CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 59 enrolled
Drug / intervention
Resistance training +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04026152
NCT04026152N/ACompleted

Using the Unified Protocol to Reduce Exercise Anxiety and Improve Adherence to a Resistance Training Program for People With Anxiety-Related Disorders: A Randomized Controlled Trial

University of Regina·interventional·Posted Jul 19, 2019·Updated Feb 5, 2021

In Brief

A clinical study evaluating Resistance training and Unified Protocol for Anxiety Disorders and 2 related conditions. Completed, enrolled 59 participants across 1 site.

Detailed Summary

Anxiety-related disorders such as panic disorder, social anxiety disorder, generalized anxiety disorder, and posttraumatic stress disorder are among the most prevalent mental health disorders affecting Canadian adults. Lack of access to evidence-based treatments prevents many people with high levels of anxiety from receiving appropriate care. Evidence shows that exercise is an alternative option for alleviating anxiety that could be appealing to individuals with high levels of anxiety who are unable, or unwilling, to access other evidence-based treatments. Unfortunately, people with high levels of anxiety tend to have a hard time using exercise independently as a strategy to manage their anxiety, in part, because many aspects of exercising can be anxiety-provoking (e.g., physical sensations produced by exercise, opportunities for evaluation by others, crowded exercise environments). Cognitive-behavioral techniques are therapeutic tools that could help these people overcome their anxiety about exercising and support them as they make positive health behavioural changes; however, however, no study to date has explored this possibility. The proposed study will use rigorous experimental techniques to determine whether an exercise-focused cognitive behavioural psychological intervention can support people with anxiety-related disorders to become more physically active and experience the reductions in anxiety that comes from making this lifestyle change.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJul 19, 2019
Enrollment StartJul 14, 2019
Primary CompletionAug 1, 2020
Study CompletionSep 1, 2020
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 7.0 years ago

Interventions

Resistance trainingbehavioral

Following randomization, all participants assigned to receive the resistance training intervention will receive a comprehensive exercise program. The exercise program participants will be using is similar to past research using resistance training programs with people with anxiety-related disorders and has been developed and reviewed by a team of certified personal trainers, including the primary investigator. All participants assigned receive this resistance training intervention will complete a total of six sessions with a personal trainer and six session independently over four weeks to allow for a gradual, rather than abrupt, transition to fully independently completed exercise by the 4th week. After this time participants will be encouraged to exercise independently.

Unified Protocolbehavioral

This intervention consists four weekly sessions adapted from the Unified Protocol. The first module is Psychoeducation and Motivational Interviewing. During this module, participants will develop an understanding of their own pattern of emotional responding to exercise as well as increasing participants' readiness and motivation for behaviour change.The second module is Cognitive Flexibility, during which participants will learn about how automatic negative interpretations can influence their emotional reactions and prevent them from considering alternative explanations. The third module is Countering Emotion-Driven Behaviours during which participants will identify and counter behaviours used to dampen strong emotions, particularly those associated with exercise. Lastly, module four will use Exposure to external and internal emotional triggers to increase participants' tolerance to the emotions that arise in exercise environments.