Condition category
Mental and Behavioural Disorders
Date applied
11/10/2017
Date assigned
12/10/2017
Last edited
11/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Anger is a common and normal emotion. However, it can become problematic if it becomes more frequent, more intense, or harder to control. Anger can cause distress and have negative effects on family, friends and jobs. However, there are few widely available treatments for anger available. This study aims to test a self-help internet-based treatment for anger, specifically prepared for armed forces veterans.

Who can participate?
Armed forces veterans from the UK or members of the general population who report elevated levels of anger

What does the study involve?
Participants are randomly allocated to one of two groups: the intervention group and the wait-list group. Participants in the intervention group are given access to the self-help internet-based treatment immediately and can work through the intervention at their own pace, although it is recommended that they complete one module per week. Follow-up questionnaires are completed at 12 weeks and 3 months. Participants in the control group are informed that they will be able to access the trial after a 12-week wait period, with questionnaires again completed at 12 weeks and 3 months. Participants have 12 weeks to complete the intervention with final follow-up at 3 months.

What are the possible benefits and risks of participating?
It is hoped that the internet-delivered CBT self-help will help participants by reducing their symptoms of anger and providing access to the latest techniques to treat anger. A small study using the techniques used in this study found positive results. However, it cannot be guaranteed that this self-help will help. The information from this study may help to improve the treatment of future patients with anger by making self-help more effective and more widely available. If anyone in the study shows signs of worsening symptoms then they are signposted to appropriate help, with their GP contacted in the event that risk is reported. Being part of this study will involve participants giving their time to complete the questionnaires and the exercises included in the program on multiple occasions. Some of the questions are personal and sometimes people can find it upsetting to report on these issues, but they do not have to provide answers if they do not want to. Most people find that any upset or distress is short-lived and on a par with events that typically happen in daily life. It is possible that the internet self-help will not work. If this is the case, then participants can still talk to their GP about other options that may be offered in their area. There are no other known side effects, disadvantages, or risks of taking part in this study or receiving internet-delivered CBT.

Where is the study run from?
University of Exeter (UK)

When is the study starting and how long is it expected to run for?
September 2017 to May 2018

Who is funding the study?
1. University of Exeter (UK)
2. Help for Heroes (UK)

Who is the main contact?
Luke O'Shea
l.oshea@exeter.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Mr Luke O'Shea

ORCID ID

Contact details

Sir Henry Wellcome Building for Mood Disorders Research
University of Exeter
Perry Road
Exeter
EX4 4QG
United Kingdom
+44 (0)1392 726449
l.oshea@exeter.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Anger RCT 1.1

Study information

Scientific title

Developing and evaluating an internet-based self-help intervention for anger in armed forces veterans: a randomised controlled feasibility trial

Acronym

Study hypothesis

The primary aim of this randomised controlled trial will be to test the feasibility of an internet-based unguided self-help intervention for anger in armed forces veterans (and as necessary community individuals) reporting elevated anger issues compared to a wait list control (WLC). The areas to be addressed will include the acceptability of an internet intervention for anger in this population, the recruitment and retention rate, and estimates of incident rate and effect size. The goal is to work towards a definitive randomised controlled trial to provide strong causal inference of the effect size of the intervention: as such, the feasibility study will use the same design and will provide a proof-of-principle test of the value of this approach. The wait list control will be given access to the intervention after twelve weeks.

Ethics approval

CLES Psychology Ethics Committee, 06/10/2017, ref: eCLESPsy000034 v4.1

Study design

Single-centre single-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Internet

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Anger

Intervention

Participants will be randomised via stratified block randomisation. Following screening participants identified as eligible to take part in the study will be randomised to one of two groups: the intervention group and wait-list group. Participants in the intervention group will be given access to the intervention immediately and can work through the intervention at their own pace, although it is recommended that they complete one module per week. Follow-up measures will be administered at 12 weeks and 3 months. Participants in the control group will be informed that they will be able to access the trial after a 12 week wait period, with measures again completed at 12 weeks and 3 months. Participants will have 12 weeks to complete the intervention with final follow-up at 3 months.

