Psychological DistressTTP-WebinarNCT05013398
The Together Webinar Programme For Military Partners
A study testing The Together Webinar Programme in people with Psychological Distress, run by Combat Stress at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress
- What is being tested?
- The Together Webinar Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 May 2019to 26 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be over the age of 18
- Live in the UK
- Currently be in relationship with a veteran
- Provide written consent
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Supporting the Mental Health Needs of Military Partners Through The Together Webinar Programme: Pilot Randomized Controlled Trial
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.
Read the detailed 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.
- Conditions
- Psychological Distress
- Being tested
- The Together Webinar Programme
- Keywords
- Military partners, Mental Health Support, Online group-based support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Together Webinar ProgrammeBehavioural
Also called TTP-Webinar
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).
| Study group | Role | What they receive |
|---|---|---|
| The Together Webinar Programme (TTP-Webinar) | Experimental | Participants receive the six weekly session TTP-Webinar intervention. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, end of treatment (6 weeks), and one-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start7 May 2019
- Primary completion26 Sep 2019
- Study completion26 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Combat Stress
- Sponsor type
- University, hospital or other
- Collaborators
- Royal British Legion
- Responsible party
- Principal investigator, Prof. Dominic Murphy, Combat Stress
- Investigators
- Dominic Murphy, Principal investigator, Combat Stress
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05013398
- Sponsor's protocol ID
- EGR17Q4\100016
- Acronym
- TTP-Webinar
- Status last verified
- Aug 2021
- First submitted
- 29 Jul 2021
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27909070Yambo 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.
PubMed 24441511Ray 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.
PubMed 19201406Sayers 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.
PubMed 19210950Murphy 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.
PubMed 27490576Murphy 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.
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.
PubMed 34636734
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting the Mental Health Needs of Military Partners Through The Together Webinar Programme: Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05013398
- Acronym / sponsor ID
- TTP-Webinar / EGR17Q4\100016
- Conditions
- Psychological Distress
- Keywords
- Military partners, Mental Health Support, Online group-based support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Combat StressUniversity, hospital or other
- Collaborators
- Royal British Legion
- Study start
- 7 May 2019 (actual)
- Primary completion
- 26 Sep 2019 (actual)
- Study completion
- 26 Sep 2019 (actual)
- First posted
- 19 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Together Webinar Programme (TTP-Webinar) | Experimental | Behavioral: The Together Webinar ProgrammeParticipants receive the six weekly session TTP-Webinar intervention. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be over the age of 18
- Live in the UK
- Currently be in relationship with a veteran
- Provide written consent
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Together Webinar ProgrammeAlso: TTP-WebinarThe 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). | Behavioural | The Together Webinar Programme (TTP-Webinar) |
Primary outcome
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
Time frame: Baseline, end of treatment (6 weeks), and one-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.
Change in symptoms of secondary traumatization on the Secondary Traumatic Stress Scale (STSS) from baseline to end of treatment to 1-month follow-up
Time frame: Baseline, end of treatment (6 weeks), and one-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.
Change in Quality of life (QoL) from baseline to end of treatment to 1-month follow-up.
Time frame: Baseline, end of treatment (6 weeks), and one-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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- Background: PubMed 27909070Thandi 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.
- Background: PubMed 24441511Yambo 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.
- Background: PubMed 19201406Ray 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.
- Background: PubMed 19210950Sayers 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.
- Background: PubMed 27490576Murphy 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.
- BackgroundMurphy 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.
- Derived from this study: PubMed 34636734Hendrikx 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominic Murphy principal investigator
Combat Stress
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Together Webinar Programme in people with Psychological Distress, run by Combat Stress at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline, end of treatment (6 weeks), and one-month follow-up.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05013398, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021.