ACT for Distress in Head and Neck Cancer Patients
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|ClinicalTrials.gov Identifier: NCT02840071|
Recruitment Status : Unknown
Verified July 2016 by University of Nottingham.
Recruitment status was: Not yet recruiting
First Posted : July 21, 2016
Last Update Posted : July 21, 2016
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:
- Is there evidence of psychological change after the introduction of the ACT intervention?
- 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 or disease||Intervention/treatment||Phase|
|Anxiety Depression||Other: Psychological therapy||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Acceptance and Commitment Therapy for Individuals With Head and Neck Cancer Experiencing Psychological Distress: A Hermeneutic Single-Case Efficacy Design|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||March 2017|
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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840071
|Contact: Thomas Schroder, Psychology||0115 854 firstname.lastname@example.org|
|Contact: Nicolle L Morris, Psychologyemail@example.com|
|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 firstname.lastname@example.org|
|Contact: Nicolle L Morris, Psychology 07482247324 email@example.com|
|Principal Investigator:||Thomas Schroder, Psychology||University of Nottingham|