Major Depressive Disorder (MDD)Moving On ABCNCT07015944
Moving on After Breast Cancer Trial for Depressed Breast Cancer Survivors in Pakistan
A study testing Non-specialist delivered Low intensity guided self-help (Khushi and Khatoon), Moving on After Breast Cancer (ABC) plus and Standardised pharmacological treatment (antidepressants) in people with Major Depressive Disorder (MDD) and Breast Cancer Survivor, run by Pakistan Institute of Living and Learning at 1 site in Pakistan.
Trial summary
Breast cancer is the most common cancer among women worldwide, and many survivors experience comorbid mental health conditions such as depression and anxiety, which can significantly worsen health outcomes and increase mortality. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Major Depressive Disorder (MDD), Breast Cancer Survivor
- What is being tested?
- Non-specialist delivered Low intensity guided self-help (Khushi and Khatoon), Moving on After Breast Cancer (ABC) plus and Standardised pharmacological treatment (antidepressants)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26,376 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Jun 2025to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women
- Aged 18 years and above
- Diagnosed with breast cancer (any stage)
- Completed initial treatment (i.e., surgery and/or radiotherapy or chemotherapy) for breast cancer (even if they are currently on hormonal therapy post-initial treatment)
- Total score of 10 or above on the Patient Health Questionnaire (PHQ-9)
- Diagnosis of current Major Depressive Episode (MDE) confirmed using the Structured Clinical Interview for DSM-5 (SCID).
Who cannot join
- Lacking capacity to provide informed consent, such as those identified by clinicians as having intellectual disabilities, dementia, or severe medical and/or psychiatric illnesses requiring hospitalisation
- Unable to engage in assessments or interventions, including those with stage 4 breast cancer experiencing significant symptoms (e.g., metastatic lesions in the lungs, liver, or bones requiring daily treatment for symptomatic relief, such as the daily use of two or more painkillers), which restrict their capacity to participate
- Currently receiving psychological therapy or taking antidepressant medications (e.g., SSRIs, SNRIs, or other prescribed antidepressants)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Pakistan Institute of Living and Learning
Karachi, Sindh, 75600
Tayyeba Kiran, PhD, 0923328262142, tayyaba.kiran@pill.org.pk
Rabia Fahad, PhD Fellow, 0922135371084, rabia.sattar@pill.org.pk
About this study
Official title: Clinical and Cost-effectiveness of an Integrated Psychosocial Care Plan for Comorbid Depression in Breast Cancer Survivors In Pakistan: A Sequential Multiple Assignment Randomised Trial
Breast cancer is the most common cancer among women worldwide, and many survivors experience comorbid mental health conditions such as depression and anxiety, which can significantly worsen health outcomes and increase mortality. This large-scale trial in Pakistan aims to evaluate the clinical and cost-effectiveness of a three-stage adaptive intervention to manage depression among breast cancer survivors. Using a Sequential, Multiple Assignment, Randomised Trial (SMART) design, the study will recruit 26,372 participants aged 18 and above who have completed initial breast cancer treatment (surgery and/or chemotherapy or radiotherapy). Participants will be identified through primary care units, outpatient departments, oncology clinics in public hospitals, and charitable organisations across Pakistan. Depression will be screened using the Patient Health Questionnaire PHQ-9, with diagnosis confirmed by the Structured Clinical Interview Schedule of DSM (SCID). Those randomised to the intervention arm will receive adaptive interventions: starting with low-intensity guided self-help, followed by a high-intensity cognitive behavioural therapy-based programme called "Moving On After Breast Cancer Plus" (Moving on ABC Plus), and for non-responders, an additional pharmacological component will be introduced. Participants in both adaptive intervention and enhance usual care groups will be assessed at multiple time points-baseline, 6, 18, 30, and 48 weeks post-randomisation-using validated tools to measure depression (primary outcome), and anxiety, self-esteem, intrusive thoughts, health-related quality of life, satisfaction with services, and health resource use (secondary outcomes). The study will also include qualitative interviews and focus groups discussions with patients, caregivers, healthcare providers, and policymakers to identify barriers and facilitators to implementation and ensure the intervention is both contextually appropriate and scalable.
