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Internet-delivered Acceptance and Commitment Therapy for Patients With Health Anxiety

Primary Purpose

Hypochondriasis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Internet-based ACT
Internet-based discussion forum
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypochondriasis focused on measuring Health anxiety, illness anxiety disorder, ACT, internet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Severe health anxiety > 6 months
  2. Whiteley-7 score (scale 0-100 score points) corresponding to 21,4 or more.
  3. Age above 18 years old
  4. In case of a comorbid functional or other psychiatric disorder health anxiety must be the dominant problem
  5. Patients who speak, read and write Danish
  6. Access to a computer and internet access
  7. Residence in Denmark

Exclusion criteria:

  1. Acute suicidal risk
  2. Abuse of narcotics or alcohol and (non-prescribed) medicine
  3. Lifetime-diagnosis of psychoses, bipolar affective disorder or depression with psychotic symptoms (ICD-10: F20-29, F30-31, F32.3, F33.3)
  4. Pregnancy
  5. Unstable psychopharmacological treatment within last 2 months
  6. Former treatment at the Research Clinic for Functional Disorders and Psychosomatics
  7. Not providing informed consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Internet-based ACT

    Internet-based discussion forum

    Arm Description

    Brief clinical psychiatric assessment to determine eligibility (video-based).

    Brief clinical psychiatric assessment to determine eligibility (video-based).

    Outcomes

    Primary Outcome Measures

    Whiteley-7 index
    Health anxiety symptoms

    Secondary Outcome Measures

    Demographic questions measured with questions from the Danish study for Functional Disorders (DanFund)
    Diagnosed somatic illnesses measured with questions from the Danish study for Functional Disorders (DanFund)
    Quality of life measured with the World Health Organisation Well-being Index-Five (WHO-5)
    Quality of life measured with the visual analogue scale (VAS question) from Youth profile, National Institute of Public Health
    Stress measured with questions from the survey Youth stress, Danish Health Authority
    Health anxiety symptoms measured with the Short Health Anxiety Inventory (SHAI)
    Anxiety, depression, obsessive-compulsive and physical symptoms measured with subscales from the Symptom Checklist (SCL-92)
    Somatisation measured with the Bodily Distress Syndrome Checklist (BDS Checklist)
    General health status and functioning measured with the Short Form 12 Health Survey (SF-12)

    Full Information

    First Posted
    April 1, 2016
    Last Updated
    April 27, 2021
    Sponsor
    University of Aarhus
    Collaborators
    Aarhus University Hospital, Karolinska Institutet
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02735434
    Brief Title
    Internet-delivered Acceptance and Commitment Therapy for Patients With Health Anxiety
    Official Title
    Internet-delivered Acceptance and Commitment Therapy for Patients With Health Anxiety: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2016 (Actual)
    Primary Completion Date
    April 2017 (Actual)
    Study Completion Date
    March 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Aarhus
    Collaborators
    Aarhus University Hospital, Karolinska Institutet

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Health anxiety is a prevalent, disabling disorder associated with extensive health care expenditures. The lack of easily accessible, evidence-based psychological treatment combined with delayed diagnostic recognition constitute barriers to receiving treatment. Aim To develop an internet-delivered treatment program, based on 'Acceptance and Commitment Therapy' (ACT), for patients with health anxiety. To test the feasibility and effectiveness of the treatment programme in a randomized, controlled trial, comparing the treatment with an active control condition. Methods 150 patients aged 18 years and older can self-refer through a web-page to apply for participation. Before inclusion patients will undergo a video-diagnostic interview. Patients are randomly assigned to 12 weeks of either, 1) active treatment: consisting of internet-based ACT (iACT) with 7 therapist-guided modules of self-help text, exercises, patient videos and audio-files, or 2) active control condition: consisting of an internet-based discussion forum (iFORUM) with 7 topics of discussion. All patients will complete self-report questionnaires at baseline, before randomization, at 4 and 8 weeks into treatment, after end of treatment, and at 6-month follow-up.
    Detailed Description
    Severe health anxiety (illness anxiety disorder) or hypochondriasis, according to the psychiatric classification system ICD-10, is characterized by preoccupation with fear of having a serious illness, which interferes with daily functions and persists despite medical reassurance. Clinical significant health anxiety is prevalent in primary care with 0.8-9.5%, and has a lifetime prevalence of 5.7% in the general population. It is a disabling disorder, associated with extensive use of health care services and occupational disability. Earlier, health anxiety has been considered a chronic disease with poor treatment outcomes. A recent review found effect of both medicine and psychotherapy, but patients may prefer psychotherapeutic treatments. Despite the high prevalence, health anxiety is rarely diagnosed within primary care, and there is limited access to evidence-based treatment for health anxiety. An easily accessible, evidence-based treatment is needed for this debilitating condition. Internet-based treatment is a new approach where patients receive access to a guided self-help program. A meta-analysis has shown equal treatment effects of internet-based treatment compared to "face-to-face" treatment for depressive- and anxiety disorders. Internet-based cognitive behavioral therapy for health anxiety has shown to be cost-effective. ACT is a new effective generation of cognitive-behavioral therapy, with an emphasis on acceptance and value-based exposure that has shown good results for treating health anxiety in a group setting. Internet-based Cognitive behavioral therapy (CBT) for health anxiety has shown promising results but low treatment completion. This may be due to the comprehensive treatment modules and the text-based format. ACT is an experiential behavioral therapy, and aims to activate patients with exercises, videos, audio-files and less text material. Most persons with health anxiety have high health care expenditure. However, some patients with health anxiety avoid contact to the health care system, and may not receive proper treatment. Patient self-referral is a new approach that may facilitate access to treatment. Aim To develop an internet-delivered treatment program for patients suffering from health anxiety based on ACT. To test the feasibility and effectiveness of the treatment programme in a randomized, controlled trial, comparing treatment with an active control condition. Hypothesis Primary hypothesis Patients with health anxiety treated with iACT will at 6-month follow-up report a significant reduction in illness worry compared to the action control condition iFORUM. Secondary hypotheses Patients with health anxiety treated with iACT compared to the active control condition iFORUM will at 6-month follow-up report: a reduction in physical symptoms and symptoms of anxiety and depression increased health-related quality of life more expedient illness perceptions and increased acceptance of symptoms Mediation analyses changes in illness perception and acceptance mediate the effect of iACT

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypochondriasis
    Keywords
    Health anxiety, illness anxiety disorder, ACT, internet

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    101 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Internet-based ACT
    Arm Type
    Experimental
    Arm Description
    Brief clinical psychiatric assessment to determine eligibility (video-based).
    Arm Title
    Internet-based discussion forum
    Arm Type
    Active Comparator
    Arm Description
    Brief clinical psychiatric assessment to determine eligibility (video-based).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Internet-based ACT
    Intervention Description
    The guided internet program consists of 7 modules activated consecutively over a period of 12 weeks. The content is written psycho education, patient videos, audio-exercises and behavioural exposure exercises. The program is therapist-guided; hence all patients will receive support from primarily the same therapist during the 12 weeks.
    Intervention Type
    Other
    Intervention Name(s)
    Internet-based discussion forum
    Intervention Description
    The online discussion forum consists of 7 themes touching upon the impact of health anxiety and the patients own coping strategies. The themes are activated consecutively over a period of 12 weeks. The discussion forum is text-based, and only patients will participate in the discussion. The written discussions will be reviewed by a professional for ethical reasons. The discussion forum aims to control for the effect of attention and contacts to the health care system. After 9 months patients in the discussion forum are offered active treatment, but not as part of the research project.
    Primary Outcome Measure Information:
    Title
    Whiteley-7 index
    Description
    Health anxiety symptoms
    Time Frame
    At baseline (i.e. at self-referral), before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline) and 1, 2, 3 and 9 months after randomisation
    Secondary Outcome Measure Information:
    Title
    Demographic questions measured with questions from the Danish study for Functional Disorders (DanFund)
    Time Frame
    At baseline (i.e. at self-referral)
    Title
    Diagnosed somatic illnesses measured with questions from the Danish study for Functional Disorders (DanFund)
    Time Frame
    At baseline (i.e. at self-referral)
    Title
    Quality of life measured with the World Health Organisation Well-being Index-Five (WHO-5)
    Time Frame
    At baseline (i.e. at self-referral), before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline) and 1, 2, 3 and 9 months after randomisation
    Title
    Quality of life measured with the visual analogue scale (VAS question) from Youth profile, National Institute of Public Health
    Time Frame
    At baseline (i.e. at self-referral), before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline) and 1, 2, 3 and 9 months after randomisation
    Title
    Stress measured with questions from the survey Youth stress, Danish Health Authority
    Time Frame
    At baseline (i.e. at self-referral), before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline) and 1, 2, 3 and 9 months after randomisation
    Title
    Health anxiety symptoms measured with the Short Health Anxiety Inventory (SHAI)
    Time Frame
    At baseline (i.e. at self-referral), and 3 and 9 months after randomisation
    Title
    Anxiety, depression, obsessive-compulsive and physical symptoms measured with subscales from the Symptom Checklist (SCL-92)
    Time Frame
    At baseline (i.e. at self-referral), and 3 and 9 months after randomisation
    Title
    Somatisation measured with the Bodily Distress Syndrome Checklist (BDS Checklist)
    Time Frame
    At baseline (i.e. at self-referral)
    Title
    General health status and functioning measured with the Short Form 12 Health Survey (SF-12)
    Time Frame
    At baseline (i.e. at self-referral), before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline), 3 and 9 months after randomisation
    Other Pre-specified Outcome Measures:
    Title
    Psychological flexibility measured with the Acceptance and Action Questionnaire-II (AAQ-II)
    Time Frame
    At baseline (i.e. at self-referral), and 1, 2, 3 and 9 months after randomisation
    Title
    Non-reactivity measured with a subscale of the Five Facet Mindfulness Questionnaire (FFMQ)
    Time Frame
    At baseline (i.e. at self-referral), and 1, 2, 3 and 9 months after randomisation
    Title
    Illness perception measured with the Brief Illness Perception Questionnaire (B-IPQ)
    Time Frame
    At baseline (i.e. at self-referral), and 1, 2, 3 and 9 months after randomisation
    Title
    Personality traits measured with the short version of the Big Five Inventory (BFI-10)
    Time Frame
