Trials Sponsors Conditions Drugs Pricing

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

Longitudinal Interval Follow-up Evaluation
Longitudinal Interval Follow-up Evaluation (LIFE) is an integrated system for assessing the longitudinal course of psychiatric disorders. The assessment will consist of a semi-structured interview, during which an interviewer uses the LIFE to collect detailed psychosocial, psychopathologic, and treatment information for the follow-up interval. The weekly psychopathology measures are ordinal symptom-based scales with categories defined to match the criteria of the DSM-5.
Change in scores from baseline to months 3, 6, and 12

Secondary Outcomes (8)

Demographic Questionnaire
Baseline
Young Mania Rating Scale
Change in scores from baseline to months 3, 6, and 12
Hamilton Depression Rating Scale
Change in scores from baseline to months 3, 6, and 12
Quality of life scale
Change in scores from baseline to months 3, 6, and 12
Bipolar Recovery Questionnaire
Change in scores from baseline to months 3, 6, and 12
+3 more secondary outcomes

Study Arms (2)

CaPE Intervention

EXPERIMENTAL

CaPE is a manualized intervention consisting of 12 one-to-one psychoeducation sessions, one session per week. Each session will last for 60 minutes. All sessions will be delivered by a trained therapist who will receive two months training from senior therapists before starting intervention.

Behavioral: Culturally adapted Psychoeducation

Treatment as Usual

NO INTERVENTION

Treatment as usual (TAU) will be ascertained by the participant's treating physician. Research staff will record the nature and intensity of TAU delivered to each participant over a period of 3 months.

Interventions

Culturally adapted PsychoeducationBehavioral

This is a culturally adapted psychoeducation program consisting of 12 sessions. Each CaPE session lasts for approximately 60 minutes, beginning with a 20-30-minute presentation on the topic of the day, followed by a related exercise (e.g., drawing a life chart or compiling a list of potential triggers for recurrence).

CaPE Intervention

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Adult outpatients age 18 and above
Diagnosis of Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) bipolar disorder (both BD I and BD II), currently in remission, confirmed by Structured Clinical Interview for DSM-5 (SCID)

Sponsors & Collaborators

Pakistan Institute of Living and Learning
Otherlead
Centre for Addiction and Mental Health
Othercollaborator

Study Sites (1)

Lahore General Hospital

Lahore, Select An Option…, 55000, Pakistan

Related Publications (1)

Husain MI, Umer M, Asif M, Khoso AB, Kiran T, Ansari M, Aslam H, Bhatia MR, Dogar FA, Husain MO, Khan HA, Mufti AA, Mulsant BH, Naeem F, Naqvi HA, de Oliviera C, Siddiqui MS, Tamizuddin A, Wang W, Zaheer J, Husain N, Chaudhry N, Chaudhry IB. Culturally adapted psychoeducation for bipolar disorder in a low-resource setting: protocol for a multicentre randomised controlled trial. BJPsych Open. 2022 Nov 25;8(6):e206. doi: 10.1192/bjo.2022.598.
PMID: 36426568DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

Muhammad Ishrat Husain, MD
Centre for Addiction and Mental Health
PRINCIPAL INVESTIGATOR
Nasim Chaudhry, MD
Pakistan Institute of Living and Learning
PRINCIPAL INVESTIGATOR

Enrollment

303 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 25, 2022

First Posted

February 4, 2022

Study Start

June 20, 2022

Actual (reported)

Culturally Adapted Psychoeducation for Bipolar Disorder in a Low-resource Setting: A Randomized Controlled Trial

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (2)

CaPE Intervention

Treatment as Usual

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (2)

CaPE Intervention

Treatment as Usual

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations