Clinical trial NCT05567575: Cognitive Behavior Therapy (CBT) Informed Mobile-Application for First Episode Psychosis
Official title: Culturally Adapted Cognitive Behavior Therapy (CBT) Informed Mobile-Application for First Episode Psychosis (FEP). A Feasibility Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychosis
Keywords: Psychosis
mHealth
Techonology
LMICs
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
First posted: 2022-10-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility measures
timeFrame: From baseline to 3rd month (at the end of intervention)
measure: Acceptability measure
timeFrame: From baseline to 3rd month (at the end of intervention)
Secondary outcomes:
measure: Positive and Negative Syndrome Scale
timeFrame: Changes from baseline to week-12
measure: Psychotic Symptom Rating Scales (PSYRATS)
timeFrame: Changes from baseline to week-12
measure: Calgary Depression Scale (CDS)
timeFrame: Changes from baseline to week-12
measure: The Work and Social Adjustment Scale (WSAS)
timeFrame: Changes from baseline to week-12
measure: EuroQol-5 Dimensions EQ5-D
timeFrame: Changes from baseline to week-12
measure: Client Service Receipt Inventory (CSRI):
timeFrame: Changes from baseline to week-12
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Institute of Psychiatry
state: Punjab
city: Karachi
country: Pakistan
facility: Civil Hospital
state: Sindh
Study officials:
affiliation: Centre for Addiciton and Mental Health
name: Omair Husain, MD
role: PRINCIPAL_INVESTIGATOR
References: