ADHD Clinical Trial
Official title:
Treatment of Psychosomatic Pain in Youth (ToPSY): A Pilot Study
The purpose of this study is to examine whether an integrative group-based intervention will help children experiencing psychological and physical distress. Children, ages 10 to 12, will be recruited for participation in this therapeutic group. Eligible and consenting participants will be randomized to a wait-list control group or the group intervention. The group intervention will take place over a 12-week period, during which participants will attend a weekly coping skills group that integrates yoga-based practices (such as yoga poses, mindfulness, self-acceptance, breath work) with cognitive-behavioral principles (such as increasing awareness of thoughts and emotions).
Psychosomatic symptoms are physical complaints in the absence of an organic cause. For
children and adolescents, psychosomatic symptoms often manifest as headaches,
gastrointestinal (GI) discomfort, non-specific musculoskeletal pain, and fatigue. These
symptoms are strongly associated with the presence of an internalizing disorder—namely,
anxiety or depression—in youth. Thus, treatment of these symptoms has often been cached
within a broader intervention protocol, the overarching goal of which is to address the
global internalizing disorder. For children who experience intense and persistent
psychosomatic discomfort, however, it can be critical to specifically target these symptoms
through intensive intervention. Otherwise, psychosomatic complaints can be extremely
impairing, impeding children's attendance in school, participation in extracurricular
activities, and disrupting family activities. At present, there are few systematic that can
target a range of psychosomatic problems.
Yoga-based interventions may be a particularly valuable treatment for children with
psychosomatic complaints. Such interventions have been studied empirically in adults with a
number of psychosomatic conditions, and more recently in children with a variety of
psychological conditions. Indeed, there have been a small number of studies targeting
psychosomatic complaints in children via yogic practices. Although there is emerging
interest in yoga-based interventions for youth, and slowly growing evidence their efficacy,
at present there are no known structured interventions for youth with psychosomatic
complaints in the context of an internalizing disorder. Thus, the goal of the present
proposal is to develop a semi-structured, manualized intervention that targets impairing
psychosomatic symptoms in youth with a comorbid internalizing disorders. The specific aims
are as follows:
Specific Aim 1 Treatment Feasibility: Assess the feasibility of a novel integrative coping
intervention for children with somatic symptoms and anxiety.
Hypothesis: The yoga-based intervention will be acceptable and feasible for children.
Acceptability will be defined as a 50% consent rate among participants approached for the
study; Feasibility will be defined by 75% of children completing 80% of intervention
sessions.
Secondary Aim 1 Treatment Efficacy: Assess the preliminary efficacy of a 12-week integrative
coping intervention on both somatic and psychological (e.g., anxiety, mood) symptoms
compared to a wait-list control condition.
Hypothesis: Children in the active intervention condition will have a significant reduction
in somatic and anxiety symptoms following the 12-week intervention compared to a wait-list
control.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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