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Sponsors and Collaborators: |
Medical College of Wisconsin Children's Hospital and Health System Foundation, Wisconsin |
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Information provided by: | Medical College of Wisconsin |
ClinicalTrials.gov Identifier: | NCT00804180 |
The specific aim of this project is to determine the impact of this group therapy intervention on improving adherence, coping, and functioning among children and adolescents with disease processes requiring injections who experience injection-related anxiety.Hypotheses include:
Condition | Intervention |
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Anxiety |
Behavioral: Self-Injection Anxiety Counseling |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Evaluation of a Group Therapy Intervention for Children and Adolescents With Injection-Related Anxiety and Their Caregivers |
Estimated Enrollment: | 50 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Coping skills intervention
Evaluation of a group treatment for injection-related anxiety. The intention of the study is to obtain basic evaluation of a clinical treatment offered in a natural clinic setting, and does not include a control group, or procedure for random assignment of participants.
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Behavioral: Self-Injection Anxiety Counseling
This 5-session group intervention involves: psychoeducation; physiological treatment of anxiety though the instruction and practice of relaxation techniques; cognitive restructuring for anxiety-reduction; practice physiological and cognitive treatments through in vivo injection procedures; and problem solving strategies to generalize treatment gains.
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The proposed intervention protocol is a modification of an existing empirically developed treatment (Self-Injection Anxiety Counseling) for adults with injection related anxiety who rely on self-injection for illness management (Mohr, Cox, & Boudewyn, 2003). Self-Injection Anxiety Counseling (SIAC) was developed to assist psychologists and medical staff in working with patients individually to develop strategies to reduce anxiety and increase an individual's ability to self-inject. This treatment protocol has been found to result in increased self injection in patients who experienced injection anxiety prior to undergoing this treatment (Mohr, Cox, & Merluzzi, 2005). Permission has been obtained from Dr. Mohr to modify this treatment manual to be applied to youth in group setting.
This modified group protocol consists of five group sessions. The goals of the first session include development of a group identity, psychoeducation, and physiological treatment of anxiety though the instruction and practice of relaxation techniques. The second session introduces a cognitive component to anxiety reduction and focuses on unhelpful thoughts and strategies youth and caregivers can use to counteract these thoughts. The third session implements the previously learned physiological and cognitive treatments through in vivo injection practice. A registered nurse skilled in working with youth and caregivers on self-injection will be present and active throughout this session and all infection control procedures will be followed. Problem solving strategies are implemented in the fourth session to reduce any difficulties encountered by participants as they practiced their injection goal throughout the week. The fifth session will occur two weeks after the fourth session. This extra week between sessions allows for additional practice and problem solving related to injection goals. The last session reviews problem solving strategies and celebrates the success of participants.
Relevant outcomes for hypotheses testing will be measured before treatment, after completion of treatment, and at follow-up; one measure of injection-related anxiety will be utilized more frequently throughout the treatment.
Ages Eligible for Study: | 8 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Matthew D Jandrisevits, PhD | 414-266-7483 | mjandrisevits@chw.org |
Contact: Elizabeth Fischer, PhD | 414-266-2932 |
United States, Wisconsin | |
Children's Hospital of Wisconsin | Recruiting |
Milwaukee, Wisconsin, United States, 53201-1997 | |
Contact: Matthew D Jandrisevits, PhD 414-266-7483 mjandrisevits@chw.org | |
Contact: Elizabeth Fischer, PhD 414-266-2932 |
Principal Investigator: | Matthew D Jandrisevits, PhD | Children's Hospital and Health System Foundation, Wisconsin |
Responsible Party: | Children's Hospital of Wisconsin ( Matthew D. Jandrisevits, Ph.D. ) |
Study ID Numbers: | CHW 08/137, GC 742 |
Study First Received: | December 5, 2008 |
Last Updated: | December 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00804180 |
Health Authority: | United States: Institutional Review Board |
anxiety injection needle pediatric youth children adolescents |
cognitive behavioral behavioral exposure group treatment chronic illness adherence |
Chronic Disease |