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ACT for Distress in Head and Neck Cancer Patients

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2016 by University of Nottingham
Sponsor:
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT02840071
First received: July 12, 2016
Last updated: July 18, 2016
Last verified: July 2016
  Purpose

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

The study will involve recruiting three adults with HNC from specialist HNC psychology services. Each participant will have six individual sessions of ACT and complete various process and outcome questionnaires during sessions. Following the intervention, participants will have a semi-structured interview where their views of the therapy and any changes made will be explored. Two outcome measures will be posted to participants at 1-month and 3-month post intervention.


Condition Intervention
Anxiety
Depression
Other: Psychological therapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acceptance and Commitment Therapy for Individuals With Head and Neck Cancer Experiencing Psychological Distress: A Hermeneutic Single-Case Efficacy Design

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Change in psychological flexibility assessed using the Acceptance and Action Questionnaire (AAQ-II) [ Time Frame: up to 18 weeks ]
    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).

  • Change in psychological flexibility assessed using the Problem Questionnaire (PQ) [ Time Frame: up to 18 weeks ]
    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.


Secondary Outcome Measures:
  • Depression assessed by PHQ-9 questionnaire [ Time Frame: up to 18 weeks ]
    In line with the theoretical underpinnings of ACT, a secondary consequence of an increase in psychological flexibility is a reduction in psychological distress. The study will measure changes in psychological distress (depression) using PHQ-9 (patient health: depression questionnaire). A clinical caseness score (10 or above) is a threshold for clinical levels of depression. Analysis to identify statistically reliable change (pre and post intervention and follow up) will be carried out.

  • Anxiety assessed by GAD-7 questionnaire [ Time Frame: up to 18 weeks ]
    In line with the theoretical underpinnings of ACT, a secondary consequence of an increase in psychological flexibility is a reduction in psychological distress. The study will measure changes in psychological distress (anxiety) using GAD-7 (generalised anxiety disorder questionnaire). A clinical caseness score (8 or above) is a threshold for clinical levels of anxiety. Analysis to identify statistically reliable change (pre, post intervention and follow-up) will be used.


Estimated Enrollment: 3
Study Start Date: October 2016
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Psychological therapy.
Other: Psychological therapy
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A see above
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02840071

Contacts
Contact: Thomas Schroder, Psychology 0115 854 2225 thomas.schroder@nottingham.ac.uk
Contact: Nicolle L Morris, Psychology 07482247324 msxnlm@nottingham.ac.uk

Locations
United Kingdom
City Hospital Not yet recruiting
Nottingham, Notitnghamshire, United Kingdom, NG51PB
King's Mill Hospital Not yet recruiting
Mansfield, Nottinghamshire, United Kingdom, NG174JL
Contact: Dr Sanchia Biswas, Psychology    01623 622515 ext 6692    sanchia.biswas@nottshc.nhs.uk   
Contact: Nicolle L Morris, Psychology    07482247324    msxnlm@nottingham.ac.uk   
Sponsors and Collaborators
University of Nottingham
Investigators
Principal Investigator: Thomas Schroder, Psychology University of Nottingham
  More Information

Publications:
Holman G, Koerner K. Single case designs in clinical practice: A contemporary CBS perspective on why and how to. Journal of Contextual Behavioral Science 3(2): 138-147, 2014.
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

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT02840071     History of Changes
Other Study ID Numbers: 16067
Study First Received: July 12, 2016
Last Updated: July 18, 2016
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on May 25, 2017