Psychological Adjustment to Long-term (PAL) Physical Conditions: A Randomised Cross-over Feasibility Trial of a Self-guided App

King's College London

Status: Enrolling

Conditions: Chronic Disease; Depression, Anxiety

Treatments: Device: Orbi

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07099365

45014

Details and patient eligibility

About

This study is a two-arm, randomised controlled cross-over feasibility study with a nested, optional qualitative study. The intervention consists of a self-guided smartphone app (Orbi) based on cognitive behavioural therapy (CBT) principles, which is designed to support psychological adjustment in long-term physical conditions. Orbi is an app adaption of an existing, evidence-based web-based intervention COMPASS. The control condition consists of usual charity support (UCS) for the relevant long-term physical health conditions (LTCs). All charity support includes a helpline which can be accessed via telephone or email.

The goal of this trial is to evaluate the feasibility of Orbi and the main questions it aims to answer are:

1. Is Orbi a feasible and acceptable intervention for individuals experiencing psychological distress related to LTCs?
2. Which aspects of the Orbi app and the trial enhance or diminish participants' experiences?

Participants will:

• Be randomised and each participant has an equal (50 %) chance of being assigned either to the Orbi+UCS group or to UCS group alone for 12 weeks. After 12 weeks, they will be crossed over to the alternate condition for another 12 weeks
• Complete questionnaires to assess psychological distress and intervention engagement at baseline, 6 weeks, and 12 weeks.
• A subset of participants will be invited to take part in a nested, optional semi-structured interviews to explore their experiences using Orbi and participating in the study.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged ≥18-years
• Verbal and written proficiency in English
• United Kingdom resident (General Practitioner registered)
• Basic computer literacy
• Email address to register with Orbi
• Have a long-term physical health condition
• Are experiencing distress related to their long-term physical condition

Exclusion criteria

• Evidence of substance dependency, cognitive impairment, severe mental health conditions identified by adhering to usual care Improving Access to Psychological Therapies (IAPT) screening practices that are employed at assessment and triage
• Those with evidence of severe depression and/ or anxiety scoring over 6 on the Patient Health Questionnaire-4 (PHQ-4) eligibility questionnaire or scoring 1 or above on the eligibility Patient Health Questionnaire-9 (PHQ-9) suicide risk question
• Receiving active psychological treatment from psychologist/counsellor/therapist or online psychological intervention

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

60 participants in 2 patient groups

Orbi + Usual Charity Support (UCS)

Experimental group

Description:

Participants randomised to this condition receive access to a self-guided smartphone app (Orbi) based on cognitive behavioural therapy principles in addition to Usual Charity Support (Orbi + UCS) to support Psychological Adjustment in long-term physical conditions.

Treatment:

Device: Orbi

Usual Charity Support (UCS)

No Intervention group

Description:

Participants randomised to this condition access Usual Charity Support (UCS) for their long-term physical condition(s). Resources provided by the charities include supportive listening, online support groups, information resources and local community support groups.