Moving on After Breast Cancer Trial for Depressed Breast Cancer Survivors in Pakistan

NANot yet recruitingINTERVENTIONAL
Enrollment

26,376

Participants

Timeline

Start Date

June 13, 2025

Primary Completion Date

December 30, 2028

Study Completion Date

December 30, 2028

Conditions
Major Depressive Disorder (MDD)Breast Cancer Survivor
Interventions
OTHER

Non-specialist delivered Low intensity guided self-help (Khushi and Khatoon)

This is a manualised intervention comprising of 8 chapters. This is being further co-adapted to contexualise this for breast cancer survivours. The original manual is focused on stories of two breast cancer survivors , Mrs Khushi, means happiness) and Khatoon, means woman in Urdu, with depression and anxiety, describing how they help themselves using CBT strategies.

OTHER

Moving on After Breast Cancer (ABC) plus

This is a high intensity manualised intervention consisting of 12 sessions (60-90 minutes). This manual offers practical support and advice on life after breast cancer, managing difficulties, mindfulness, addressing fatigue, understanding the participant's model of illness, improving personal effectiveness and social relationships. The sessions also include therapist delivered psychoeducation using a CBT model of case formulation and goal setting: identification and formulation of predisposing, precipitating, perpetuating and protective factors of depression and/or anxiety, helping participants to identify core beliefs, where necessary, using downward arrow technique, identifying, and challenging unhealthy thinking patterns at the level of core beliefs using cognitive restructuring, and problem-solving techniques

DRUG

Standardised pharmacological treatment (antidepressants)

Patients will begin 12 weeks of sertraline treatment initiated at a daily dose of 50 mg for the first 4 weeks. After that, flexible titation of sertraline will be permitted, by 50mg increment every 1 to 2 weeks, as clinically indicated and tolerated to a maximum daily dose of 200 mg

OTHER

Enhanced Treatment As Usual (E-TAU)

Participants in this arm will continue to follow their routine visits to healthcare facilities. They will be regularly monitored by trained research team and will be assessed at weeks 6,18,30, and 48. In addition to psychological assessment at each follow-up, this will include information leaflets based on a brief psychoeducational module to educate participants and families about the risks, symptoms, management, and referral support information for anxiety and depression

Trial Locations (1)

75600

Pakistan Institute of Living and Learning, Karachi

All Listed Sponsors
collaborator

University of Sheffield

OTHER

collaborator

University of Manchester

OTHER

lead

Pakistan Institute of Living and Learning

OTHER