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:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-25 @ 4:49 AM
NCT ID:
NCT01981018
Eligibility Criteria:
Inclusion Criteria:
* Male or Female, aged 18 - 65 years old
* Have adequate English language ability to permit the assessment and experimental measures to be completed
* Have diagnosis of Bipolar Disorder (I or II or NOS) according to Diagnostic and Statistical Manual IV-TR (DSM-IV) criteria (American Psychiatric Association, 2000) as indicated by the Structured Clinical Interview for DSM-IV (SCID) (First, Spitzer, M., \& Williams, 2002)
* Are willing to complete daily/weekly mood and anxiety monitoring throughout the duration of the study
* Successfully complete daily monitoring in the 4 weeks active run-in phase
* Are willing to have regular treatment reports and letters sent to their GP and other relevant clinicians
* Can commit to attending 10 consecutive weekly sessions, including questionnaires completion, and follow up period as required by the study
* Are residents within geographical areas covered by the NHS trusts where treatment is delivered
Exclusion Criteria:
* Do not have diagnosis of Bipolar Disorder (I or II or NOS) according to Diagnostic and Statistical Manual IV-TR (DSM-IV) (American Psychiatric Association, 2000) criteria as indicated by the Structured Clinical Interview for DSM-IV (First et al., 2002)
* Learning difficulties, organic brain disease, severe neurological impairment
* Current severe substance or alcohol misuse (clinicians assessment)
* Current manic episode as diagnosed by DSM-IV criteria (American Psychiatric Association, 2000) indicated by the SCID (First et al., 2002)
* Current active psychotic symptoms
* Presence of active suicidal risk as indicated by a score of 2 or more on item 12 of the QIDS (Rush et al., 2003) (i.e. frequent thoughts and/or plans to end their life) confirmed by convergent clinical opinion
* Unwilling to engage actively in treatment or to use an imagery-focussed approach for treatment
* Taking part in concurrent treatment studies investigating pharmacological or psychological treatment for BD
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01981018
Study Brief:
Protocol Section:
NCT01981018