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Clinical Trials/NCT06377709
NCT06377709CompletedNot Applicable

A Mixed-methods Acceptability Study of ProACTive, an Early Acceptance and Commitment Therapy Intervention to Help Burns Patients Adjust to Changes to Appearance

Nottingham University Hospitals NHS Trust1 site in 1 country13 target enrollmentStarted: June 13, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
13
Locations
1
Primary Endpoint
Body Esteem Scale for Adolescents and Adults - Appearance subscale (BESAA-A)

Study Overview

Brief Summary

This mixed-methods acceptability study aims to investigate whether an early acceptance and commitment therapy (ACT) based intervention called ProACTive, aimed at supporting burns patients' adjustment to a changed appearance and preventing distress, is acceptable. This will be measured by descriptive data, questionnaire data and semi-structured interviews.

Preliminary data on the potential clinical effectiveness of the intervention will also be gathered. This will be measured by scores on standardised questionnaires.

Detailed Description

Evidence suggests that appearance concerns after burn injuries start early. Appearance concerns can be chronic, create psychological distress and impact quality of life. No early psychological interventions for appearance concerns after burn injuries currently exist.

ProACTive, a novel psychological intervention (talking therapy), utilising acceptance and commitment therapy (ACT) techniques with an additional focus on developing self-compassion and social skills training, was developed. It aims to help burns patients adjust to changes to appearance and prevent distress. It involves up to five 30-minute modules and patients can select how many, and which, modules to complete. It is delivered by a psychological professional working in burns services.

The primary aim of this study is to explore whether the ProACTive intervention is acceptable to burns patients. A secondary objective is to gather preliminary data on the potential clinical effectiveness of the ProACTive intervention.

A mixed-methods single-arm acceptability study will be conducted.

ProACTive will be offered to burns patients (aged 18 years or over) meeting inclusion criteria and admitted to the burns service at Nottingham University Hospitals NHS Trust.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Adult patients (18 years and over) admitted as inpatients to the burns service with an acute burn injury

Exclusion Criteria

  • •Patients already receiving psychological input from the burns clinical psychology service for appearance related concerns, over and above supportive listening
  • •Patients admitted as inpatients to the burns service for reconstructive surgery, for a historical burn injury
  • •Patients who are too physically unwell to participate
  • •Patients deemed too psychologically unwell or in a mental health crisis by the usual clinical care team (for example, patients who sustained their burn injury due to a suicide attempt or self-harm, are currently having suicidal thoughts, or those with psychosis)
  • •Patients who are not fluent in the English language in order to participate
  • •Patients with a known cognitive impairment

Arms & Interventions

ProACTive intervention

Experimental

ProACTive intervention. Participants will choose how many, and which, modules to complete.

Intervention: ProACTive (Other)

Outcomes

Primary Outcomes

Body Esteem Scale for Adolescents and Adults - Appearance subscale (BESAA-A)

Time Frame: As soon as is feasible before and after the intervention. The post-intervention measure will be completed within one week of the intervention ending

A 10-item self-report questionnaire that measures appearance concerns/body esteem. Responses to each item fall on a scale between 0 and 4. The total mean score is used, falling between 0 and 4. Higher scores indicate higher appearance esteem (i.e. lower appearance concerns).

Secondary Outcomes

  • Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT)(As soon as is feasible before and after the intervention. The post-intervention measure will be completed within one week of the intervention ending)
  • Positive and Negative Affect Schedule (PANAS-GEN)(As soon as is feasible before and after the intervention. The post-intervention measure will be completed within one week of the intervention ending)
  • Self-Compassion Scale - Short Form (SCS-SF)(As soon as is feasible before and after the intervention. The post-intervention measure will be completed within one week of the intervention ending)
  • Helpful Aspects of Therapy Form (HAT)(As soon as is feasible before and after the intervention. The post-intervention measure will be completed within one week of the intervention ending)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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