Read the detailed description
Problem statement: Breast cancer is the most prevalent cancer among women globally. The comorbidity of mental health conditions, such as depression and anxiety, significantly increases mortality rates in this population. Despite the complex rehabilitation needs of breast cancer survivors, there is limited knowledge on how to provide individualised support effectively.
Aims/Objectives: The overarching aim of this trial is to evaluate the clinical and cost-effectiveness of a three-stage adaptive intervention for co-morbid depression among breast cancer survivors in Pakistan.
Methods: This study will use a Sequential, Multiple Assignment, Randomised Trial (SMART) design to recruit 26,372 breast cancer survivors who have completed initial treatment (surgery and/or radiotherapy or chemotherapy). Participants, aged 18 years and older, will be recruited from primary care units, medical outpatient units, oncology clinics in public hospitals, and charitable organisations across Pakistan. Eligible participants will be screened for Major Depressive Episode (MDE) using the Patient Health Questionnaire (PHQ-9), with a score of 10 or above indicating potential depression. Diagnosis will be confirmed through the Structured Clinical Interview Schedule (SCID). Participants randomised to the intervention arm will receive a three-stage adaptive intervention, progressing through the following levels based on response: First adaptive intervention - Low-intensity guided self-help. Second adaptive intervention - High intensity "Moving On After Breast Cancer Plus" (Moving on ABC Plus), incorporating Cognitive Behavioural Therapy (CBT). Third adaptive intervention - Moving on ABC Plus combined with pharmacological intervention. All participants, regardless of randomisation, will be assessed at baseline, 6-, 18-, 30-, and 48-weeks post-randomisation using standardised questionnaires to measure: Primary outcome: Depression. Secondary outcomes: Anxiety, self-esteem, intrusive thoughts, health-related quality of life, satisfaction with services, and resource utilisation. Additionally, in-depth interviews and focus group discussions (FGDs) will be conducted with multiple stakeholders-including healthcare providers, policymakers, patients, and caregivers-to explore barriers and facilitators of intervention implementation.
- Being tested
- Non-specialist delivered Low intensity guided self-help (Khushi and Khatoon), Moving on After Breast Cancer (ABC) plus, Standardised pharmacological treatment (antidepressants), Enhanced Treatment As Usual (E-TAU)
- Keywords
- Breast Cancer, LMICs, Depression, Multimorbidity, SMART, Adaptive interventions, Cognitive Behaviour Therapy, Low intensity intervention
- Medical subject headings
- Depressive Disorder, Major, Breast Neoplasms, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-specialist delivered Low intensity guided self-help (Khushi and Khatoon)Other
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.
Moving on After Breast Cancer (ABC) plusOther
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
Standardised pharmacological treatment (antidepressants)Drug
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
Enhanced Treatment As Usual (E-TAU)Other
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
| Study group | Role | What they receive |
|---|---|---|
| Adaptive interventions | Experimental | The adaptive interventions include:
1. Non-specialist delivered Low intensity guided self-help (Khushi and Khatoon)
2. Moving on After Breast cancer Plus (Moving on ABC Plus)
3. Standard pharmacological intervention Receives: Other: Non-specialist delivered Low intensity guided self-help (Khushi and Khatoon); Other: Moving on After Breast Cancer (ABC) plus; Drug: Standardised pharmacological treatment (antidepressants); Other: Enhanced Treatment As Usual (E-TAU) |
| Enhanced Treatment As Usual (E-TAU) | Other | 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 about the risks, symptoms, management, and referral support information for anxiety and depression. Receives: Other: Enhanced Treatment As Usual (E-TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for Depression
Primary outcome will be depression remission at 48 weeks. This is a 17 item, clinician administered assessment measure to assess severity of depressive symptoms over past week. Total score of 0-7 is considered as "normal" (clinical remission), and a total score of 20 or higher is considered as moderate to severe.
