A trial of a new psychological intervention of cognitive behaviour therapy for young people with distressing mood swings

Not Applicable

• Conditions: Bipolar disorder; Mental and Behavioural Disorders; Bipolar affective disorder

• Registration Number: ISRCTN13363197
• Lead Sponsor: Greater Manchester Mental Health NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-25
• Last Update Posted: 9 September 2024
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 338

Inclusion Criteria

The study population are young people meeting BAR criteria. The inclusion criteria are:
1. 16-25 years old
2. Meet criteria for one of the following groups in the last 12 months (as assessed by the SCID-5):
2.1. Group I: Sub-threshold mania.
For at least 2 consecutive days but less than 7 days: period of abnormally and persistently elevated, expansive or irritable mood + at least 2 criteria from the list (>=3 for irritable mood):
2.1.1. Inflated self­-esteem/grandiosity
2.1.2. Decreased need for sleep
2.1.3. More talkative than usual
2.1.4. Flight of ideas/racing thoughts
2.1.5. Distractibility
2.1.6. Increase goal-directed activity or psychomotor agitation
2.1.7. Excessive involvement in activities that have a high potential for painful consequences
2.2. Group II: Depression + Cyclothymic features:
Depression (for at least 1 week): depressed mood/loss of interest or please + two criteria from the list:
2.2.1. Significant weight loss
2.2.2. Insomnia or hypermania nearly every day
2.2.3. Psychomotor retardation/agitation
2.2.4. Fatigue/loss of energy
2.2.5. Feelings of worthlessness/excessive or inappropriate guilt
2.2.6. Diminished ability to think or concentrate
2.2.7. Recurrent thoughts of death/suicidal ideation
PLUS
Cyclothymic features: numerous episodes with sub-threshold manic symptoms not meeting Group 1 criteria: subthreshold mania as defined in Group 1 for 4 hours within a 24-hour period and at least 4 cumulative lifetime days in the past 12 months.
2.3. Group III: Depression + genetic risk:
Depression (See Group 2)
PLUS
Genetic risk: first degree relative with BD
3. Help seeking
4. Provision of written informed consent

Exclusion Criteria

1. History of a treated/untreated manic episode or psychosis of 1-week duration or longer
2. Treatment with a mood stabiliser for longer than 6 weeks or antipsychotic for 3 weeks (that evidences exclusion on point a or at the time of the assessment whereby at-risk status cannot be confirmed)
3. Organic brain disorder
4. Unable to complete assessments due to language barriers
5. Inpatient/acute psychiatric care needed
6. Primary substance abuse/dependency

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mood swing symptom severity averaged over the prior 4 weeks, measured by the SCID-5 + Psychiatric Status Ratings/PSRs (SCID Longitudinal Follow-Up Evaluation (LIFE) at the 27-week timepoint