    Before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline)
    Title
    Working alliance measured with the Working Alliance Inventory, Patient version (WAI-pt)
    Time Frame
    2 weeks into treatment, and 3 months after randomisation
    Title
    Treatment credibility and expectancy measured with the credibility/ expectancy questionnaire
    Time Frame
    Before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline)
    Title
    Childhood history questionnaire
    Time Frame
    Before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline)
    Title
    Traumatic events in childhood measured with the Childhood traumatic event scale
    Time Frame
    Before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline)
    Title
    Attachment style measured with the questionnaire: Experiences in close relationships - relationship structures (ECR-RS)
    Time Frame
    Before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline)
    Title
    Treatment evaluation of negative effects measured with the Inventory for the assessment of negative effects of psychotherapy (INEP)
    Time Frame
    9 months after randomisation
    Title
    Attitudes toward seeking professional help
    Time Frame
    At baseline (i.e. at self-referral) and at 3 months after randomisation
    Title
    Self-reported health care use, work performance and work absence measured with Trimbos/ institute of Health Policy and Management (iMTA) questionnaire for Costs associated with Psychiatric Illness (TiC-P)
    Time Frame
    At baseline (i.e. at self-referral) and at 9 months after randomisation
    Title
    Health care expenditures extracted from Danish national registers, and degree of illness related absence from work extracted from the Danish Register of Sickness absence compensation benefits and Social transfer payments database (DREAM).
    Time Frame
    At baseline (i.e. at self-referral) and at 9 months after randomisation
    Title
    Health literacy measured with the Health Literacy Questionnaire (HLQ)
    Time Frame
    At baseline (i.e. at self-referral)
    Title
    Values measured with the Sources of Meaning and Meaning in life questionnaire (SoMe-26)
    Time Frame
    At baseline (i.e. at self-referral), and 1, 2, 3 and 9 months after randomisation
    Title
    Negative events and effects of psychological treatment
    Time Frame
    At 3 months after randomisation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Severe health anxiety > 6 months Whiteley-7 score (scale 0-100 score points) corresponding to 21,4 or more. Age above 18 years old In case of a comorbid functional or other psychiatric disorder health anxiety must be the dominant problem Patients who speak, read and write Danish Access to a computer and internet access Residence in Denmark Exclusion criteria: Acute suicidal risk Abuse of narcotics or alcohol and (non-prescribed) medicine Lifetime-diagnosis of psychoses, bipolar affective disorder or depression with psychotic symptoms (ICD-10: F20-29, F30-31, F32.3, F33.3) Pregnancy Unstable psychopharmacological treatment within last 2 months Former treatment at the Research Clinic for Functional Disorders and Psychosomatics Not providing informed consent
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lisbeth Frostholm, PhD
    Organizational Affiliation
    Aarhus University Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Charlotte U Rask, PhD
    Organizational Affiliation
    Aarhus University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34997899
    Citation
    Risor BW, Frydendal DH, Villemoes MK, Nielsen CP, Rask CU, Frostholm L. Cost Effectiveness of Internet-Delivered Acceptance and Commitment Therapy for Patients with Severe Health Anxiety: A Randomised Controlled Trial. Pharmacoecon Open. 2022 Mar;6(2):179-192. doi: 10.1007/s41669-021-00319-x. Epub 2022 Jan 8.
    Results Reference
    derived
    PubMed Identifier
    32404226
    Citation
    Hoffmann D, Rask CU, Hedman-Lagerlof E, Jensen JS, Frostholm L. Efficacy of internet-delivered acceptance and commitment therapy for severe health anxiety: results from a randomized, controlled trial. Psychol Med. 2021 Nov;51(15):2685-2695. doi: 10.1017/S0033291720001312. Epub 2020 May 14.
    Results Reference
    derived
    PubMed Identifier
    31496462
    Citation
    Hoffmann D, Rask CU, Hedman-Lagerlof E, Eilenberg T, Frostholm L. Accuracy of self-referral in health anxiety: comparison of patients self-referring to internet-delivered treatment versus patients clinician-referred to face-to-face treatment. BJPsych Open. 2019 Sep 9;5(5):e80. doi: 10.1192/bjo.2019.54.
    Results Reference
    derived
    Links:
    URL
    http://www.functionaldisorders.dk
    Description
    Homepage for the Research Clinic for Functional Disorders, Aarhus University Hospital

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