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

Psychosis Clinical Trial

— TechCare  

Official title:

Culturally Adapted Cognitive Behavior Therapy (CBT) Informed Mobile-Application for First Episode Psychosis (FEP). A Feasibility Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05567575
• Other study ID #: TechCare-001
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: July 31, 2025

Study information

• Verified date: May 2024
• Source: Pakistan Institute of Living and Learning
• Contact: Ameer B Khoso, Mphil
• Phone: 02135871845
• Email: ameer.bukhsh[@]pill.org.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 31, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders

Intervention

Behavioral:
• Cognitive Behavioral Therapy,
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).

Locations

Country	Name	City	State
Pakistan	Civil Hospital	Karachi	Sindh
Pakistan	Institute of Psychiatry	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Pakistan Institute of Living and Learning

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%	From baseline to 3rd month (at the end of intervention)
Primary	Acceptability measure	Acceptability will be determined using participant feedback on the use of app	From baseline to 3rd month (at the end of intervention)
Secondary	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.	Changes from baseline to week-12
Secondary	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	Changes from baseline to week-12
Secondary	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.	Changes from baseline to week-12
Secondary	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).	Changes from baseline to week-12
Secondary	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).	Changes from baseline to week-12
Secondary	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.	Changes from baseline to week-12