NCT05013398

Brief Summary

Military partners are at risk of mental health difficulties, including depression, anxiety and secondary traumatization. However, many partners face a range of barriers in accessing psychological support. As such, there remains a need to investigate how to make support for military partners more accessible. The present study was a pilot randomized controlled trial (RCT) investigating the effectiveness of The Together Webinar Programme (TTP-Webinar) in reducing psychological distress and secondary trauma symptoms and improving quality of life among partners of veterans with PTSD and other mental health difficulties. The pilot RCT compared the TTP-Webinar intervention to a waitlist condition. The primary aim was to assess the acceptability and feasibility of offering web-based support to military partners and to investigate the efficacy of the remote-access support. It was hypothesized that, compared to the waitlist condition, the TTP-Webinar would result in significant reductions in psychological distress and secondary symptoms, and improvements in overall quality of life.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 7, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2019

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 19, 2021

Completed
Last Updated

August 19, 2021

Status Verified

August 1, 2021

Enrollment Period

5 months

First QC Date

July 29, 2021

Last Update Submit

August 18, 2021

Conditions

Keywords

Military partnersMental Health SupportOnline group-based support

Outcome Measures

Primary Outcomes (3)

  • Change in symptoms of the psychological distress on the General Health Questionnaire (GHQ-12) from baseline to end of treatment to 1-month follow-up

    The GHQ-12 (Goldberg \& Williams, 1988) is 12-item measure of symptoms of general psychological distress. Items are scoring using a 5-point Likert scale ranging from 0 ('Not at all'/'Much less than usual') to 4 ('Much more than usual'/'More so than usual'), indicating how much they have been bothered by symptoms within the past month. Six positive items are reverse scored, before calculating a total score with larger scores indicating greater psychological distress.

    Baseline, end of treatment (6 weeks), and one-month follow-up.

  • Change in symptoms of secondary traumatization on the Secondary Traumatic Stress Scale (STSS) from baseline to end of treatment to 1-month follow-up

    The STSS (Bride et al., 2004) is a 17-item measure assessing symptoms of secondary traumatization. Items are scored on a 5-point Likert scale ranging from 0 ('Never') to 5 ('Very often'), indicating how much they have been bothered by symptoms within the past month. Total scores are created per subscales (avoidance, arousal, and intrusions) and across all subscales, with larger scores indicating greater secondary trauma symptoms.

    Baseline, end of treatment (6 weeks), and one-month follow-up.

  • Change in Quality of life (QoL) from baseline to end of treatment to 1-month follow-up.

    QoL was assessed with a single item, using a scale ranging from 1 ('Very good') to 5 ('Very bad'). Scores were reverse scored, for larger scores to reflect greater quality of life.

    Baseline, end of treatment (6 weeks), and one-month follow-up.

Study Arms (2)

The Together Webinar Programme (TTP-Webinar)

EXPERIMENTAL

Participants receive the six weekly session TTP-Webinar intervention.

Behavioral: The Together Webinar Programme

Waitlist condition

NO INTERVENTION

Participants do not receive any intervention as part of waitlist condition. Note: Following the collection of measures at the follow-up time point, participants assigned to the waitlist condition were offered four TTP-Webinar groups to sign up to.

Interventions

The TTP-Webinar consists of six hour-long sessions. Each session focuses on psychoeducation and self-management strategies for supporting veteran mental health difficulties as well as self-management tools to enhance partners' own wellbeing. The TTP-Webinar treatment protocol incorporates a range of techniques used in Cognitive Behavioral Therapy (CBT), Dialectical Behavioral Therapy (DBT), Compassion Focused Therapy (CFT), and Acceptance and Commitment Therapy (ACT).

Also known as: TTP-Webinar
The Together Webinar Programme (TTP-Webinar)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be over the age of 18
  • Live in the UK
  • Currently be in relationship with a veteran
  • Provide written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Combat Stress

Leatherhead, Surrey, KT22 0BX, United Kingdom

Location

Related Publications (7)

  • Thandi G, Oram S, Verey A, Greenberg N, Fear NT. Informal caregiving and intimate relationships: the experiences of spouses of UK military personnel. J R Army Med Corps. 2017 Aug;163(4):266-272. doi: 10.1136/jramc-2016-000679. Epub 2016 Dec 1.

    PMID: 27909070BACKGROUND
  • Yambo T, Johnson M. An integrative review of the mental health of partners of veterans with combat-related posttraumatic stress disorder. J Am Psychiatr Nurses Assoc. 2014 Jan-Feb;20(1):31-41. doi: 10.1177/1078390313516998. Epub 2014 Jan 17.

    PMID: 24441511BACKGROUND
  • Ray SL, Vanstone M. The impact of PTSD on veterans' family relationships: an interpretative phenomenological inquiry. Int J Nurs Stud. 2009 Jun;46(6):838-47. doi: 10.1016/j.ijnurstu.2009.01.002. Epub 2009 Feb 7.

    PMID: 19201406BACKGROUND
  • Sayers SL, Farrow VA, Ross J, Oslin DW. Family problems among recently returned military veterans referred for a mental health evaluation. J Clin Psychiatry. 2009 Feb;70(2):163-70. doi: 10.4088/jcp.07m03863. Epub 2009 Feb 10.

    PMID: 19210950BACKGROUND
  • Murphy D, Palmer E, Busuttil W. Mental Health Difficulties and Help-Seeking Beliefs within a Sample of Female Partners of UK Veterans Diagnosed with Post-Traumatic Stress Disorder. J Clin Med. 2016 Aug 1;5(8):68. doi: 10.3390/jcm5080068.

    PMID: 27490576BACKGROUND
  • Murphy D, Spencer-Harper L, Turgoose D. Exploring the feasibility of supporting UK partners living alongside veterans with PTSD: A pilot study of the Together Programme (TTP). Journal of Family Medicine. 2019; 1(2): 30-41.

    BACKGROUND
  • Hendrikx LJ, Murphy D. Supporting the Mental Health Needs of Military Partners Through the Together Webinar Program: Pilot Randomized Controlled Trial. JMIR Ment Health. 2021 Oct 12;8(10):e25622. doi: 10.2196/25622.

Study Officials

  • Dominic Murphy

    Combat Stress

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of research department

Study Record Dates

First Submitted

July 29, 2021

First Posted

August 19, 2021

Study Start

May 7, 2019

Primary Completion

September 26, 2019

Study Completion

September 26, 2019

Last Updated

August 19, 2021

Record last verified: 2021-08

Locations