Measured: Change in total score from baseline to week 48
Secondary outcomes (7)
Generalized Anxiety Disorder
Severity of anxiety over last two weeks will be assessed using the Generalized Anxiety Disorder - 7 . Individuals with total score between 0 to 4 will be categories as having "minimal anxiety", 5 to 9 "mild anxiety", 10 to 14 "moderate anxiety" and 15 to 21 "severe anxiety".
Measured: Change in Total Score from baseline to week 6, 18, 30 and 48
EuroQol-5 Dimensions
Health-related quality of life will be assessed using the EQ-5D. This questionnaire assesses quality of life by exploring 5 areas: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is rated as one of the followings: no problems, slight problems, moderate problems, severe problems and extreme problems. Higher score indicate better quality of life. The range for EQ-5D scores is between -0.594 and 1, where 1 signifies full health. Scores below 0 indicate health states worse than death.
Measured: Change in total score from baseline to week 6, 18, 30 ans 48
Functional Assessment of Cancer Therapy - Breast
This scale measures health-related quality of life in breast cancer patients in five domains: physical, social, emotional, functional well-being as well as a breast-cancer sub-scale Higher score indicate better quality of life. Minimum possible score on this scale is 0 and maximum possible score is 144.
Measured: Change in total score from baseline to week 6, 18, 30 and 48
Rosenberg Self Esteem Scale
Self-esteem will be assessed using this scale. Total score on the scale ranges from 0-30. Total score between 15 to 25 is considered as within normal range and total score below 15 is indicative of low self-esteem
Measured: Change in total score from baseline to week 6, 18, 30 and 48
Multidimensional Scale for Perceived Social Support
This scale aims to assess an individual's perception of support from 3 sources: family, friends and a significant other. Total score between 12 to 35 is categorised as "low perceived support", 36 to 60 "medium perceived support", and 61 to 84 "high perceived support".
Measured: Change in total score from baseline to week 6, 18, 30 and 48
Client Satisfaction Questionnaire
Satisfaction with treatment/services will be assessed using this scale. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Measured: Change in total score from baseline to week 6, 18, 30 and 48.
Client Service Receipt Inventory
Information on participants' use of both formal and informal (such as Imams/faith healers) health services was collected at baseline and follow-up assessments using a structured form.
Measured: Change in score from baseline to week 6, 18, 30 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start13 Jun 2025
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sequential, Multiple Assignment, Randomized Trial (SMART). The SMART design allows investigators to evaluate the effects of different intervention options and develop an adaptive approach to better meet participants' needs
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26,376 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Living and Learning
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sheffield, University of Manchester
- Responsible party
- Sponsor
- Investigators
- Nasim Chaudhry, MD, Principal investigator, Pakistan Institute of Living and Learning
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015944
- Sponsor's protocol ID
- Moving On ABC Plus
- Other IDs
- NIHR205561
- Acronym
- Moving On ABC
- Status last verified
- Mar 2026
- First submitted
- 3 Jun 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only anonymized data will be shared. Requests to be made to Principal Investigator
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Cost-effectiveness of an Integrated Psychosocial Care Plan for Comorbid Depression in Breast Cancer Survivors In Pakistan: A Sequential Multiple Assignment Randomised Trial
- ClinicalTrials.gov ID
- NCT07015944
- Acronym / sponsor ID
- Moving On ABC / Moving On ABC Plus
- Keywords
- Breast Cancer, LMICs, Depression, Multimorbidity, SMART, Adaptive interventions, Cognitive Behaviour Therapy, Low intensity intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26,376 participants (estimated)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Collaborators
- University of Sheffield, University of Manchester
