PsychosisTechCareNCT05567575
Cognitive Behavior Therapy (CBT) Informed Mobile-Application for First Episode Psychosis
A study testing Cognitive Behavioral Therapy, in people with Psychosis, run by Pakistan Institute of Living and Learning at 2 sites in Pakistan.
Trial summary
Onset of First Episode Psychosis (FEP) is at a young age and is a critical period influencing the long-term course of the disorder. Failure to identify FEP can lead to serious implications such as disruption of education, reduced long-term employment, huge economic burden, and is associated with significantly higher… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychosis
- What is being tested?
- Cognitive Behavioral Therapy,
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Oct 2022to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The inclusion criteria for the study will be:
- Male and Females patients diagnosed with FEP- Schizophrenia or Schizoaffective disorder.
- Over the age of 18 years.
- A score of three or more on any of the positive symptoms on the PANSS
- A Minimum score of one on the Calgary Depression scale (CDS)
- Having smart phone and able to use smart phone functions.
- Able to understand written and spoken Urdu.
Who cannot join
- Exclusions will be any evidence of organic brain disease, clinically significant concurrent medical illness, learning disability.
- unable to use simple functions of an android phone
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites, 2 recruiting
- Recruiting
Civil Hospital
Karachi, Sindh, 75500
Haider Naqvi, FCPS, (021) 99215740
- Recruiting
Institute of Psychiatry
Rawalpindi, Punjab Province
Asad Tamizuddin, MD
About this study
Official title: Culturally Adapted Cognitive Behavior Therapy (CBT) Informed Mobile-Application for First Episode Psychosis (FEP). A Feasibility Randomised Controlled Trial
Onset of First Episode Psychosis (FEP) is at a young age and is a critical period influencing the long-term course of the disorder. Failure to identify FEP can lead to serious implications such as disruption of education, reduced long-term employment, huge economic burden, and is associated with significantly higher mortality. The prevalence of psychosis increases rapidly from age 14 onwards with a peak incidence in the late teens and early 20s. The aim of the project is to examine the acceptability and feasibility of a mobile phone application-based intervention 'TechCare-PK', for individuals with psychosis in Pakistan. The main objectives are to determine whether appropriate individuals could be identified and recruited to the study and whether the TechCare App would be an acceptable intervention for individuals with psychosis.
Read the detailed description
Onset of First Episode Psychosis (FEP) is at a young age and is a critical period influencing the long-term course of the disorder. Failure to identify FEP can lead to serious implications such as disruption of education, reduced long-term employment, huge economic burden, and is associated with significantly higher mortality. The prevalence of psychosis increases rapidly from age 14 onwards with a peak incidence in the late teens and early 20s. The aim of the project is to examine the acceptability and feasibility of a mobile phone application-based intervention 'TechCare-PK', for individuals with psychosis in Pakistan. The main objectives are to determine whether appropriate individuals could be identified and recruited to the study and whether the TechCare App would be an acceptable intervention for individuals with psychosis.
Where there are challenges related to distance, inconvenience, being homebound or reluctance to face-to-face interventions, Mobile Health (mHealth) approaches that leverage mobile devices such as cellular phones and smartphones can be used to support healthcare system. Research has found mobile based interventions as highly acceptable to families and may meet carers' needs in respect of information, guidance, professional and emotional support. These services has been considered as a good and easy mode of exchanging information, providing health related education and advice, management of symptoms, to early recognize the complications, giving reassurance and for providing quality services.
Methods:
Study Design: A multi-center single blind Randomised Controlled Trial (RCT) comparing with Treatment as Usual (TAU) with participants with First Episode Psychosis (FEP) to be recruited from different psychiatric units across four cities in Pakistan i.e., Karachi, Lahore, Hyderabad and Rawalpindi, Pakistan. If required additional centers will be added i.e., Quetta, Multan and Peshawar following proper ethics amendments.
Aim The aim of this study is to design, and test culturally adapted mobile based CBT intervention for patients with FEP.
Objectives:
- Develop and refine an app based intervention (TechCare) based on existing culturally adapted intervention for psychosis, using patient and public involvement. The aim is to improve its potential efficacy, establish acceptability of the refined intervention to potential participants and facilitators and establish mobile app based deliverability of the intervention
- To explore the usefulness of TechCare as an acceptable intervention in reducing symptoms of psychosis.
- Undertake an internal pilot to establish recruitment and attrition rates, compliance with protocol and acceptability of the trial design to participants.
The proposed study will consist of three phases. First phase of study will focus on developing the app based intervention (TechCare) through qualitative work. Second phase will test run the application with 6-8 service users and incorporate suggestions and refinement of intervention and in the third phase we will test it in a randomised controlled trial.
