Assessing the efficacy of emotion-focused therapy in the treatment of depression, anxiety and related disorders
| ISRCTN | ISRCTN11430110 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11430110 |
| Protocol serial number | SPREC102018-18 |
| Sponsors | Trinity College Dublin, Institute of Emotion-Focused Therapy, Ireland |
| Funder | Investigator initiated and funded |
- Submission date
- 02/01/2019
- Registration date
- 07/01/2019
- Last edited
- 14/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Over the last few decades, a widespread practice in psychotherapy and counselling research has been to develop specific psychotherapeutic treatments for specific psychological problems. So for example different versions of Cognitive Behaviour Therapy (CBT) have been developed for depression and for social anxiety. However, research has shown that individuals with mental health difficulties often struggle with more than one psychological problem at the same time (e.g., a patient might suffer from both depression and social anxiety). Research also indicates that while these different problems may look different, they often share common causes and can be maintained by common processes. For these reasons, a recent development in psychotherapy research has been to develop what are called 'transdiagnostic' interventions, whereby the same intervention can be used to treat patients presenting with a range of different problems and/or patients struggling with more than one problem. To date most transdiagnostic interventions are adaptations of CBT. However not all patients benefit from or prefer CBT, and so there is an argument that patient well-being can be improved by increasing the range or choice of evidence-based interventions available. Emotion-focused Therapy (EFT) is an evidence-based intervention that has been shown to be effective for a range of psychological problems. The current study seeks to adapt EFT as a transdiagnostic treatment for depression, anxiety and a number of related disorders. It also seeks to test the effectiveness of the adapted model by comparing the outcomes (that is, the extent to which participants experience a change in their symptoms) for 20 patients treated with EFT in a community-based couselling service with the outcomes for 20 patients placed on a waiting list. Waiting list patients will get therapy at a later point. Video- recordings of therapy and interviews with participants will be studied in order to further develop the model.
Who can participate?
Individuals who are 18 years or older. Individuals who meet criteria for one or more of the following conditions; depression (major depressive disorder or persistent depressive disorder), anxiety (social anxiety, generalised anxiety, specific phobia, agoraphobia, panic disorder), obsessive-compulsive disorder (i.e., OCD) or a trauma related disorder (including Post Traumatic Stress Disorder).
What does the study involve?
Participants will be allocated randomly to one of two conditions: either (1) active condition – approx. 16 sessions of emotion-focused therapy, or (2) waitlist/delayed intervention. Participants allocated to the waitlist condition will be given an appointment to begin therapy in 16 weeks.
What are the possible benefits and risks of participating?
Participants will be offered psychotherapy already established as a treatment of depression and potentially anxiety by certified EFT therapists and/or psychologists who are closely supervised by an expert in EFT. Therapy will be provided free of charge.
As with any psychological therapy, not everyone may find therapy helpful, and a small number of people may get worse while in therapy. The research procedure may be time consuming, and the therapy or research procedure may stir difficult emotions. You will also be randomly allocated to either therapy or waitlist/delayed intervention and if allocated to the waitlist condition will have to wait 16 weeks before therapy begins. We will attend to these risks by endeavouring to be respectful and supportive at all times through the process.
Where is the study run from?
The premises of the Institute of Emotion-Focused Therapy Ireland.
When is the study starting and how long it is expected to run for?
September 2018 to June 2025
Who is funding the study?
This study is being conducted by researchers at the School of Psychology in Trinity College Dublin in conjunction with the Institute of Emotion-Focused Therapy Ireland.
Who is the main contact?
Dr. Ladislav Timulak timulakl@tcd.ie
Contact information
Scientific
School of Psychology
Trinity College Dublin
Dublin
2
United Kingdom
 ORCID ID |
0000-0003-2785-0753 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional, randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | ISRCTN11430110_PIS_3Jan19.docx |
| Scientific title | Emotion-Focused Therapy as a Transdiagnostic treatment for depression and anxiety and related disorders: An initial randomised control trial. |
| Study acronym | EFT-T |
| Study objectives | EFT-T will be more effective than wait-list control. |
| Ethics approval(s) | Trinity College Dublin's School of Psychology Research Ethics Committee, 14/12/2018, ref. SPREC102018-18. |
| Health condition(s) or problem(s) studied | Depression and anxiety and related disorders (such as obsessive-compulsive disorders and trauma/stressor related disorders). |
| Intervention | Current intervention as of 11/07/2022: Emotion-Focused Therapy – Transdiagnostic (EFT-T) The EFT-T intervention will follow a recently developed model (Timulak, 2015; Timulak & Keogh, 2018) integrating EFT adaptations for various disorders (e.g., Elliott & Shahar, 2017; Greenberg & Watson, 2006; Paivio & Pascual-Leone, 2010; Timulak & McElvaney, 2017; Watson & Greenberg, 2017) using a unique transdiagnostic framework. The transdiagnostic model, conceptually based on a model of emotional transformation processes in psychotherapy (see Timulak, 2015 and Timulak & McElvaney, 2017), uses (1) elements of a modular approach targeting symptom level presentations (i.e., with some interventions used in the context of certain primary diagnoses/presentations) and (2) an underlying emotional vulnerability approach that targets the chronic painful (feared) emotions of sadness/loneliness, shame, and fear/terror present in depression, anxiety and related disorders. The EFT-T model uses a specific case conceptualisation