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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05013398
Other study ID # EGR17Q4\100016
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 7, 2019
Est. completion date September 26, 2019

Study information

Verified date August 2021
Source Combat Stress
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Evidence has found that living alongside a veteran suffering from mental health difficulties can have an adverse outcome on relationships and the health of family members. Military partners, in particular, have been highlighted as a high-risk group for developing mental health difficulties due to their close relationship with the veteran, exposure to adverse details of the veteran's military experiences and, in some cases, need to take on a caregiving role. Investigation of the impact on military partners suggests that they are an increased risk of depression, anxiety, alcohol use difficulties, as well as symptoms of secondary traumatization. Despite an interest and need for mental health support among military partners, many face a range of barriers that prevent accessing and engaging in support. Such barriers include stigma around help seeking behaviors, difficulties in travelling to support venues, and work or childcare responsibilities that may limit their availability to engage with support. As such, there remains a need to make mental health support for military partners more accessible. The Together Webinar Programme (TTP-Webinar) is a six-week online intervention developed to increase the accessibility of mental health support for military partners. TTP-Webinar was adapted from a five-week community-based TTP programme that was piloted across nine UK locations. Despite the community-based TTP programme demonstrating promising effects on mental health difficulties among military partners, the pilot revealed that many partners were unable to engage with support because of issues traveling to and from community centres around balancing other commitments. The present study was a pilot randomized controlled trial (RCT) aimed at investigating the utility of TTP-Webinar as an online intervention to increase the accessibility of support. 60 partners of veterans with PTSD and other mental health difficulties were randomised to either the TTP-Webinar intervention (n = 30) or waitlist condition (n = 30). Measures of general psychological distress, secondary trauma symptoms and quality of life were administered at baseline, end of treatment, and one-month follow-up.


Recruitment information / eligibility

Status Completed
Enrollment 196
Est. completion date September 26, 2019
Est. primary completion date September 26, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Be over the age of 18 - Live in the UK - Currently be in relationship with a veteran - Provide written consent Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
The Together Webinar Programme
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).

Locations

Country Name City State
United Kingdom Combat Stress Leatherhead Surrey

Sponsors (2)

Lead Sponsor Collaborator
Combat Stress Royal British Legion

Country where clinical trial is conducted

United Kingdom, 

References & Publications (6)

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). pii: E68. doi: 10.3390/jcm5080068. — View Citation

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.

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. — View Citation

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. Epub 2009 Feb 10. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
Primary 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.
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