Delivering ICBT to Address Mental Health Challenges in Correctional Officers and Other Public Safety Personnel

NCT04666974 | Completed

• 1 other identifier: PSIY-684-20
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Public safety personnel (PSP) have regular and often intense exposure to potentially traumatic events at work and are at higher risk for developing mental health problems such as posttraumatic stress disorder (PTSD). Studies have shown up to 4 times higher suicidal ideation, attempt and death among this population compared to the general population. Despite the high rate of mental health problems among PSPs, their willingness to receive mental healthcare support is fairly low, mainly due to the stigma attached to these disorders. Those who are willing to seek help face unique barriers including their irregular shift hours, limiting their access to resources otherwise available to the public. Given these challenges and the critical contribution of PSPs to public safety, developing innovative solutions to address their mental health must be a healthcare priority. This proposal aims to study the efficacy of using an innovative approach in delivering mental health online, to address mental health problems among correctional workers (CW), who are especially prone to mental health problems given the high rate of workplace violence. It is hypothesized that using an online platform to deliver cognitive behavioural therapy (CBT), would lower the stigma of receiving care in a secure and confidential environment, easing CW's concerns about stigma from co-workers. The content is delivered through interactive and engaging therapy modules, designed for specific groups of CWs and customized by situational examples to make therapy more relatable. These online modules would provide CWs with 24/7 access to therapy content, solving the irregular work hour problem. The online CBT modules developed in this study would provide high quality and clinically validated resources to address mental health problems of CWs all across Canada. Knowledge acquired through this project could also be beneficial to using iCBT in general for addressing mental health challenges among other PSPs.

Conditions

Mental Health Issue; Anxiety Disorders; Depressive Disorder; Post-Traumatic Stress Disorder

Keywords

Clinical; Population Health; Correctional Workers; Online Psychotherapy; Mental Health Issues; Online Cognitive Behavioural Therapy

Outcome Measures

Primary Outcomes (6)

• Change in Symptoms (Depression and Anxiety Scale - DASS 42 Item)

  Questionnaire for symptomlogy changes. Scale of 0-3, 3 is worse.

  Baseline, week 2, 4, 6, 8, 10, 12, 6-month follow-up, 12-month follow-up

• Change in Symptoms (Quality of Life Enjoyment and Satisfaction - Q-LES-Q)

  Questionnaire for symptomlogy changes. Scale of 0-5, 5 is best

  Baseline, week 2, 4, 6, 8, 10, 12, 6-month follow-up, 12-month follow-up

• Change in Symptoms (Quick Inventory of Depressive Symptoms Self Report - QIDS-SR 16 Item)

  Questionnaire for symptomlogy changes. Scale of 0-3, 3 is worse.

  Baseline, week 2, 4, 6, 8, 10, 12, 6-month follow-up, 12-month follow-up

• Change in Symptoms (Patient Health Questionnaire - PHQ 9 Item)

  Questionnaire for symptomlogy changes. Scale of 0-3. 3 is worse.

  Baseline, week 2, 4, 6, 8, 10, 12, 6-month follow-up, 12-month follow-up

• Change in Symptoms (Generalized Anxiety Disorder - GAD 7)

  Questionnaire for symptomlogy changes. Scale of 0-3, 3 is worse.

  Baseline, week 2, 4, 6, 8, 10, 12, 6-month follow-up, 12-month follow-up

• Change in Symptoms (PTSD Checklist - PCL-5)

  Questionnaire for symptomlogy changes. Scale of 0-4, 4 is worse.

  Baseline, week 2, 4, 6, 8, 10, 12, 6-month follow-up, 12-month follow-up

Study Arms (4)

Phase 3: iCBT + Treatment As Usual

EXPERIMENTAL

CWs in the iCBT group, will be assigned to one the six therapy modules, based on their gender and diagnosis (i.e. Female/Male \* GAD, MDD or PTSD). Each CW will be assigned a specific clinician (a trained psychiatrist/psychologist/ social worker) who would be their care liaison through the study. Each week, the clinician would send one session of the 12-session curriculum to the CW on a pre-determined day of the week. Each weekly session consists of 20-30 slides followed by a homework assignment. It usually takes 40-60 minutes for a participant to complete one weekly session which they have to complete by a specific day of the week. The clinician will review the CW's assignments and provide feedback on their performance. The clinician feedback is structured and takes approximately 15 minutes to complete. The clinician will then send the content for the next session along with the feedback.

Behavioral: iCBT

Phase 3: Treatment as Usual

NO INTERVENTION

Participants will complete clincally validated questionnaires to measure symptoms while continuing with their regular daily activities and treatments (if any) (i.e., exercise, diet, medications, etc.)

Phase 4: iCBT + Treatment as Usual

EXPERIMENTAL

Participants will be randomly assigned to this group and take part in the iCBT module program from phase 3.

Behavioral: iCBT

Phase 4: In-Person CBT + Treatment as Usual

ACTIVE COMPARATOR

Participants will be randomly assigned to this group and complete in-person CBT with similar content, homework, and feedback as in the iCBT + TAU group. All in-person CBT will be delivered by a trained professional and each session will take approximately 60-75 minutes.

Behavioral: In-Person CBT

Interventions

iCBT BEHAVIORAL

Online CBT modules will be completed weekly with content mirroring in-person CBT for their diagnosis. Homework will be submitted weekly through the OPTT platform which will be reviewed by a trained professional who will provide personalized feedback.

Phase 3: iCBT + Treatment As Usual; Phase 4: iCBT + Treatment as Usual

In-Person CBT BEHAVIORAL

Participants will be assigned to in-person CBT that will mirror the content and homework covered in the iCBT group. It will be delivered by professionals and attended weekly.

Phase 4: In-Person CBT + Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Correctional worker or public safety personnel
• Diagnosis of either Major Depressive Disorder, Generalized Anxiety Disorder, or Post-Traumatic Stress Disorder
• Competence to provide informed consent and participate
• Speak and read English
• Consistent and reliable access to the internet

You may not qualify if:

• Diagnosis of hypomanic/manic episodes
• Psychosis
• Severe alcohol or substance abuse disorder
• Active suicidal or homicidal ideation

Sponsors & Collaborators

• Dr. Nazanin Alavi: lead
• Online PsychoTherapy Clinic: collaborator

Study Sites (1)

Hotel Dieu Hospital

Kingston, Ontario, K7L 5G3, Canada

Location

Related Publications (1)

• Alavi N, Stephenson C, Omrani M, Gerritsen C, Martin MS, Knyahnytskyi A, Zhu Y, Kumar A, Jagayat J, Shirazi A, Moghimi E, Patel C, Knyahnytska Y, Simpson AIF, Zaheer J, Andersen J, Munshi A, Groll D. Delivering an Online Cognitive Behavioral Therapy Program to Address Mental Health Challenges Faced by Correctional Workers and Other Public Safety Personnel: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2021 Jul 22;10(7):e30845. doi: 10.2196/30845.

  PMID: 34088656 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depressive Disorder; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Mental Disorders; Mood Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Nazanin Alavi

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Principle Investigator

Model Details: Participants in Phase 3 will be randomly assigned to either iCBT + Treatment as Usual or just Treatment as Usual. In phase 4, participants will be randomly assigned to either iCBT + Treatment as Usual or in-person CBT + Treatment as Usual.

Study Record Dates

• First Submitted: December 5, 2020
• First Posted: December 14, 2020
• Study Start: July 1, 2020
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: October 18, 2024

Record last verified: 2024-10

Locations

CA (1)