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

NCT02735434 | Completed DMC

• 1 other identifier: 09032016
• Study Type: interventional
• Target: 101
• Locations: 0 countries
• Sites: N/A

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

1. 1.To develop an internet-delivered treatment program, based on 'Acceptance and Commitment Therapy' (ACT), for patients with health anxiety.
2. 2.To test the feasibility and effectiveness of the treatment programme in a randomized, controlled trial, comparing the treatment with an active control condition.

Conditions

Hypochondriasis

Keywords

Health anxiety; illness anxiety disorder; ACT; internet

Outcome Measures

Primary Outcomes (1)

• Whiteley-7 index

  Health anxiety symptoms

  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 Outcomes (9)

• Demographic questions measured with questions from the Danish study for Functional Disorders (DanFund)

  At baseline (i.e. at self-referral)

• Diagnosed somatic illnesses measured with questions from the Danish study for Functional Disorders (DanFund)

  At baseline (i.e. at self-referral)

• Quality of life measured with the World Health Organisation Well-being Index-Five (WHO-5)

  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

• Quality of life measured with the visual analogue scale (VAS question) from Youth profile, National Institute of Public Health

  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

• Stress measured with questions from the survey Youth stress, Danish Health Authority

  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

Other Outcomes (16)

• Psychological flexibility measured with the Acceptance and Action Questionnaire-II (AAQ-II)

  At baseline (i.e. at self-referral), and 1, 2, 3 and 9 months after randomisation

• Non-reactivity measured with a subscale of the Five Facet Mindfulness Questionnaire (FFMQ)

  At baseline (i.e. at self-referral), and 1, 2, 3 and 9 months after randomisation

• Illness perception measured with the Brief Illness Perception Questionnaire (B-IPQ)

  At baseline (i.e. at self-referral), and 1, 2, 3 and 9 months after randomisation

Study Arms (2)

Internet-based ACT

EXPERIMENTAL

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

Behavioral: Internet-based ACT

Internet-based discussion forum

ACTIVE COMPARATOR

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

Other: Internet-based discussion forum

Interventions

Internet-based ACT BEHAVIORAL

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.

Internet-based ACT

Internet-based discussion forum OTHER

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.

Internet-based discussion forum

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator
• Karolinska Institutet: collaborator

Related Publications (3)

• 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.

  PMID: 34997899 DERIVED

• 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.

  PMID: 32404226 DERIVED

• 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.

  PMID: 31496462 DERIVED

Related Links

• Homepage for the Research Clinic for Functional Disorders, Aarhus University Hospital

MeSH Terms

Conditions

Hypochondriasis

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Study Officials

• Lisbeth Frostholm, PhD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

• Charlotte U Rask, PhD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 1, 2016
• First Posted: April 12, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: March 1, 2018
• Last Updated: April 30, 2021

Record last verified: 2017-03