Study objectives:

        1. To determine the effectiveness of the CaPE intervention compared to treatment as usual
           (TAU) in reducing the time to recurrence for people with bipolar disorder (BD) I/II,
           currently in remission in Pakistan

        2. To determine the impact of the CaPE intervention compared to TAU on clinical outcomes,
           quality of life and functioning; and

        3. To estimate the cost-effectiveness of CaPE in a low-resource setting (i.e., Pakistan)
           (if the RCT confirms the effectiveness of CaPE in BD.

      Study design and setting:

      This will be a multi-centre, assessor blind, individual, parallel-arm randomized controlled
      trial (RCT) with Pakistani patients with BD.

      Sample Size:

      The study aims to recruit a total of N=300 participants in total.

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

Bipolar Disorder

Psychoeducation (PE) is an effective adjunctive treatment option in BD, however, despite the
      clear benefits, there are only limited, underpowered studies of PE from LMICs, including
      Pakistan. Therefore, the current study aims to test the effectiveness of Culturally adapted
      PsychoEducation (CaPE) intervention for people with BD in Pakistan. The study will include a
      total of N=300 people with BD from psychiatric units of teaching and non-teaching hospitals
      in 8 centres across Pakistan including Karachi, Lahore, Multan, Rawalpindi, Peshawar,
      Hyderabad, Shaheed Benazirabad and Quetta. Consented participants meeting eligibility
      criteria will be randomised in a 1:1 allocation to CaPE or TAU. Randomization will be
      computer generated and use a random permuted block method with variable block sizes
      stratified by site, bipolar type (I or II) and self-reported sex. Participants in CaPE
      intervention group will receive 12-weekly one-to-one psychoeducation sessions. Each CaPE
      session will last for approximately 1 hour, 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). Sessions will be delivered by trained
      psychologists who will receive regular weekly supervision to maintain fidelity. The other
      group will receive TAU/control group. Assessments will be carried out at baseline, months 3,
      6, and 12 either in-person and/or via secure videoconference software (alternatives to
      in-person for COVID-19 or travel restrictions) by trained, blinded research analysts (RAs).
      The treatment groups will be compared with each other at baseline and then at subsequent
      follow-ups at 3, 6 and 12 months. We will also conduct in-depth, one-to-one interviews with
      service users from the intervention arm (15-20), carers (15-20) and all therapists involved
      in the trial. A cost-utility analysis from a healthcare system and societal perspective will
      be conducted to establish the cost-effectiveness of CaPE against TAU.

Culturally adapted Psychoeducation

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.

Demographic Questionnaire will be used to assess baseline demographics including age, gender, self-reported sex, marital status, smoking status, employment status, education and monthly income.

Young Mania Rating Scale (YMRS) will be used to assess manic symptom severity. The scale has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours.

Hamilton Depression Rating Scale (HDRS-17) is a clinician-administered scale that will be used to measure severity of depression symptoms.

EuroQol-5D (EQ- 5D) EQ-5D will be used to assess health-related quality of life over 5 dimensions (mobility, self-care, daily activities, pain-discomfort, anxiety and depression) 44. It also includes and a Visual Analogue Scale that evaluates patients' perceived health status.

Bipolar Recovery Questionnaire (BRQ) is a 36-item questionnaire that will be used to measure functioning and personal experiences of recovery specific to patients with BD.

Morisky Medication Adherence Scale-4-item will be used to measure medication adherence.

Bipolar Knowledge and Attitudes Questionnaire (BKAQ) is a 25-item questionnaire developed for use in primary care to assess knowledge and attitudes towards bipolar disorder.

Client Service Receipt Inventory (CSRI) is a tool used to collect information on the whole range of services and supports study participants may be accessing.

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.

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.

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

About this trial

Study ID

Status

Type

Phase

Placebo

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Trial Timing

What is this trial about?

What are the participation requirements?

Locations

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