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breast cancer is the most common cancer among women worldwide, and many survivors experience comorbid mental health conditions such as depression and anxiety, which can significantly worsen health outcomes and increase mortality. This large-scale trial in Pakistan aims to evaluate the clinical and cost-effectiveness of a three-stage adaptive intervention to manage depression among breast cancer survivors. Using a Sequential, Multiple Assignment, Randomised Trial (SMART) design, the study will recruit 26,372 participants aged 18 and above who have completed initial breast cancer treatment (surgery and/or chemotherapy or radiotherapy). Participants will be identified through primary care units, outpatient departments, oncology clinics in public hospitals, and charitable organisations across Pakistan. Depression will be screened using the Patient Health Questionnaire PHQ-9, with diagnosis confirmed by the Structured Clinical Interview Schedule of DSM (SCID). Those randomised to the intervention arm will receive adaptive interventions: starting with low-intensity guided self-help, followed by a high-intensity cognitive behavioural therapy-based programme called "Moving On After Breast Cancer Plus" (Moving on ABC Plus), and for non-responders, an additional pharmacological component will be introduced. Participants in both adaptive intervention and enhance usual care groups will be assessed at multiple time points-baseline, 6, 18, 30, and 48 weeks post-randomisation-using validated tools to measure depression (primary outcome), and anxiety, self-esteem, intrusive thoughts, health-related quality of life, satisfaction with services, and health resource use (secondary outcomes). The study will also include qualitative interviews and focus groups discussions with patients, caregivers, healthcare providers, and policymakers to identify barriers and facilitators to implementation and ensure the intervention is both contextually appropriate and scalable.
Detailed description
Problem statement: Breast cancer is the most prevalent cancer among women globally. The comorbidity of mental health conditions, such as depression and anxiety, significantly increases mortality rates in this population. Despite the complex rehabilitation needs of breast cancer survivors, there is limited knowledge on how to provide individualised support effectively.
Aims/Objectives: The overarching aim of this trial is to evaluate the clinical and cost-effectiveness of a three-stage adaptive intervention for co-morbid depression among breast cancer survivors in Pakistan.
Methods: This study will use a Sequential, Multiple Assignment, Randomised Trial (SMART) design to recruit 26,372 breast cancer survivors who have completed initial treatment (surgery and/or radiotherapy or chemotherapy). Participants, aged 18 years and older, will be recruited from primary care units, medical outpatient units, oncology clinics in public hospitals, and charitable organisations across Pakistan. Eligible participants will be screened for Major Depressive Episode (MDE) using the Patient Health Questionnaire (PHQ-9), with a score of 10 or above indicating potential depression. Diagnosis will be confirmed through the Structured Clinical Interview Schedule (SCID). Participants randomised to the intervention arm will receive a three-stage adaptive intervention, progressing through the following levels based on response: First adaptive intervention - Low-intensity guided self-help. Second adaptive intervention - High intensity "Moving On After Breast Cancer Plus" (Moving on ABC Plus), incorporating Cognitive Behavioural Therapy (CBT). Third adaptive intervention - Moving on ABC Plus combined with pharmacological intervention. All participants, regardless of randomisation, will be assessed at baseline, 6-, 18-, 30-, and 48-weeks post-randomisation using standardised questionnaires to measure: Primary outcome: Depression. Secondary outcomes: Anxiety, self-esteem, intrusive thoughts, health-related quality of life, satisfaction with services, and resource utilisation. Additionally, in-depth interviews and focus group discussions (FGDs) will be conducted with multiple stakeholders-including healthcare providers, policymakers, patients, and caregivers-to explore barriers and facilitators of intervention implementation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Sequential, Multiple Assignment, Randomized Trial (SMART). The SMART design allows investigators to evaluate the effects of different intervention options and develop an adaptive approach to better meet participants' needs
| Arm | Type | Receives |
|---|---|---|
