A comparison of emotion-focused therapy and cognitive-behavioural therapy in the treatment of generalised anxiety disorder
| ISRCTN | ISRCTN52689081 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52689081 |
| Secondary identifying numbers | HRA-POR-2015-1052 |
- Submission date
- 24/10/2017
- Registration date
- 01/11/2017
- Last edited
- 04/02/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Generalised Anxiety Disorder (GAD) is a disorder in which the sufferer feels in a constant state of high anxiety. The aim of this study is to compare the effectiveness of two different therapies for Generalised Anxiety Disorder (GAD). Cognitive Behavioural Therapy (or CBT) is an established approach, while Emotion-Focused Therapy (or EFT) is a new approach for GAD, recently developed. It is believed that both therapies will be helpful. However, by studying how the two therapies compare, this study aims to improve the options available.
Who can participate?
Patients aged 18 and older with GAD
What does the study involve?
Participants are randomly allocated to either the EFT or CBT therapy. Therapy lasts between 16 and 20 weeks. Participants are also asked to meet with the research team at the end of therapy and 6 months after therapy ends in order to complete assessment forms. In addition, sessions are recorded in order that a random selection of sessions can be reviewed to ensure that the therapist is delivering the therapy as expected.
What are the possible benefits and risks of participating?
There are a number of possible risks and benefits for participants. As with any psychological therapy, there is no guarantee that therapy will be helpful for everyone, and research has shown that a small number of people get worse while in therapy. Although early results for EFT are promising, it is still a new treatment for anxiety, and while CBT has been shown to be effective, it is not always so. While every care will be taken to ensure confidentiality will be respected and that data will be stored securely, there is a degree of risk involved in the transfer and storage of confidential data. In addition, though not a risk per se, attending the additional assessment meetings with the research team is an extra time commitment and participants may have some anxiety about the fact that sessions are being recorded. Regarding benefits, participants will be offered therapy that will be closely supervised by experts in that particular therapy, and for a duration that is more than twice as long as is normally provided by CIPC. It is hoped therefore that participation in either intervention will be more beneficial than routine care provided.
Where is the study run from?
The study is being conducted by researchers from the School of Psychology in Trinity College Dublin in conjunction with the HSE’s Counselling in Primary Care service
When is the study starting and how long is it expected to run for?
December 2016 to December 2019
Who is funding the study?
Health Research Board (Ireland)
Who is the main contact?
Dr Ladislav Timulak
Contact information
Scientific
School of Psychology
Trinity College Dublin
Dublin
2
Ireland
 ORCID ID |
0000-0003-2785-0753 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A comparison of emotion-focused therapy and cognitive-behavioural therapy in the treatment of generalised anxiety disorder: a randomised controlled trial |
| Study hypothesis | The overall aim of the project is to contribute to the planning of a definitive, non-inferiority trial that would establish the relative efficacy of Emotion-Focused Therapy (EFT) in comparison to Cognitive Behavioural Therapy (CBT) as a treatment for Generalised Anxiety Disorder (GAD). The current project will provide first comparison data that, if suggesting comparable or better outcomes for the experimental intervention, should help to plan a definitive non-inferiority trial. It will test recruitment, adherence, and acceptability/retention rates, as well as providing estimates of comparative outcomes, that can be used to inform power calculations for a definitive, non-inferiority trial. |
| Ethics approval(s) | 1. Health Service Executive North East Area Research Ethics Committee (REC), 12/07/2017 2. The School of Psychology Research Ethics Committee, Trinity College Dublin, Dublin, Ireland, 19/10/2017 |
| Condition | Generalised anxiety disorder (and some potential co-morbid symptoms/conditions) |
| Intervention | Participants will be randomly allocated to one of two active parallel interventions: an experimental intervention (Emotion-Focused Therapy for GAD; EFT for GAD), and a well-established benchmark comparison (Cognitive Behavioural Therapy; CBT for GAD). Participants will be randomly assigned to either EFT or CBT intervention with a 1:1 allocation, nested within therapists, as per a computer generated randomisation schedule (online randomiser: https://www.random.org/lists/). 1. The EFT for GAD intervention is based on the protocol developed by Timulak and McElvaney (2015) 2. The CBT for GAD protocol used will be based on the model developed by Dugas and Robichaud (2007) based on their theory of the role of intolerance of uncertainty in GAD Both interventions will be up to 16 sessions in duration. Therapy will last between 16 and 20 weeks. Participants will also be asked to meet with the research team at the end of therapy and 6 months after therapy ends in order to complete assessment forms. In addition, sessions will be recorded in order that a random selection of sessions can be reviewed to ensure that the therapist is delivering the therapy as expected. |