- Conditions
- Psychosis
- Being tested
- Cognitive Behavioral Therapy,
- Keywords
- Psychosis, mHealth, Techonology, LMICs
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy,Behavioural
Also called Mobile Health
TechCare is based on the intelligent real time therapy (iRTT) conceptual model proposed by Kelly et al. iRTT relates to the use of mobile technologies to deliver interventions such as CBT, extending beyond assessment of symptoms. The intervention is based on the treatment manual developed by David G. Kingdon and Douglas Turkington. The intervention is informed by evidence based cognitive models of psychosis, where the participant is able to choose from a list of pre-selected digital self-help strategies that are personalised to each participant. For example, the App may incorporate the participant's favourite music in the form of multimedia or YouTube links, which are prompted during symptom elevation. Other examples may include psychoeducation, goal setting, problem-solving, etc., based on common self-help strategies in CBT for Psychosis (CBTp).
| Study group | Role | What they receive |
|---|---|---|
| TechCare | Experimental | Participants in this arm will receive a mobile app based cognitive behavior therapy informed "TechCare" intervention for a period of 12 weeks. Receives: Behavioral: Cognitive Behavioral Therapy, |
| Wait-List control group: | Active comparator | Participants in this arm will be offered the intervention once the intervention arm have completed their 3rd month outcome assessment. Receives: Behavioral: Cognitive Behavioral Therapy, |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility measures
Feasibility will be determined by recruitment rates, adherence rate and retention rates. The criterion for success of feasibility is to recruit >50% of eligible participants, adherence rate (number of home assignments completed; > 50%) and retention rate of 70%
Measured: From baseline to 3rd month (at the end of intervention)
Acceptability measure
Acceptability will be determined using participant feedback on the use of app
Measured: From baseline to 3rd month (at the end of intervention)
Secondary outcomes (6)
Positive and Negative Syndrome Scale
The Scale will indicate the Positive and Negative Syndrome for Schizophrenia that has been comprised of 30 items. The 30 items of semi structured questionnaire will measure positive syndromes, like delusions, hallucinations and conceptual disorganization whereas negative syndromes include passive or apathetic social avoidance and blunted affect.
Measured: Changes from baseline to week-12
Psychotic Symptom Rating Scales (PSYRATS)
The dimensions of hallucinations and delusions will be measured by a semi structured interview scale . The dimensions of hallucinations and delusions will be measured by a semi structured interview scale
Measured: Changes from baseline to week-12
Calgary Depression Scale (CDS)
The scale is specially designed to measure the depression for Psychosis, consist of nine items (Addington et al., 1990). CDS will indicate the subjective and qualitative dimensions of depression in Schizophrenia.
Measured: Changes from baseline to week-12
The Work and Social Adjustment Scale (WSAS)
Five items scale that measures the perceived impairment of social life, relationships, home management, work and private leisure having scores between 0 to 8 that means 0 (no impairment) and 8 (very severe impairment) with a total score of 40 (Mundt, Marks, Shear, \& Greist, 2002).
Measured: Changes from baseline to week-12
EuroQol-5 Dimensions EQ5-D
An instrument measures the health-related quality of life. Quality of life will be measured in five dimensions, including usual activities, anxiety/depression, pain/discomfort, self-care and mobility (Sobocki et al 2007).
Measured: Changes from baseline to week-12
Client Service Receipt Inventory (CSRI):
We will collect information about the use of other health services (including the informal sector faith healers/Imams) using CSRI.
Measured: Changes from baseline to week-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start1 Oct 2022
- Primary completion30 Dec 2024 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Living and Learning
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Omair Husain, MD, Principal investigator, Centre for Addiciton and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567575
- Sponsor's protocol ID
- TechCare-001
- Acronym
- TechCare
- Status last verified
- May 2024
- First submitted
- 1 Oct 2022
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Adapted Cognitive Behavior Therapy (CBT) Informed Mobile-Application for First Episode Psychosis (FEP). A Feasibility Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05567575
- Acronym / sponsor ID
- TechCare / TechCare-001
- Conditions
- Psychosis
- Keywords
- Psychosis, mHealth, Techonology, LMICs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 5 Oct 2022 (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.
Onset of First Episode Psychosis (FEP) is at a young age and is a critical period influencing the long-term course of the disorder. Failure to identify FEP can lead to serious implications such as disruption of education, reduced long-term employment, huge economic burden, and is associated with significantly higher mortality. The prevalence of psychosis increases rapidly from age 14 onwards with a peak incidence in the late teens and early 20s. The aim of the project is to examine the acceptability and feasibility of a mobile phone application-based intervention 'TechCare-PK', for individuals with psychosis in Pakistan. The main objectives are to determine whether appropriate individuals could be identified and recruited to the study and whether the TechCare App would be an acceptable intervention for individuals with psychosis.
Detailed description
Onset of First Episode Psychosis (FEP) is at a young age and is a critical period influencing the long-term course of the disorder. Failure to identify FEP can lead to serious implications such as disruption of education, reduced long-term employment, huge economic burden, and is associated with significantly higher mortality. The prevalence of psychosis increases rapidly from age 14 onwards with a peak incidence in the late teens and early 20s. The aim of the project is to examine the acceptability and feasibility of a mobile phone application-based intervention 'TechCare-PK', for individuals with psychosis in Pakistan. The main objectives are to determine whether appropriate individuals could be identified and recruited to the study and whether the TechCare App would be an acceptable intervention for individuals with psychosis.
