Spinal Cord InjuryNCT02392052
Enhancing Self-Efficacy for Caregivers of Family Members With Spinal Cord Injury
A study testing Reinvention Protocol Participants and Wait List in people with Spinal Cord Injury, run by Craig Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Reinvention Protocol Participants and Wait List
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Living with a family member with SCI at any level for whom they are the primary caregiver;
- 18 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Spinal cord injury (SCI) may result in physical limitations such that receiving assistance from others is critical to maintaining health and facilitating full social integration. The assistance ranges from helping with basic daily activities such as bowel and bladder management, hygiene and dressing, to instrumental activities of daily living, including managing household finances, shopping, or transportation. The challenges that accompany a caregiving role may result in a caregiver's inability to balance responsibilities at home and in the workplace. In addition, there is a tendency for caregivers to neglect their own health, which may jeopardize the ability of the person with SCI to obtain the necessary care and support required for optimal independent functioning. Vulnerability and resilience to the ongoing stresses associated with caregiving for a loved one with SCI may be influenced by personal beliefs about the caregiver's capabilities for coping with them. People's belief about their capabilities for successfully performing tasks that affect their lives has been termed "self-efficacy".
For family caregivers of individuals with SCI, self-efficacy beliefs are essential for coping with the stressors that are experienced in the caregiving role. Anxiety, depression, and a sense of "losing" one's own identity are frequently reported by family caregivers. However, there has been relatively little research regarding caregiving in SCI and even fewer treatment options to enhance self-efficacy for these caregivers. The proposed study involves a randomized clinical trial to examine the effect of an intervention specifically designed by and for family caregivers to help improve self-efficacy and reduce emotional distress associated with it. The goal of this project is to test a six-week manualized, cognitive-behaviorally based group educational intervention to improve family caregivers' self-efficacy beliefs and skills, improve their resilience to the ongoing stresses associated with caregiving, and enhance their overall quality of life with the potential added benefit of improving the quality of life for their family members with SCI. Investigators hypothesize that by providing family caregivers with this educational intervention, the intervention can improve their self-efficacy skills as well as general life satisfaction, and minimize depression, stress and anxiety associated with caregiving. The proposed intervention consists of weekly facilitator-led sessions for a total of 6 weeks and includes didactic presentations of 8 key principles, discussion topics and experiential exercises such as 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 prior to the next meeting. Session content is organized around concepts of identifying and building character strengths, cultivating positive emotion through focusing on gratitude and on the good in one's life, experientially engaging in pleasurable activities, and accomplishing personal goals. The innovation of the proposed intervention lies in its integration of positive psychotherapy concepts into structured group CBT to develop optimistic self-efficacy beliefs, thereby strengthening the caregiver's resilience to emotional distress, enhancing a sense of well-being in the caregiver which, in turn, may benefit the family member with SCI.
- Conditions
- Spinal Cord Injury
- Being tested
- Reinvention Protocol Participants, Wait List
- Keywords
- caregivers
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reinvention Protocol ParticipantsBehavioural
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.
Wait ListBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Wait List |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 weeks, 18 weeks
Secondary outcomes (5)
Change in the Coping Self-Efficacy Scale (CSES) over an 18 week time period
The CSES is a questionnaire designed to assess changes in a person's confidence in his/her ability to cope effectively with a variety of challenges or threats.
Measured: Baseline, 6 weeks, 18 weeks
Change in the Revised Scale for Caregiving Self-Efficacy (RSCSE) over an 18 week time period
The RSCSE is a measure of self-efficacy for obtaining respite, responding to disruptive patient behaviors, and controlling upsetting thoughts about caregiving.
Measured: Baseline, 6 weeks, 18 weeks
The Diener Satisfaction with Life Scale (SWLS)
The SWLS will be used to measure global life satisfaction.
Measured: Baseline, 6 weeks, 18 weeks
Center for Epidemiological Studies Depression Scale (CES-D)
The CES-D is a screening instrument used to measure the current level of depressive symptomatology in general or clinical populations.
Measured: Baseline, 6 weeks, 18 weeks
General Anxiety Disorder 7-item (GAD-7)
The GAD-7 is a brief 7 item measure that will be used to assess the severity of general anxiety.
