Depression Clinical Trial
Official title:
Preventing Persistent Post-Surgical Pain and Dysfunction in At-Risk Veterans: Effect of a Brief Behavioral Intervention
Primary Aim: To examine the superior efficacy of ACT versus Attention Control (AC) on postoperative pain intensity and functioning in at-risk Veterans undergoing TKA. Changes in pain intensity and functioning from baseline to 6 weeks, 3 months and 6 months post-TKA will be compared. Level of pain intensity will be measured using the BPI Pain Severity Subscale and level of functioning will be measured using the KOOS Activities of Daily Living and Quality Of Life Subscales. Secondary Aims: A) To examine the superior efficacy of ACT versus AC on the severity of anxiety and depressive symptoms and improvements in coping skills. Changes from baseline to 6 weeks, 3 months and 6 months post-TKA will be compared. Anxiety and depressive symptoms will be measured with the Hamilton Rating Scales (Ham-A and Ham-D, respectively). Coping skills (i.e. Pain Acceptance and Engagement in Values-Based Behavior) will be measured with the Chronic Pain Acceptance Questionnaire and the Chronic Pain Values Inventory. B) To evaluate whether decreases in distress-based symptoms and increases in coping skills mediate changes in pain and functioning at 6 months in Veterans receiving ACT. Changes in anxiety symptoms, depressive symptoms, pain acceptance and engagement in values-based behavior from baseline to 6 weeks and 3 months will be used as potential mediators for changes in pain and functioning at 6 months. Exploratory Aim: Describe the pharmacological and non-pharmacological strategies Veterans are using to manage pain and their perceived helpfulness. This will provide insights into the effects of the current opioid restrictions on pain management strategies. These strategies & their perceived helpfulness will be assessed using the Pain Management Strategies Survey at baseline, 6 weeks, 3, and 6 months.
Status | Recruiting |
Enrollment | 430 |
Est. completion date | November 30, 2024 |
Est. primary completion date | November 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - scheduled for unilateral total knee arthroplasty (TKA) - identified to be "at-risk" at the enrollment visit (i.e. worst pain =7 on BPI (severe pain) OR worst pain =3 (moderate pain) on BPI PLUS anxiety symptoms =6 on the Anxiety Subscale of the Depression, Anxiety and Stress Scale [DASS-21] or =10 on the Stress Subscale of the Depression, Anxiety and Stress Scale [DASS-21] OR depressive symptoms =7 on Depression Subscale of the Depression, Anxiety and Stress Scale [DASS-21] OR >20 on the Pain Catastrophizing Scale [PCS]. Exclusion Criteria: - inability to complete study forms/procedures because of a language/literacy barrier; - bipolar or psychotic disorder - history of brain injury - cognitive impairment (determined by score of <21 [high school or above] or <20 [< high school] on the Veterans Affairs Saint Louis University Mental Status [SLUMS] exam) - ACT therapy within the past year - inability to attend workshop prior to surgery |
Country | Name | City | State |
---|---|---|---|
United States | Iowa City VAMC | Iowa City | Iowa |
Lead Sponsor | Collaborator |
---|---|
Barbara A Rakel | Baylor College of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain Intensity | Pain will be measured using the Brief Pain Inventory (BPI) Short Form. | Baseline (preop) to 6 months post-surgery. | |
Primary | Function | Functioning will be measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS). | Baseline (preop) to 6 months post-surgery | |
Secondary | Anxiety | Anxiety will be measured using the Anxiety Subscale of the Depression, Anxiety and Stress Scale (DASS-21). | Baseline (preop) to 6 months post-surgery | |
Secondary | Depressive Symptoms | Depressive Symptoms will be measured using the Depression Subscale of the Depression, Anxiety and Stress Scale (DASS-21). | Baseline (preop) to 6 months post-surgery | |
Secondary | Level of Pain Acceptance | Pain Acceptance will be measured using the Chronic Pain Acceptance Questionnaire (CPAQ). | Baseline (preop) to 6 months post-surgery | |
Secondary | Level of Success in Engagement in Values-Based Behavior | Engagement in Values-Based Behavior will be measured using the Chronic Pain Values Inventory (CPVI). | Baseline (preop) to 6 months post-surgery | |
Secondary | Pain Management Strategies used | Pain Management Strategies will be measured using a Pain Management Strategies Survey (PMSS). | Baseline (preop) to 6 months post-surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
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