Where there are challenges related to distance, inconvenience, being homebound or reluctance to face-to-face interventions, Mobile Health (mHealth) approaches that leverage mobile devices such as cellular phones and smartphones can be used to support healthcare system. Research has found mobile based interventions as highly acceptable to families and may meet carers' needs in respect of information, guidance, professional and emotional support. These services has been considered as a good and easy mode of exchanging information, providing health related education and advice, management of symptoms, to early recognize the complications, giving reassurance and for providing quality services.
Methods:
Study Design: A multi-center single blind Randomised Controlled Trial (RCT) comparing with Treatment as Usual (TAU) with participants with First Episode Psychosis (FEP) to be recruited from different psychiatric units across four cities in Pakistan i.e., Karachi, Lahore, Hyderabad and Rawalpindi, Pakistan. If required additional centers will be added i.e., Quetta, Multan and Peshawar following proper ethics amendments.
Aim The aim of this study is to design, and test culturally adapted mobile based CBT intervention for patients with FEP.
Objectives:
- Develop and refine an app based intervention (TechCare) based on existing culturally adapted intervention for psychosis, using patient and public involvement. The aim is to improve its potential efficacy, establish acceptability of the refined intervention to potential participants and facilitators and establish mobile app based deliverability of the intervention
- To explore the usefulness of TechCare as an acceptable intervention in reducing symptoms of psychosis.
- Undertake an internal pilot to establish recruitment and attrition rates, compliance with protocol and acceptability of the trial design to participants.
The proposed study will consist of three phases. First phase of study will focus on developing the app based intervention (TechCare) through qualitative work. Second phase will test run the application with 6-8 service users and incorporate suggestions and refinement of intervention and in the third phase we will test it in a randomised controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TechCare | Experimental | Behavioral: Cognitive Behavioral Therapy,Participants in this arm will receive a mobile app based cognitive behavior therapy informed "TechCare" intervention for a period of 12 weeks. |
| Wait-List control group: | Active comparator | Behavioral: Cognitive Behavioral Therapy,Participants in this arm will be offered the intervention once the intervention arm have completed their 3rd month outcome assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The inclusion criteria for the study will be:
- Male and Females patients diagnosed with FEP- Schizophrenia or Schizoaffective disorder.
- Over the age of 18 years.
- A score of three or more on any of the positive symptoms on the PANSS
- A Minimum score of one on the Calgary Depression scale (CDS)
Key exclusion criteria (2 listed)
- Exclusions will be any evidence of organic brain disease, clinically significant concurrent medical illness, learning disability.
- unable to use simple functions of an android phone
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 |
|---|---|---|
| Cognitive Behavioral Therapy,Also: Mobile HealthTechCare is based on the intelligent real time therapy (iRTT) conceptual model proposed by Kelly et al. iRTT relates to the use of mobile technologies to deliver interventions such as CBT, extending beyond assessment of symptoms. The intervention is based on the treatment manual developed by David G. Kingdon and Douglas Turkington. The intervention is informed by evidence based cognitive models of psychosis, where the participant is able to choose from a list of pre-selected digital self-help strategies that are personalised to each participant. For example, the App may incorporate the participant's favourite music in the form of multimedia or YouTube links, which are prompted during symptom elevation. Other examples may include psychoeducation, goal setting, problem-solving, etc., based on common self-help strategies in CBT for Psychosis (CBTp). | Behavioural | TechCare, Wait-List control group: |
Primary outcome
Feasibility measures
Time frame: From baseline to 3rd month (at the end of intervention)
Feasibility will be determined by recruitment rates, adherence rate and retention rates. The criterion for success of feasibility is to recruit >50% of eligible participants, adherence rate (number of home assignments completed; > 50%) and retention rate of 70%
Acceptability measure
Time frame: From baseline to 3rd month (at the end of intervention)
Acceptability will be determined using participant feedback on the use of app
6 secondary outcomes
Positive and Negative Syndrome Scale
Time frame: Changes from baseline to week-12
Psychotic Symptom Rating Scales (PSYRATS)
Time frame: Changes from baseline to week-12
Calgary Depression Scale (CDS)
Time frame: Changes from baseline to week-12
The Work and Social Adjustment Scale (WSAS)
Time frame: Changes from baseline to week-12
EuroQol-5 Dimensions EQ5-D
Time frame: Changes from baseline to week-12
Client Service Receipt Inventory (CSRI):
Time frame: Changes from baseline to week-12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Omair Husain, MD principal investigator
Centre for Addiciton and Mental Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy, in people with Psychosis, run by Pakistan Institute of Living and Learning at 2 sites 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 7 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ameer B Khoso, Mphil (02135871845, ameer.bukhsh@pill.org.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility measures (time frame: From baseline to 3rd month (at the end of intervention)). The study lists 2 primary outcomes in all. 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 17 May 2024.