| Adaptive interventions | Experimental | Other: Non-specialist delivered Low intensity guided self-help (Khushi and Khatoon), Other: Moving on After Breast Cancer (ABC) plus, Drug: Standardised pharmacological treatment (antidepressants), Other: Enhanced Treatment As Usual (E-TAU)The adaptive interventions include: 1. Non-specialist delivered Low intensity guided self-help (Khushi and Khatoon) 2. Moving on After Breast cancer Plus (Moving on ABC Plus) 3. Standard pharmacological intervention |
| Enhanced Treatment As Usual (E-TAU) | Other | 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 about the risks, symptoms, management, and referral support information for anxiety and depression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women
- Aged 18 years and above
- Diagnosed with breast cancer (any stage)
- Completed initial treatment (i.e., surgery and/or radiotherapy or chemotherapy) for breast cancer (even if they are currently on hormonal therapy post-initial treatment)
- Total score of 10 or above on the Patient Health Questionnaire (PHQ-9)
Key exclusion criteria (3 listed)
- Lacking capacity to provide informed consent, such as those identified by clinicians as having intellectual disabilities, dementia, or severe medical and/or psychiatric illnesses requiring hospitalisation
- Unable to engage in assessments or interventions, including those with stage 4 breast cancer experiencing significant symptoms (e.g., metastatic lesions in the lungs, liver, or bones requiring daily treatment for symptomatic relief, such as the daily use of two or more painkillers), which restrict their capacity to participate
- Currently receiving psychological therapy or taking antidepressant medications (e.g., SSRIs, SNRIs, or other prescribed antidepressants)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Adaptive interventions |
| Moving on After Breast Cancer (ABC) plusThis 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 | Other | Adaptive interventions |
| 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 | Drug | Adaptive interventions |
| 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 | Other | Adaptive interventions, Enhanced Treatment As Usual (E-TAU) |
Primary outcome
Hamilton Rating Scale for Depression
Time frame: Change in total score from baseline to week 48
Primary outcome will be depression remission at 48 weeks. This is a 17 item, clinician administered assessment measure to assess severity of depressive symptoms over past week. Total score of 0-7 is considered as "normal" (clinical remission), and a total score of 20 or higher is considered as moderate to severe.
7 secondary outcomes
Generalized Anxiety Disorder
Time frame: Change in Total Score from baseline to week 6, 18, 30 and 48
EuroQol-5 Dimensions
Time frame: Change in total score from baseline to week 6, 18, 30 ans 48
Functional Assessment of Cancer Therapy - Breast
Time frame: Change in total score from baseline to week 6, 18, 30 and 48
Rosenberg Self Esteem Scale
Time frame: Change in total score from baseline to week 6, 18, 30 and 48
Multidimensional Scale for Perceived Social Support
Time frame: Change in total score from baseline to week 6, 18, 30 and 48
Client Satisfaction Questionnaire
Time frame: Change in total score from baseline to week 6, 18, 30 and 48.
Client Service Receipt Inventory
Time frame: Change in score from baseline to week 6, 18, 30 and 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: Yes. Only anonymized data will be shared. Requests to be made to Principal Investigator
Related trials for Major Depressive Disorder (MDD)
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
Active, not recruiting
Feasibility of Home-Based Intermittent 60Hz Light Therapy for Major Depressive Disorder (MDD)
Depression, MDD
RecruitingPhase 2
ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response
Major Depressive Disorder (MDD), Depressive Disorder, Treatment-Resistant
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
RecruitingPhase 3
Efficacy of Statins Among Major Depressive Disorder
Major Depressive Disorder, MDD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nasim Chaudhry, MD principal investigator
Pakistan Institute of Living and Learning
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-specialist delivered Low intensity guided self-help (Khushi and Khatoon), Moving on After Breast Cancer (ABC) plus and Standardised pharmacological treatment (antidepressants) in people with Major Depressive Disorder (MDD) and Breast Cancer Survivor, run by Pakistan Institute of Living and Learning at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tayyeba Kiran, PhD (0923328262142, tayyaba.kiran@pill.org.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Rating Scale for Depression (time frame: Change in total score from baseline to week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.