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Cognitive Behavior Therapy (CBT) Informed Mobile-Application for First Episode Psychosis (TechCare)

P

Pakistan Institute of Living and Learning

Status

Enrolling

Conditions

Psychosis

Treatments

Behavioral: Cognitive Behavioral Therapy,

Study type

Interventional

Funder types

Other

Identifiers

NCT05567575
TechCare-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups

TechCare
Experimental group
Description:
Participants in this arm will receive a mobile app based cognitive behavior therapy informed "TechCare" intervention for a period of 12 weeks.
Treatment:
Behavioral: Cognitive Behavioral Therapy,
Wait-List control group:
Active Comparator group
Description:
Participants in this arm will be offered the intervention once the intervention arm have completed their 3rd month outcome assessment.
Treatment:
Behavioral: Cognitive Behavioral Therapy,

Trial contacts and locations

2

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Central trial contact

Ameer B Khoso, Mphil; Zaib un Nisa, Mphil

Data sourced from clinicaltrials.gov

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