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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06377709
Other study ID # 24CP001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 13, 2024
Est. completion date December 2024

Study information

Verified date June 2024
Source Nottingham University Hospitals NHS Trust
Contact Laura Shepherd
Phone 01159691169
Email Laura.shepherd@nuh.nhs.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United Kingdom Nottingham University Hospitals NHS Trust Nottingham

Sponsors (1)

Lead Sponsor Collaborator
Nottingham University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (5)

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Positive and Negative Affect Schedule (PANAS-GEN) A 20-item standardised measure of positive and negative affect. Responses to items are scored between 1 and 5. Ten items relate to positive affect and 10 items relate to negative affect. Scores range from 10 to 50 for both sets of items. For the total positive score, a higher score indicates more positive affect. For the total negative score, a lower score indicates less negative affect. The total score is calculated by the sum of the 10 positive items and then the 10 negative items. 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 Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT) A 23-item self-report questionnaire that measures psychological flexibility. Responses to each item fall on a scale between 0 and 6. The total score is used, ranging from 0 to 138. Three subscale scores can also be generated. Higher scores indicate greater psychological flexibility. 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 Self-Compassion Scale - Short Form (SCS-SF) A 12-item self-report questionnaire that measures self-compassion. Responses to items fall on a scale between 1 and 5. The total mean score is used, with values ranging between 1 and 5. Higher scores indicate higher self-compassion. 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 Helpful Aspects of Therapy Form (HAT) A seven-item self-report questionnaire that gathers mainly qualitative data about helpful and hindering aspects of therapy sessions. As soon as is feasible before and after the intervention. The post-intervention measure will be completed within one week of the intervention ending
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