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Couple HOPES (Helping Overcome PTSD and Enhance Satisfaction) (HOPES)

Primary Purpose

Posttraumatic Stress Disorder

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Couple HOPES Guided, Internet-Delivered, Self-Help Intervention
Sponsored by
Toronto Metropolitan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Self-help, Internet-delivered intervention

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Individual who is a Canadian military member, veteran, or first responder with clinically significant levels of PTSD symptoms
  • Must be willing to be audio-recorded for coaching sessions
  • Intimate partner willing to participant and complete intervention modules together
  • Access to high speed internet

Exclusion Criteria:

  • Elevated suicide risk
  • Severe physical aggression between partners in the past year
  • Clinically significant PTSD symptoms in both members of the dyad

Sites / Locations

  • Candice M. Monson

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Immediate Couple HOPES

Delayed Intervention

Arm Description

Immediately assigned to receive seven modules of an Internet-delivered self-help intervention with paraprofessional coaching for PTSD completed at the participant's own pace within 8 weeks.

Participants will not receive Couple HOPES for the first 8 weeks, and complete assessments at the beginning, middle, and end of this period. After this 8-week delay, participants will then receive seven modules of an Internet-delivered self-help intervention with paraprofessional coaching for PTSD completed at the participant's own pace within 8 weeks.

Outcomes

Primary Outcome Measures

PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5) with change measured as mean change from baseline
Scores on the PCL-5 range from 0 to 80, with 80 being the most severe PTSD symptoms.
Couple Satisfaction Index (CSI-4) with change measured as mean change from baseline
Score on the CSI-4 range from 0 to 21, with 21 being the most satisfied.

Secondary Outcome Measures

Mean change from baseline on Ineffective Arguing Inventory
Score range from 0 to 40, with 40 representing highly ineffective arguing.

Full Information

First Posted
December 18, 2019
Last Updated
May 3, 2023
Sponsor
Toronto Metropolitan University
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1. Study Identification