| Intervention type | Behavioural |
| Primary outcome measure | Severity of Generalised Anxiety Disorder symptoms, assessed using the GAD-7 questionnaire (Spitzer, Kroenke, Williams and Löwe, 2006) at pre-treatment, post-treatment, and at 6 month follow-up |
| Secondary outcome measures | (1) The Clinical Outcome in Routine Evaluation – Outcome Measure (CORE-OM; Evans et al., 2000); (2) The Generalised Anxiety Disorder Severity Scale (GADSS; Shear, Belnap, Mazumdar, Houck and Rollman, 2006); and (3) The Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001). (4) In addition, a subset of items (e.g. questions 10 - 17) from the Counselling in Primary Care (CIPC) Client Satisfaction Survey, which is routinely administered to all CIPC clients at end of therapy, will be analysed. 1. Psychological distress across four domains (subjective well-being, problems or symptoms, life functioning and risk), measured using the Clinical Outcome in Routine Evaluation – Outcome Measure (CORE-OM; Evans et al., 2000) at pre-treatment, post-treatment, and at 6 month follow-up 2. GAD specific symptom severity, measured using the Generalised Anxiety Disorder Severity Scale (GADSS; Shear, Belnap, Mazumdar, Houck and Rollman, 2006) at pre-treatment, post-treatment, and at 6 month follow-up 3. Severity of depression symptoms, assessed using the Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001) at pre-treatment, post-treatment, and at 6 month follow-up 4. Client satisfaction with various aspects of therapy and service delivery, measured using a subset of items (e.g. questions 10 - 17) from the Counselling in Primary Care (CIPC) Client Satisfaction Survey at end of therapy |
| Overall study start date | 12/12/2016 |
| Overall study end date | 20/10/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 70 |
| Total final enrolment | 59 |
| Participant inclusion criteria | 1. Participants will be recruited from medical card holding, adult (18 years and older) clients, referred by their GP to the HSE Counselling in Primary Care (CIPC) service (a service offered by the Irish public health service provider) 2. Participants must meet criteria for a primary diagnosis of Generalised Anxiety Disorder on the Structured Clinical Interview for DSM-V 3. Participants must agree to be part of the study and consent to study conditions (including giving consent for sessions to be recorded and agreeing to attend appointments for follow up assessments) 4. Clients on medication will be allowed to enter the study provided that their medication has been stabilised for at least 6 weeks |
| Participant exclusion criteria | 1. Concurrent treatment 2. Suicide risk, or risk of harm to others (as indicated by items on the CORE-OM) 3. Substance abuse 4. Psychosis 5. Organic brain syndrome |
| Recruitment start date | 08/12/2017 |
| Recruitment end date | 20/12/2019 |
Locations
Countries of recruitment
- Ireland
Study participating centre
Navan
C15 VP66
Ireland
Sponsor information
Hospital/treatment centre
34 Brews Hill, Navan, Co. Meath
Navan
C15 VP66
Ireland
"ROR" |
https://ror.org/04zke5364 |
|---|
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Health Research Board, Ireland, An Bord Taighde Sláinte, HRB
- Location
- Ireland
Results and Publications
| Intention to publish date | 01/08/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | It is anticipated that the following publications, published in an open access format in high-impact peer reviewed journals, will be realised from the trial: 1. Publication of the trial protocol 2. Publication of the main outcomes results 3. One or two publications of the qualitative outcomes and clients perspectives |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Ladislav Timulak. Coded participant level data will be stored for 10 years in keeping with Trinity College Dublin research data management policy. Once results have been published, relevant data and materials can be made available on request to other researchers, in keeping with the funder’s, Health Research Board, policy. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 19/09/2018 | Yes | No | |
| Results article | 03/02/2022 | 04/02/2022 | Yes | No |
Editorial Notes
04/02/2022: Publication reference added.
21/07/2021: The intention to publish date was changed from 01/07/2021 to 01/08/2021.
15/06/2021: The intention to publish date was changed from 20/12/2020 to 01/07/2021.
08/01/2020: The total final enrolment number has been added.
06/12/2019: The following changes have been made:
1. The recruitment end date has been changed from 30/11/2019 to 20/12/2019.
2. The overall trial end date has been changed from 11/12/2019 to 20/10/2020.
3. The intention to publish date has been changed from 11/12/2020 to 20/12/2020.
21/09/2018: Publication reference added.
19/02/2018: The recruitment start date was changed from 30/10/2017 to 08/12/2017.
