ACT for Distress in Head and Neck Cancer Patients

NCT02840071 | Unknown DMC

• 1 other identifier: 16067
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief Summary

Title: Acceptance and Commitment therapy for Individuals with Head and Neck Cancer Experiencing Psychological Distress. Head and neck cancer (HNC) patients are particularly vulnerable to experiencing psychological distress . The current guidelines from the National Institute of Health and Care Excellence are that cognitive-behavioural therapy (CBT) is to be offered to adults with a long-term physical health condition experiencing anxiety and depression. CBT has been shown to have several inadequacies for individuals with physical health conditions such as cancer. Acceptance and commitment therapy (ACT) takes an alternative approach to CBT, aiming to change a person's interaction with their thoughts rather than suppress or alter thought content. Although studies indicate encouraging findings for the effectiveness of ACT for individuals with breast cancer; the HNC- transfer-ability of findings is yet untested, and there is a need to evaluate the replicability of ACT effects in people living with HNC, given the unique challenges inherent to the disease and its treatment. This study aims to inform clinical practise by using a hermeneutic single-case efficacy design (HSCED) to answer the following questions:

1. 1.Is there evidence of psychological change after the introduction of the ACT intervention?
2. 2.If present, are the changes attributable to (a) ACT components, (b) common factors, and/or (c) non-therapeutic factors?

Conditions

Anxiety; Depression

Outcome Measures

Primary Outcomes (2)

• Change in psychological flexibility assessed using the Acceptance and Action Questionnaire (AAQ-II)

  The primary goal of ACT is increasing psychological flexibility by enabling a person to change their relationship with distressing cognitions (acceptance) and do things that are personally meaningful to them (commit). The primary outcome will be an assessment of whether change has occurred using process measures (acceptance and action questionnaire: AAQ-II).

  up to 18 weeks

• Change in psychological flexibility assessed using the Problem Questionnaire (PQ)

  Changes in the problem questionnaire (PQ) (administered pre and post intervention) will also be used as an indirect measure of change in psychological flexibility. This measure consists of up to 10 unique problem statements that the individual has, rated on a 7-point likert scale. Significant reductions in these ratings would indicate an increase in psychological flexibility.

  up to 18 weeks

Secondary Outcomes (2)

• Depression assessed by PHQ-9 questionnaire

  up to 18 weeks

• Anxiety assessed by GAD-7 questionnaire

  up to 18 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

Psychological therapy.

Other: Psychological therapy

Interventions

Psychological therapy OTHER

Acceptance and commitment therapy is a third-wave cognitive behavioural therapy. The aim of ACT intervention is to increase a person's psychological flexibility by enabling them to change their relationship with distressing cognitions (acceptance) and doing things that are personally meaningful to them (commitment). The ACT model does not focus on distress reduction, although this is a secondary consequence of acceptance and commitment. This is targeted through the six core processes: present moment awareness, cognitive defusion, acceptance, self-as-context, values and committed action which means taking effective action, guided by the identified values. The intervention will involve six 1.5 hourly individual sessions.

Intervention

Eligibility Criteria

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

You may qualify if:

• Participants taking part must:
• Be above the age of 18
• Have capacity to give informed consent (assessed by the clinical psychologist within the service)
• Able to understand and speak the English language
• Have a diagnosis head and neck cancer
• Experiencing psychological distress (assessed using anxiety and depression screening tools)
• Have the ability to attend relevant hospital for study participation

You may not qualify if:

• N/A see above

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (2)

City Hospital

Nottingham, Notitnghamshire, NG51PB, United Kingdom

Location

King's Mill Hospital

Mansfield, Nottinghamshire, NG174JL, United Kingdom

Location

Related Publications (9)

• Elliott R. Hermeneutic single-case efficacy design. Psychother Res. 2002 Mar 1;12(1):1-21. doi: 10.1080/713869614.

  PMID: 22471329 BACKGROUND

• Frampton M. Psychological distress in patients with head and neck cancer: review. Br J Oral Maxillofac Surg. 2001 Feb;39(1):67-70. doi: 10.1054/bjom.2000.0547.

  PMID: 11178847 BACKGROUND

• Hayes SC, Luoma JB, Bond FW, Masuda A, Lillis J. Acceptance and commitment therapy: model, processes and outcomes. Behav Res Ther. 2006 Jan;44(1):1-25. doi: 10.1016/j.brat.2005.06.006.

  PMID: 16300724 BACKGROUND

• Hulbert-Williams NJ, Storey L, Wilson KG. Psychological interventions for patients with cancer: psychological flexibility and the potential utility of Acceptance and Commitment Therapy. Eur J Cancer Care (Engl). 2015;24(1):15-27. doi: 10.1111/ecc.12223. Epub 2014 Aug 6.

  PMID: 25100576 BACKGROUND

• Lang H, France E, Williams B, Humphris G, Wells M. The psychological experience of living with head and neck cancer: a systematic review and meta-synthesis. Psychooncology. 2013 Dec;22(12):2648-63. doi: 10.1002/pon.3343. Epub 2013 Jul 10.

  PMID: 23840037 BACKGROUND

• Ost LG. Efficacy of the third wave of behavioral therapies: a systematic review and meta-analysis. Behav Res Ther. 2008 Mar;46(3):296-321. doi: 10.1016/j.brat.2007.12.005. Epub 2007 Dec 23.

  PMID: 18258216 BACKGROUND

• Ost LG. The efficacy of Acceptance and Commitment Therapy: an updated systematic review and meta-analysis. Behav Res Ther. 2014 Oct;61:105-21. doi: 10.1016/j.brat.2014.07.018. Epub 2014 Aug 19.

  PMID: 25193001 BACKGROUND

• Vilardaga R, Bricker J, McDonell M. The promise of mobile technologies and single case designs for the study of individuals in their natural environment. J Contextual Behav Sci. 2014 Apr 1;3(2):148-153. doi: 10.1016/j.jcbs.2014.03.003.

  PMID: 24949285 BACKGROUND

• Ruiz FJ. A Review of Acceptance and Commitment Therapy (ACT) Empirical Evidence : Correlational , Experimental Psychopathology , Component and Outcome Studies. International Journal of Psychology and Psychological Therapy 10(1): 125-162, 2010

  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Thomas Schroder, Psychology

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Schroder, Psychology

CONTACT

0115 854 2225; thomas.schroder@nottingham.ac.uk

Nicolle L Morris, Psychology

CONTACT

07482247324; msxnlm@nottingham.ac.uk

Study Design

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

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: July 21, 2016
• Study Start: October 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: July 21, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)