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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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21 February 2022 |
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Main ID: |
ISRCTN52689081 |
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Date of registration:
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01/11/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A comparison of emotion-focused therapy and cognitive-behavioural therapy in the treatment of generalised anxiety disorder
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Scientific title:
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A comparison of emotion-focused therapy and cognitive-behavioural therapy in the treatment of generalised anxiety disorder: a randomised controlled trial |
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Date of first enrolment:
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08/12/2017 |
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Target sample size:
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70 |
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Recruitment status: |
Completed |
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URL:
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https://www.isrctn.com/ISRCTN52689081 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Ireland
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Contacts
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Name:
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Ladislav
Timulak |
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Address:
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School of Psychology
Trinity College Dublin
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Dublin
Ireland |
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Key inclusion & exclusion criteria
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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
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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Generalised anxiety disorder (and some potential co-morbid symptoms/conditions)
Mental and Behavioural Disorders
Generalized anxiety disorder
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Intervention(s)
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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.
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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(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
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Secondary ID(s)
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HRA-POR-2015-1052
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Source(s) of Monetary Support
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Health Research Board
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Ethics review
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Status:
Approval date:
Contact:
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
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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20/10/2020 |
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URL:
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