS)

  Baseline, 6 weeks, 18 weeks

• Center for Epidemiological Studies Depression Scale (CES-D)

  Baseline, 6 weeks, 18 weeks

• General Anxiety Disorder 7-item (GAD-7)

  Baseline, 6 weeks, 18 weeks

Other Outcomes (1)

• Exploratory measure - Hair Cortisol

  Baseline, 6 weeks, 18 weeks

Study Arms (2)

Reinvention Protocol Participants

EXPERIMENTAL

This group will receive 6 instructor-led 2 hour long didactic presentations regarding 8 key principles of self-efficacy and experiential exercises, including goal setting and problem solving with extensive group discussion. At the end of each session, tasks are assigned to participants to be completed outside the group during the week between sessions. Experiences from these activities and practice implementing the intervention principles will be shared and discussed each week, providing additional opportunities for problem solving and positive feedback.

Behavioral: Reinvention Protocol Participants

Waitlist Group

OTHER

This group will include individuals randomized to receive no treatment for the 18 weeks during which the interventional group will receive the active treatment and have their progress tracked.

Behavioral: Wait List

Interventions

Reinvention Protocol Participants BEHAVIORAL

A cognitive behavioral therapy (CBT), to enhance self-efficacy skills for caregivers of family members with SCI, with a focus on changing thinking styles to help people make emotional and behavioral changes.

Reinvention Protocol Participants

Wait List BEHAVIORAL

This group will include individuals randomized to receive no treatment for the 18 weeks during which the interventional group will receive the active treatment and have their progress tracked.

Waitlist Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Living with a family member with SCI at any level for whom they are the primary caregiver;
• years of age or older at the time of study enrollment;
• English speaking in order to complete study measures and participate in group interactions;
• score of 30 or lower on the GSES; and
• able to provide informed consent to participate.

You may not qualify if:

• Not providing any amount of assistance to a family member with SCI;
• not related through marriage or blood to the person with SCI;
• lives beyond a reasonable commuting distance from Craig Hospital;
• unable to verbally communicate;
• unable to attend group sessions;
• active participation in another formal clinical group or psychological therapy; or
• have any condition that, in the judgment of the investigators, precludes successful participation in the study.

Sponsors & Collaborators

• Craig Hospital: lead

Study Sites (1)

Craig Hospital

Englewood, Colorado, 80113, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Study Record Dates

• First Submitted: March 12, 2015
• First Posted: March 18, 2015
• Study Start: November 1, 2015
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: July 23, 2019

Record last verified: 2019-07

Locations

US (1)