which postulates that symptoms of depression and anxiety signal difficulty (e.g., dysregulation/avoidance) in processing specific chronic painful feelings (e.g., sadness/loneliness, shame, and primary fear/terror) triggered in the client’s interaction with the environment. Therapy will last 16 to 20 sessions. Therapists will be instructed to finish therapy at session 16, but will have flexibility based on their clinical judgement to extend therapy to a maximum of 20 sessions. The design of the study is a randomised controlled trial (RCT) with two groups (EFT and wait-list with an ensuing delayed intervention-EFT). Clients (n=40) will be randomized to two groups. Participants will be recruited via GP referral and the trial will be promoted by an advertisement on the hosting clinic’s website. Participants will then be seen in a private clinic offering psychological therapy to people with depression, anxiety and related disorders. Waitlist group will undergo the same therapy 16 weeks after they are put on the waitlist. Where continuing Covid-19-related restrictions mean that pre-therapy and post-therapy assessments cannot be conducted in person (or if the restrictions are eased but the participant/researcher prefers not to meet in person), these assessments are conducted via phone, and/or via secure Zoom. Where continuing Covid-19-related restrictions mean that therapy cannot be conducted in person (or if the restrictions are eased but the client/therapist prefers not to meet in person), therapy is provided through secure Zoom. _____ Previous intervention: Emotion-Focused Therapy – Transdiagnostic (EFT-T) The EFT-T intervention will follow a recently developed model (Timulak, 2015; Timulak & Keogh, 2018) integrating EFT adaptations for various disorders (e.g., Elliott & Shahar, 2017; Greenberg & Watson, 2006; Paivio & Pascual-Leone, 2010; Timulak & McElvaney, 2017; Watson & Greenberg, 2017) using a unique transdiagnostic framework. The transdiagnostic model, conceptually based on a model of emotional transformation processes in psychotherapy (see Timulak, 2015 and Timulak & McElvaney, 2017), uses (1) elements of a modular approach targeting symptom level presentations (i.e., with some interventions used in the context of certain primary diagnoses/presentations) and (2) an underlying emotional vulnerability approach that targets the chronic painful (feared) emotions of sadness/loneliness, shame, and fear/terror present in depression, anxiety and related disorders. The EFT-T model uses a specific case conceptualisation which postulates that symptoms of depression and anxiety signal difficulty (e.g., dysregulation/avoidance) in processing specific chronic painful feelings (e.g., sadness/loneliness, shame, and primary fear/terror) triggered in the client’s interaction with the environment. Therapy will last 16 to 20 sessions. Therapists will be instructed to finish therapy at session 16, but will have flexibility based on their clinical judgement to extend therapy to a maximum of 20 sessions. The design of the study is a randomised controlled trial (RCT) with two groups (EFT and wait-list with an ensuing delayed intervention-EFT). Clients (n=40) will be randomized to two groups. Participants will be recruited via GP referral and the trial will be promoted by an advertisement on the hosting clinic’s website. Participants will then be seen in a private clinic offering psychological therapy to people with depression, anxiety and related disorders. Waitlist group will undergo the same therapy 16 weeks after they are put on the waitlist. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
To be measured at pre-therapy, post therapy (16 weeks; but also post last session in cases where the last session falls outside the range of 16 ± 2 weeks) and at 6-month follow up: |
| Key secondary outcome measure(s) |
1. Each participant will also be asked to complete at pre-therapy, post therapy (16 weeks; but also post last session in cases where the last session falls outside the range of 16 ± 2 weeks) and at 6-month follow up, at least one of the following disorder specific measures, as determined by the principal diagnosis assessed at pre-therapy. |
| Completion date | 30/06/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion criteria | 1. Meet the criteria for depression, an anxiety disorder and/or related disorder (obsessive-compulsive disorders and trauma/stressor related disorders) as a principal diagnosis. 2. If taking psychotropic medication then must be stabilised on that medication for 6 weeks prior to commencing therapy. 2.1. Shows, with their physician’s approval, a willingness to maintain this stability in medication use during the period of therapy |
| Key exclusion criteria | 1. Concurrent psychological treatment 2. Suicide risk 3. Risk of harm to others 4. Substance abuse 5. Psychosis 6. Organic brain syndrome |
| Date of first enrolment | 01/02/2019 |
| Date of final enrolment | 31/12/2023 |
Locations
Countries of recruitment
- United Kingdom
- Ireland
Study participating centre
Dublin
2
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 13/02/2020 | 11/07/2022 | Yes | No | |
| Participant information sheet | 03/01/2019 | 07/01/2019 | No | Yes | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN11430110_PIS_3Jan19.docx
- Uploaded 07/01/2019
Editorial Notes
14/06/2024: The following changes were made:
1. The overall study end date was changed from 30/06/2024 to 30/06/2025.
2. The intention to publish date was changed from 31/08/2024 to 30/10/2025.
01/11/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 28/02/2022 to 31/12/2023.
2. The overall end date was changed from 31/12/2023 to 30/06/2024.
3. The plain English summary was updated to reflect these changes.
11/07/2022: The following changes have been made:
1. The recruitment end date has been changed from 31/08/2021 to 28/02/2022.
2. The overall trial end date has been changed from 31/01/2022 to 31/12/2023 and the plain English summary updated accordingly.
3. The intention to publish date has been changed from 31/08/2022 to 31/08/2024.
4. Publication reference added.
5. The intervention has been changed.
6. Recruitment had been resumed.
05/05/2020: Due to current public health guidance, recruitment for this study has been paused.
24/04/2019: Internal review.
07/01/2019: The participant information sheet has been uploaded as an additional file.
