Anxiety Self-management Intervention for Pulmonary Hypertension
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|ClinicalTrials.gov Identifier: NCT04450862|
Recruitment Status : Not yet recruiting
First Posted : June 30, 2020
Last Update Posted : June 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Hypertension Pulmonary Arterial Hypertension Anxiety Anxiety Disorders||Other: Cognitive Behavioural therapy self help intervention for anxiety||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomised controlled trial|
|Masking:||None (Open Label)|
|Official Title:||Development and Pilot Randomised Controlled Trial of a Self-management Intervention to Help Individuals With Pulmonary Hypertension Live Better With Anxiety|
|Estimated Study Start Date :||July 1, 2020|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||August 30, 2021|
Experimental: Intervention arm
Participants randomised to the intervention arm will receive a CBT informed, self-help intervention for anxiety in PH. This will be based on the four factor model, which is a trans-diagnostic approach to help understanding and identify behaviour change methods (Padesky & Mooney, 1990).
Other: Cognitive Behavioural therapy self help intervention for anxiety
The intervention will involve five key components:
Psychoeducation - Increase awareness of how PH may affect emotional health, normalisation of difficulties, and discussion of how symptoms associated with anxiety may add to the burden of the disease.
Cognitions - Identify and challenge negative automatic thoughts associated with anxiety.
Coping skills - Educate and practice a range of behavioural coping methods to help participants better manage their physical symptoms associated with anxiety in PH.
Exposure - Replace avoidance of anxiety provoking situations and activities using graded exposure.
Relapse prevention - Focus on relapse prevention with implementation intentions and promotion of problem solving.
No Intervention: Control arm
A waiting-list will be used as a control condition. If the self-management intervention is found to be acceptable and not associated with any risk, then participants in the control condition will receive the intervention.
- Change in Generalised Anxiety Disorder-7 (GAD-7) [ Time Frame: pre intervention, post intervention (4 weeks after) and 1 month follow up ]The Generalised Anxiety Disorder-7 (GAD-7) is a seven-item scale, self-administered screening tool and anxiety severity measure for anxiety disorders including, generalised anxiety disorder, social anxiety and panic disorder. Scores range from 0-21. A score of 0-4 indicates "no difficulties", 5-9 "mild", 10-14 "moderate" and 15-21 "severe" levels. A higher score suggests greater anxiety.
- Change in Patient Health Questionnaire-9 (PHQ9) [ Time Frame: pre intervention, post intervention (4 weeks after) and 1 month follow up ]The Patient Health Questionnaire-9 (PHQ9) is a nine-item, self-administered tool to examine severity of depression. Scores range from 0-27. A score of 0-4 indicates "no difficulties", 5-9 "mild", 10-14 "moderate", 15-19 "moderately severe" and 20 or higher "severe depression". A higher score suggests greater depression.
- Change in emPHasis-10 [ Time Frame: pre intervention, post intervention (4 weeks after) and 1 month follow up ]This is a disease-specific, health-related quality of life measure asking respondents to rate ten difficulties commonly associated with PH. Scores can range form 0-50, with a higher score indicating lower quality of life.
- Change in Dyspnoea 12 (D12) [ Time Frame: pre intervention, post intervention (4 weeks after) and 1 month follow up ]The Dyspnoea 12 (D12) will be used to examine participant's breathlessness severity. Total scores range from 0-36 with a higher score indicating worse functioning
- Change in Mastery Scale [ Time Frame: pre intervention, post intervention (4 weeks after) and 1 month follow up ]The Mastery Scale will be used to investigate participant's perception of their own ability of coping. Total scores range from 7-49 with a higher score suggesting the individual perceives himself or herself as having a greater capacity to cope
- Change in Cognitive Behavioural Processes Questionnaire (CBPQ) [ Time Frame: pre intervention, post intervention (4 weeks after) and 1 month follow up ]The Cognitive Behavioural Processes Questionnaire (CBPQ) will be used to examine participant's responses to negative cognitions, emotions and behaviours that may themselves underlie anxiety disorders. Scores range from 0-120, with higher scores suggesting lower engagement in cognitive and behavioural processes.
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): NCT04450862
|Contact: Gregg H Rawlings, PhD||(+44) (0)114 firstname.lastname@example.org|
|Contact: Amrit Sinha||0114 email@example.com|
|Clinical Psychology Unit|
|Sheffield, South Yorkshire, United Kingdom, S1 2LT|
|Principal Investigator:||Gregg H Rawlings, PhD||University of Sheffield|