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 @ 3:22 AM
Ignite Modification Date:
2025-12-25 @ 3:22 AM
NCT ID:
NCT03750305
Eligibility Criteria:
Inclusion Criteria:
* Aged 18-68
* Sufficient Dutch language ability to permit the assessment to be completed.
* Diagnosis of DB (I or II or NOS) according to DSM-5 (clinicians assessment).
* Willing to complete daily and weekly monitoring throughout the duration of the study.
* Successful completion of the daily monitoring in the 4 weeks active run-in phase.
* Willing to be randomised to either imCT or psychoeducation/TAU condition
* Can commit to attending 12 consecutive weekly sessions imCT or psychoeducation/TAU.
Exclusion Criteria:
* Learning difficulties, organic brain disease or severe neurological impairment.
* Current severe substance or alcohol misuse (clinicians assessment).
* Current manic episode as diagnosed by DSM-5
* Current active psychotic symptoms
* Presence of active suicidal risk as indicated by a score of 2 or more on item 12 (i.e. frequent thought and/or plans to end their life) of the QIDS (Rush et al., 2003) confirmed by convergent clinical opinion.
* Taking part in concurrent treatment studies investigating pharmacological or psychological treatment for BD.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
68 Years
Study:
NCT03750305
Study Brief:
Protocol Section:
NCT03750305