A Mixed-methods Acceptability Study of ProACTive to Help Burns Patients Adjust to Changes to Appearance

NCT06377709 | Completed

• 1 other identifier: 24CP001
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Burn Injuries; Burns; Emotional Distress; Adjustment

Outcome Measures

Primary Outcomes (1)

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

  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).

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

Secondary Outcomes (4)

• 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

• 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

• 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

Study Arms (1)

ProACTive intervention

EXPERIMENTAL

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

Other: ProACTive

Interventions

ProACTive OTHER

ProACTive intervention, a talking therapy utilising acceptance and commitment therapy (ACT) techniques.

ProACTive intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead

Study Sites (1)

Nottingham University Hospitals NHS Trust

Nottingham, NG7 2UH, United Kingdom

Location

Related Publications (5)

• Mendelson BK, Mendelson MJ, White DR. Body-esteem scale for adolescents and adults. J Pers Assess. 2001 Feb;76(1):90-106. doi: 10.1207/S15327752JPA7601_6.

  PMID: 11206302 BACKGROUND

• Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.

  PMID: 21584907 BACKGROUND

• Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.

  PMID: 3397865 BACKGROUND

• Llewelyn SP. Psychological therapy as viewed by clients and therapists. Br J Clin Psychol. 1988 Sep;27(3):223-37. doi: 10.1111/j.2044-8260.1988.tb00779.x.

  PMID: 3191302 BACKGROUND

• Francis, A. W., Dawson, D. L., & Golijani-Moghaddam, N. (2016). The development and validation of the Comprehensive Assessment of Acceptance and Commitment Therapy processes (CompACT). Journal of Contextual Behavioral Science, 5(3), 134-145.

  BACKGROUND

MeSH Terms

Conditions

Burns

Interventions

Coping Skills

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 22, 2024
• Study Start: June 13, 2024
• Primary Completion: March 5, 2025
• Study Completion: March 5, 2025
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Acceptance of manuscript for publication.
• Access Criteria: The data will be made publicly available on the Open Science Framework upon acceptance of the manuscript for publication.

Locations

GB (1)