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

NCT05567575 | Recruiting DMC

• 1 other identifier: TechCare-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Psychosis

Keywords

Psychosis; mHealth; Techonology; LMICs

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (6)

• Positive and Negative Syndrome Scale

  Changes from baseline to week-12

• Psychotic Symptom Rating Scales (PSYRATS)

  Changes from baseline to week-12

• Calgary Depression Scale (CDS)

  Changes from baseline to week-12

• The Work and Social Adjustment Scale (WSAS)

  Changes from baseline to week-12

• EuroQol-5 Dimensions EQ5-D

  Changes from baseline to week-12

Study Arms (2)

TechCare

EXPERIMENTAL

Participants in this arm will receive a mobile app based cognitive behavior therapy informed "TechCare" intervention for a period of 12 weeks.

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.

Behavioral: Cognitive Behavioral Therapy,

Interventions

Cognitive Behavioral Therapy, BEHAVIORAL

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).

Also known as: Mobile Health

TechCare; Wait-List control group:

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• unable to use simple functions of an android phone

Sponsors & Collaborators

• Pakistan Institute of Living and Learning: lead

Study Sites (2)

Institute of Psychiatry

Rawalpindi, Punjab Province, Pakistan

RECRUITING

Civil Hospital

Karachi, Sindh, 75500, Pakistan

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Cognitive Behavioral Therapy; Telemedicine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Omair Husain, MD

  Centre for Addiciton and Mental Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ameer B Khoso, Mphil

CONTACT

02135871845; ameer.bukhsh@pill.org.pk

Zaib un Nisa, Mphil

CONTACT

02135871845; zaibunnisa@pill.org.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Researchers doing outcome assessments will be kept masked of the treatment allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2022
• First Posted: October 5, 2022
• Study Start: October 1, 2022
• Primary Completion: December 30, 2024
• Study Completion: July 31, 2025
• Last Updated: May 17, 2024

Record last verified: 2024-05

Locations

PA (2)