Unique Protocol Identification Number
NCT04231578
Brief Title
Couple HOPES (Helping Overcome PTSD and Enhance Satisfaction)
Acronym
HOPES
Official Title
Couple HOPES: Initial Development of a Guided, Internet-delivered Couple Intervention for Posttraumatic Stress Disorder (PTSD) and Relationship Enhancement
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 31, 2020 (Actual)
Primary Completion Date
January 15, 2023 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Toronto Metropolitan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Posttraumatic stress disorder (PTSD) is a common and disabling condition associated with intimate relationship problems and mental health problems in partners of those with PTSD. Recognizing the need to improve access to evidence-based interventions for those with PTSD and their families, our team has developed an Internet-delivered, self-help intervention to improve PTSD, enhance relationships, and improve partners' mental health: Couple HOPES (Helping Overcome PTSD and Enhance Satisfaction). Couple HOPES presents text and video-based content across seven self-help intervention modules, with modest support from paraprofessional coaches. Although the Couple HOPES platform has been developed, it remains uncertain whether Couple HOPES is feasible, usable, and efficacious in reducing PTSD and enhancing intimate relationship functioning. The proposed project aims to refine and finalize Couple HOPES with couples that include a veteran, service member or first responder with significant PTSD symptoms. This project includes initial testing of the intervention's preliminary efficacy, safety, and feasibility in a series of 10 couples (Phase 1), then in an uncontrolled trial of 20 couples (Phase 2), and then a randomized clinical trial comparing its efficacy to a delayed intervention control condition in 70 couples. Potential benefits of this study include couples learning new skills to reduce PTSD symptoms and enhance relationship functioning, although this is not guaranteed. Risks include participants finding the assessments distressing, or possible worsening of PTSD symptoms or relationship functioning. These risks will be mitigated by continuous monitoring of PTSD symptoms, relationship functioning, and adverse events, and intervention by study staff.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
Self-help, Internet-delivered intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participating couples are either non-randomized in early phases of project or randomized to either immediately receive the Internet-delivered Couple HOPES intervention or to a delayed intervention group, where they receive access to Couple HOPES 8 weeks later.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate Couple HOPES
Arm Type
Experimental
Arm Description
Immediately assigned to receive seven modules of an Internet-delivered self-help intervention with paraprofessional coaching for PTSD completed at the participant's own pace within 8 weeks.
Arm Title
Delayed Intervention
Arm Type
No Intervention
Arm Description
Participants will not receive Couple HOPES for the first 8 weeks, and complete assessments at the beginning, middle, and end of this period. After this 8-week delay, participants will then receive seven modules of an Internet-delivered self-help intervention with paraprofessional coaching for PTSD completed at the participant's own pace within 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Couple HOPES Guided, Internet-Delivered, Self-Help Intervention
Intervention Description
Couple HOPES is a guided self-help intervention for individuals with PTSD and their partners based on Cognitive-Behavioral Conjoint Therapy for PTSD (Monson & Fredman, 2012). This intervention consists of text and video-based content across seven intervention modules and phone and online-based coaching sessions with a paraprofessional. Participants are able to complete these modules in their own home or private location of their choosing. The primary outcomes are PTSD symptoms, relationship satisfaction, and the mental health and wellbeing of partners of those with PTSD.
Primary Outcome Measure Information:
Title
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5) with change measured as mean change from baseline
Description
Scores on the PCL-5 range from 0 to 80, with 80 being the most severe PTSD symptoms.
Time Frame
Baseline, week 3, week 8, approximately once a week during treatment (for up to 8 weeks), after 3 modules are completed or 3 weeks into treatment, after 7 modules are completed or 8 weeks into treatment, 3 month post-treatment follow-up
Title
Couple Satisfaction Index (CSI-4) with change measured as mean change from baseline
Description
Score on the CSI-4 range from 0 to 21, with 21 being the most satisfied.
Time Frame
Baseline, week 3, week 8, approximately once a week during treatment (for up to 8 weeks), after 3 modules are completed or 3 weeks into treatment, after 7 modules are completed or 8 weeks into treatment, 3 month post-treatment follow-up
Secondary Outcome Measure Information:
Title
Mean change from baseline on Ineffective Arguing Inventory
Description
Score range from 0 to 40, with 40 representing highly ineffective arguing.
Time Frame
Baseline, week 3, week 8, after 3 modules are completed or 3 weeks into treatment, after 7 modules are completed or 8 weeks into treatment, 3 month post-treatment follow-up
Other Pre-specified Outcome Measures:
Title
Significant Others' Responses to Trauma Scale with change measured as mean change from baseline
Description
Scores range from 0 to 76, with 76 representing high partner accommodation.
Time Frame
Baseline, week 3, week 8, after 3 modules are completed or 3 weeks into treatment, after 7 modules are completed or 8 weeks into treatment, 3 month post-treatment follow-up
Title
Mean change from baseline on depression as measured by the Patient Health Questionnaire
Description
Scores range from 0 to 27, with 27 being the most depressed.
Time Frame
Baseline, week 3, week 8, after 3 modules are completed or 3 weeks into treatment, after 7 modules are completed or 8 weeks into treatment, 3 month post-treatment follow-up
Title
Mean change from baseline on alcohol use as measured by the Alcohol Use Disorders Identification Test: Self-Report Version
Description
Scores range from 0 to 40, with a higher score signifying an alcohol use disorder.
Time Frame
Baseline, week 3, week 8, after 3 modules are completed or 3 weeks into treatment, after 7 modules are completed or 8 weeks into treatment, 3 month post-treatment follow-up
Title
Mean change from baseline in drug use based on the Drug Abuse Screen Test
Description
Scores range from 0 to 10, with 10 being a severe level of problems related to drug abuse.
Time Frame
Baseline, week 3, week 8, after 3 modules are completed or 3 weeks into treatment, after 7 modules are completed or 8 weeks into treatment, 3 month post-treatment follow-up
Title
Generalized Anxiety Disorder symptoms with change measured as mean change from baseline
Description
Scores range from 0 to 21, with 21 representing the highest level of anxiety.
Time Frame
Baseline, week 3, week 8, after 3 modules are completed or 3 weeks into treatment, after 7 modules are completed or 8 weeks into treatment, 3 month post-treatment follow-up
Title
State-Trait Anger Expression Inventory with change measured as mean change from baseline
Description
Scores range from 0 to 40, with 40 representing higher levels of anger.
Time Frame
Baseline, week 3, week 8, after 3 modules are completed or 3 weeks into treatment, after 7 modules are completed or 8 weeks into treatment, 3 month post-treatment follow-up
Title
Mean change from baseline in perceived health measured with one item "How satisfied are you with your health"
Description
Scores range from 1 to 5, with 5 being the most satisfied.
Time Frame
Baseline, week 3, week 8, after 3 modules are completed or 3 weeks into treatment, after 7 modules are completed or 8 weeks into treatment, 3 month post-treatment follow-up
Title
Trauma-Related Guilt Inventory with change measured as mean change from baseline
Time Frame
Baseline, week 3, week 8, after 3 modules are completed or 3 weeks into treatment, after 7 modules are completed or 8 weeks into treatment, 3 month post-treatment follow-up
Title
Mean change from baseline in work functioning measured with one item "Please rate your ability to function at work. If you do not work outside the home, please rate your ability to complete household tasks."
Time Frame
Baseline, week 3, week 8, after 3 modules are completed or 3 weeks into treatment, after 7 modules are completed or 8 weeks into treatment, 3 month post-treatment follow-up
Title
Mean change from baseline in quality of life measured with one item "How would you rate your quality of life."
Time Frame
Baseline, week 3, week 8, after 3 modules are completed or 3 weeks into treatment, after 7 modules are completed or 8 weeks into treatment, 3 month post-treatment follow-up
Title
Participant ratings of intervention satisfaction as indicated by the Client Satisfaction Questionnaire
Time Frame
After 7 modules are completed or 8 weeks into treatment
Title
Feasibility as measured by number of treatment sessions attended and rate of participant dropout
Time Frame
Once a week during treatment (for up to 8 weeks)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Individual who is a Canadian military member, veteran, or first responder with clinically significant levels of PTSD symptoms Must be willing to be audio-recorded for coaching sessions Intimate partner willing to participant and complete intervention modules together Access to high speed internet Exclusion Criteria: Elevated suicide risk Severe physical aggression between partners in the past year Clinically significant PTSD symptoms in both members of the dyad
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Candice M Monson, PhD
Organizational Affiliation
Toronto Metropolitan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Candice M. Monson
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1Y3
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Monson, C. M., & Fredman, S. J. (2012). Cognitive-behavioral conjoint therapy for PTSD: Harnessing the healing power of relationships. New York, NY: Guilford.
Results Reference
background
PubMed Identifier
35266773
Citation
Monson CM, Wagner AC, Crenshaw AO, Whitfield KM, Newnham CM, Valela R, Varma S, Di Bartolomeo AA, Fulham L, Collins A, Donkin V, Mensah DH, Landy MSH, Samonas C, Morland L, Doss BD, Fitzpatrick S. An uncontrolled trial of couple HOPES: A guided online couple intervention for PTSD and relationship enhancement. J Fam Psychol. 2022 Sep;36(6):1036-1042. doi: 10.1037/fam0000976. Epub 2022 Mar 10.
Results Reference
derived

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Couple HOPES (Helping Overcome PTSD and Enhance Satisfaction)

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