Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2025-12-24 @ 2:24 PM
NCT ID:
NCT02449759
Eligibility Criteria:
Inclusion Criteria:
* On the primary care waiting list for individual therapy
* Anxiety or depression/low mood assessed using the Depression, Anxiety and Stress Scales (DASS21). Those with mild to moderate (≥ 4 and ≤ 7) mixed anxiety (including panic, agoraphobia, obsessive compulsive disorder, generalised anxiety disorder and phobias) or depressive/low mood (including dysthymia; ≥ 5 and ≤ 10) will be included.
* For those participants presenting with both anxiety and depression, at least one must reach the minimum cut off score and neither should exceed the maximum cut-off score.
* Adequate English ability
* Able to give informed consent
Exclusion Criteria:
* High suicide risk (as indicated with a risk score of \>0.3 on the Clinical Outcomes in Routine Evaluation questionnaire; CORE-34
* Participants that have been flagged at the referral meeting to receive specialised individual therapy (e.g. schema-focussed therapy)
* Medication change within the last three months\*
* Currently receiving or received psychological help within the last 6 months using a Cognitive Behavioural Therapy or ACT modality (e.g. Beating the Blues, Anxiety Management Groups, Mindfulness, Individual therapy)
* Currently taking part in another research study
* Intellectual impairment (e.g. a learning disability)
* Referral for a primary diagnosis, other than anxiety/depression, that would significantly over arch any work focusing on anxiety/depression even if the above criteria is met for anxiety/depression (e.g. an eating disorder whereby the stated symptoms: cognitions, physical sensations, emotions and behaviours, are orientated solely around food).
* Those individuals who have started or changed medication within the last 3 months will still be eligible to participate, but will be put on hold until this time period has elapsed. They will be informed of this and told that they may not be entered into the trial if recruitment targets are met or individual treatment becomes available (the waiting list will be reviewed at the time).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02449759
Study Brief:
Protocol Section:
NCT02449759