RECHARGE: A Brief Psychological Intervention to Build Resilience in Healthcare Workers During COVID-19

Sponsor

Naser Morina (Other)

Overall Status

Recruiting

CT.gov ID

NCT04531774

Collaborator

The University of New South Wales (Other)

160

Enrollment

Location

Arms

9.1

Anticipated Duration (Months)

17.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The healthcare industry is inherently demanding, stressful, and, at times, emotionally draining. On a typical day, many workers must make rapid and critical decisions, manage numerous demands, team conflicts, and challenging situations with patients and their families. For some health care workers (HCW), the current pandemic - COVID-19 - has also exacerbated these challenges. Providing psychological support is key in alleviating stress among HCWs, yet the situation does not require therapy because HCWs do not principally suffer from a mental disorder. RECHARGE was specifically developed for HCWs and is an abbreviated online version of Problem Management Plus, an evidence-based intervention that helps to cope with stress in times of crisis. As a brief psychological intervention for adults affected by adversity emerging from stress exposure, RECHARGE teaches people three well-documented strategies to manage acute stress (a: managing stress, b: managing worry, c: meaningful activity). It includes psychoeducation, arousal reduction techniques, managing worries and problem-solving skills, behavioral activation, and enhancement of meaningful activities, which are all based on the principles of cognitive-behavioral therapy. The aim of this study is to evaluate the efficacy of RECHARGE to reduce stress in HCWs and enhance their work performance. Participants in this randomized controlled trial (RCT) study are randomly assigned to either RECHARGE or the active control group. To this end, stress including symptoms of burnout, worries, anxiety, depression, PTSD, and work performance will be measured at baseline, post-intervention, and at a 2 and 6 month follow up.

Condition or Disease	Intervention/Treatment	Phase
Stress Burnout Anxiety Depression Covid19	Behavioral: RECHARGE Behavioral: Self Study	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

RECHARGE: A Brief Psychological Intervention to Build Resilience in Healthcare Workers During COVID-19

Actual Study Start Date :

Aug 28, 2020

Anticipated Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RECHARGE 4 1-hour sessions of RECHARGE are delivered online using Skype for Business within 2 weeks.	Behavioral: RECHARGE RECHARGE is an abbreviated and adapted version of Problem Management Plus (PM+), an evidence-based intervention that helps to cope with stress in times of crisis. Recharge is specifically developed for HCWs as a brief psychological intervention for adults affected by adversity emerging from stress exposure and teaches people three well-documented strategies to manage acute stress. The strategies are: a) managing stress, b) managing worry, c) meaningful activity. It includes psychoeducation, arousal reduction techniques, managing worries and problem-solving skills, behavioural activation, enhancement of meaningful activities, and relapse prevention, which are all based on the principles of cognitive-behavioural therapy. RECHARGE is delivered online in a 1 to 1 setting between coach and participant. Trained peers (medical doctors, nurses, psychologists) act as coaches.
Active Comparator: Online self-study of stress management strategies Self study during 2 weeks.	Behavioral: Self Study HCWs are referred to a few recommended webpages that outline well-validated, adaptive coping strategies for managing stress.

Arm

Intervention/Treatment

Experimental: RECHARGE

4 1-hour sessions of RECHARGE are delivered online using Skype for Business within 2 weeks.

Behavioral: RECHARGE

RECHARGE is an abbreviated and adapted version of Problem Management Plus (PM+), an evidence-based intervention that helps to cope with stress in times of crisis. Recharge is specifically developed for HCWs as a brief psychological intervention for adults affected by adversity emerging from stress exposure and teaches people three well-documented strategies to manage acute stress. The strategies are: a) managing stress, b) managing worry, c) meaningful activity. It includes psychoeducation, arousal reduction techniques, managing worries and problem-solving skills, behavioural activation, enhancement of meaningful activities, and relapse prevention, which are all based on the principles of cognitive-behavioural therapy. RECHARGE is delivered online in a 1 to 1 setting between coach and participant. Trained peers (medical doctors, nurses, psychologists) act as coaches.

Active Comparator: Online self-study of stress management strategies

Self study during 2 weeks.

Behavioral: Self Study

HCWs are referred to a few recommended webpages that outline well-validated, adaptive coping strategies for managing stress.

Outcome Measures

Primary Outcome Measures

Change from Baseline in psychological distress Kessler Psychological Distress Scale (K10) at Week 5 and Week 13 [Baseline (Week 1), post-intervention (Week 5) and 2 month follow-up (Week 13)]
HCWs in the intervention condition (RECHARGE) demonstrate a lower level of distress after the intervention and at 2-month follow-up than HCWs in the active control condition.

Secondary Outcome Measures

Fewer worries in intervention group than in active control group [post-intervention (Week 5) and 2 month follow-up (Week 13)]
HCWs in the intervention condition demonstrate fewer worries after the intervention and at 2-month follow-up than HCWs in the active control condition. Worries are measured using the Generalized Anxiety Disorder Assessment (GAD-7)
Less anxiety symptoms in intervention group than in active control group [post-intervention (Week 5) and 2 month follow-up (Week 13)]
HCWs in the intervention condition demonstrate less anxiety after the intervention and at 2-month follow-up than HCWs in the active control condition. Anxiety is measured using the Hospital Anxiety and Depression Scale (HADS).
Fewer depression symptoms in intervention group than in active control group [post-intervention (Week 5) and 2 month follow-up (Week 13)]
HCWs in the intervention condition demonstrate fewer symptoms of depression after the intervention and at 2-month follow-up than HCWs in the active control condition. Depression is measured using the Hospital Anxiety and Depression Scale (HADS).
Lower level of burnout in intervention group than in active control group [post-intervention (Week 5) and 2 month follow-up (Week 13)]
HCWs in the intervention condition demonstrate a lower level of burnout after the intervention and at 2-month follow-up than HCWs in the active control condition. Burnout is measured using the Maslach Burnout Inventory (MBI).
Less traumatic stress in intervention group than in active control group [post-intervention (Week 5) and 2 month follow-up (Week 13)]
HCWs in the intervention condition demonstrate less traumatic stress after the intervention and at 2-month follow-up than HCWs in the active control condition. Traumatic stress is measured using the PTSD Checklist (PCL-5).
Lower level of distress due to perceived moral injury in intervention group than in active control group [post-intervention (Week 5) and 2 month follow-up (Week 13)]
HCWs in the intervention condition demonstrate a lower level of distress due to perceived moral injury after the intervention and at 2-month follow-up than HCWs in the active control condition. Distress due to perceived moral injury is measured using Moral Injury Appraisals (MI).
Higher work performance in intervention group than in active control group [post-intervention (Week 5) and 2 month follow-up (Week 13)]
HCWs in the intervention condition demonstrate a higher work performance after the intervention and at 2-month follow-up than HCWs in the active control condition. Work performance is measured using the Work Ability Index (WAI).