An ACT Based Application for Young People With Type 1 Diabetes

NCT02526069 | Terminated

• 1 other identifier: 15-SS-0064
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

Study Objectives: This study aims to assess the feasibility and acceptability of an application utilising Acceptance and Commitment Therapy in young people with type 1 diabetes. Primary Research Questions: Is an ACT based application feasible and acceptable to young people with type 1 diabetes. Study Design: Patients will use the app for four weeks and then be invited to attend an interview discussing the acceptability, usability and feasibility of the app. Clinician's will also be invited to take part in a workshop where they interact with the app and provide feedback. Consent for will be obtained through the app. Additional consent for the recording of interviews will be obtained in paper format and stored in a secure locked cabinet at Edinburgh University. Quantitative data will also be collected on well-being, psychological flexibility, and data usage. Data Collection Qualitative feedback: Interviews will be recorded and transcribed using unique identifiers. Outcome measures and data usage patterns: Data will be collected on a password protected database which can only be obtained via a password protected and encrypted server from University of Edinburgh. Data Analysis: Phase 1: Framework analysis and interpretive phenomenological analysis will be utilised to create themes from the qualitative feedback.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Acceptability and feasibility of using SweetSpot

  Interviews will be conducted

  4 weeks

Secondary Outcomes (5)

• Change in Psychological Flexibility - Diabetes specific (DAAS)

  baseline, 4 weeks

• Change in Psychological Flexibility (AFQ-Y8)

  baseline, 4 weeks

• Change in Diabetes Related Distress (PAID-T)

  baseline, 4 weeks

• Change in Glucose Management

  baseline, 4 weeks

• Well-being

  baseline, 4 weeks

Other Outcomes (1)

• Change in Valued Living (BEVS)

  baseline, 4 weeks

Study Arms (1)

SweetSpot users

OTHER

Participants will interact with the smartphone application for as long or as little as they wish. They will be asked to complete questionnaires at baseline (pre), 4 weeks (post), and to attend an interview.

Behavioral: Acceptance and Commitment Therapy

Interventions

Acceptance and Commitment Therapy BEHAVIORAL

An application based on Acceptance and Commitment Therapy

SweetSpot users

Eligibility Criteria

• Age: 13 Years - 22 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• year olds diagnosed with type 1 diabetes or a clinician working in this field
• Understand English
• Android phone
• If a patient to have been diagnosed for at least 6 months
• Ability to give consent

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

University of Edinburgh

Edinburgh, EH8 9AG, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Estelle L Barker, MSc

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trainee Clinical Psychologist

Study Record Dates

• First Submitted: August 13, 2015
• First Posted: August 18, 2015
• Study Start: May 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 12, 2016

Record last verified: 2016-05

Locations

GB (1)