Measured: Baseline, 6 weeks, 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startNov 2015
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Craig Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cynthia Harrison-Felix, PhD, Craig Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392052
- Sponsor's protocol ID
- 713234
- Status last verified
- Jul 2019
- First submitted
- 12 Mar 2015
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Self-Efficacy for Caregivers of Family Members With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02392052
- Acronym / sponsor ID
- 713234
- Conditions
- Spinal Cord Injury
- Keywords
- caregivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Craig HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 18 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Spinal cord injury (SCI) may result in physical limitations such that receiving assistance from others is critical to maintaining health and facilitating full social integration. The assistance ranges from helping with basic daily activities such as bowel and bladder management, hygiene and dressing, to instrumental activities of daily living, including managing household finances, shopping, or transportation. The challenges that accompany a caregiving role may result in a caregiver's inability to balance responsibilities at home and in the workplace. In addition, there is a tendency for caregivers to neglect their own health, which may jeopardize the ability of the person with SCI to obtain the necessary care and support required for optimal independent functioning. Vulnerability and resilience to the ongoing stresses associated with caregiving for a loved one with SCI may be influenced by personal beliefs about the caregiver's capabilities for coping with them. People's belief about their capabilities for successfully performing tasks that affect their lives has been termed "self-efficacy".
For family caregivers of individuals with SCI, self-efficacy beliefs are essential for coping with the stressors that are experienced in the caregiving role. Anxiety, depression, and a sense of "losing" one's own identity are frequently reported by family caregivers. However, there has been relatively little research regarding caregiving in SCI and even fewer treatment options to enhance self-efficacy for these caregivers. The proposed study involves a randomized clinical trial to examine the effect of an intervention specifically designed by and for family caregivers to help improve self-efficacy and reduce emotional distress associated with it. The goal of this project is to test a six-week manualized, cognitive-behaviorally based group educational intervention to improve family caregivers' self-efficacy beliefs and skills, improve their resilience to the ongoing stresses associated with caregiving, and enhance their overall quality of life with the potential added benefit of improving the quality of life for their family members with SCI. Investigators hypothesize that by providing family caregivers with this educational intervention, the intervention can improve their self-efficacy skills as well as general life satisfaction, and minimize depression, stress and anxiety associated with caregiving. The proposed intervention consists of weekly facilitator-led sessions for a total of 6 weeks and includes didactic presentations of 8 key principles, discussion topics and experiential exercises such as 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 prior to the next meeting. Session content is organized around concepts of identifying and building character strengths, cultivating positive emotion through focusing on gratitude and on the good in one's life, experientially engaging in pleasurable activities, and accomplishing personal goals. The innovation of the proposed intervention lies in its integration of positive psychotherapy concepts into structured group CBT to develop optimistic self-efficacy beliefs, thereby strengthening the caregiver's resilience to emotional distress, enhancing a sense of well-being in the caregiver which, in turn, may benefit the family member with SCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reinvention Protocol Participants | Experimental | Behavioral: Reinvention Protocol ParticipantsThis 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. |
| Waitlist Group | Other | Behavioral: Wait ListThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Living with a family member with SCI at any level for whom they are the primary caregiver;
- 18 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reinvention Protocol ParticipantsA 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. | Behavioural | Reinvention Protocol Participants |
| Wait ListThis 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. | Behavioural | Waitlist Group |
Primary outcome
Change in General Self-Efficacy Scale scores over an 18week time period
Time frame: Baseline, 6 weeks, 18 weeks
The GSES is a questionnaire designed to assess a person's ability to cope with a variety of difficult demands in life.
5 secondary outcomes
Change in the Coping Self-Efficacy Scale (CSES) over an 18 week time period
Time frame: Baseline, 6 weeks, 18 weeks
Change in the Revised Scale for Caregiving Self-Efficacy (RSCSE) over an 18 week time period
Time frame: Baseline, 6 weeks, 18 weeks
The Diener Satisfaction with Life Scale (SWLS)
Time frame: Baseline, 6 weeks, 18 weeks
Center for Epidemiological Studies Depression Scale (CES-D)
Time frame: Baseline, 6 weeks, 18 weeks
General Anxiety Disorder 7-item (GAD-7)
Time frame: Baseline, 6 weeks, 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reinvention Protocol Participants and Wait List in people with Spinal Cord Injury, run by Craig Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in General Self-Efficacy Scale scores over an 18week time period (time frame: Baseline, 6 weeks, 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.