The internet intervention is based on a novel anger-as-a-habit intervention that is being trialled by the Hidden Wounds service at Help for Heroes. The intervention posits that anger is a result of habitual behaviour and that changing habits might be beneficial for individuals experiencing anger (Gentry, Chesney, Kennedy, Hall, Gary Jn & Harburg, 1983). It builds on the principle that a habit is formed through 3 key factors; the behaviour is repeated, it is an automatic response and that it is cued by stable contexts, and that through this repetition a habit is formed and reinforced (Orbell & Verplanken, 2010). The intervention encourages participants to break into the habit cycle through the use of implementation interventions to replace the existing angry response to a situation with an alternate response that stops the reinforcement of their anger.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

The feasibility and acceptability of data collection procedures, levels of attrition, effect size and the acceptability of the unguided anger intervention will be measured to aid planning for a fully powered, definitive, phase III trial:
1. The feasibility of data collection procedures is assessed by measuring the missing items on the clinical outcome measures, the number and timing of drop-outs and whether these vary across arms
2. The acceptability of the intervention is assessed using a behavioural index measuring the number of modules completed, the time spent logged into the site and which modules are completed more easily or frequently than others

Secondary outcome measures

1. Depression, measured using PHQ-9 at baseline, final module, 12 weeks and 3 months follow-up
2. Anger, measured using NAS-PI at baseline, final module, 12 weeks and 3 months follow-up
3. PTSD symptomatology, measured using PCL at baseline, 12 weeks and 3 months follow-up
4. Anger, measured using DAR in each intervention module and final module

Overall trial start date

01/09/2017

Overall trial end date

31/05/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Armed forces veterans from the UK or members of the general population who report elevated levels of anger represented by a score of ≥75 on the NAS-PI provocation subscale (Novaco, 2003). This measure has been selected as it identifies individuals experiencing levels of anger that are higher than those experienced in a general population which is indicative of problematic anger
2. Aged 18+
3. Individuals who have accessed the Help for Heroes Hidden Wounds service or community based advertising and who screen as eligible for inclusion in the study
4. Participants will primarily be armed forces veterans as described under the British definition of a veteran ‘Those who have served for at least one day in HM Armed Forces, whether as a regular or reservist’ (Ministry of Defence, 2013). With members of the general public recruited as necessary to meet recruitment targets as long as they meet the other eligibility criteria
5. In addition to this the participants must be able to understand written English and have access to a private internet connection to ensure they are able to give informed consent, engage with the intervention and ensure their confidentiality when engaging with the intervention

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

Participants will be excluded from the study if:
1. They are actively serving members of the armed forces
2. Under the age of 18
3. They report elevated symptoms of post-traumatic stress disorder on the Posttraumatic Stress Disorder checklist (PCL; Weathers, Litz, Keane, Palmieri, Marx, Schnurr, 2013) indicated by a score of ≥50 (the recommended cut off score)
4. They report suicidal ideation measured using the PHQ-9 (Kroenke, Spitzer & Williams, 2001) question 9 and risk protocol follow up questions
5. They report moderately severe levels of depression on the PHQ-9 (Kroenke, Spitzer & Williams, 2001)

Recruitment start date

01/10/2017

Recruitment end date

31/03/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Exeter
Sir Henry Wellcome Building for Mood Disorders Research University of Exeter Perry Road
EX4 4QG
United Kingdom

Sponsor information

Organisation

University of Exeter

Sponsor details

University of Exeter Reception
Stocker Road
Exeter
EX4 4PY
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of Exeter

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Funder name

Help for Heroes

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. A trial protocol paper is being compiled with the intention to publish this in an academic journal making it widely available. The data analysis intentions will be included in this.
2. The RCT will form part of Luke O'Shea's PhD thesis with the intention to also publish it in a peer reviewed academic journal.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/05/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes