A Randomised Feasibility Trial With Internet Based Self-help Therapy (IBT)

October 11, 2016 updated by: Mental Health Services in the Capital Region, Denmark

Internet Based Self-help Therapy With FearFighter™ Versus no Intervention for Anxiety Disorders in Adult Persons: a Randomised Feasibility Trial

Background. In Denmark, about 350,000 persons suffer from anxiety. Public health-care services plan to implement internet based self-help psychotherapy (IBT) to be an important alternative and supplement to ordinary face-to-face therapy. Meta-analyses indicate that the effect of IBT for anxiety disorders seems better than no intervention, and in some instances equal to 'usual therapy'. But studies have been characterised by small sample sizes, high risk for bias, including high dropout.

Objective. The objective of this pilot trial is to assess the feasibility of conducting a larger confirmatory trial investigating the benefits and harms of an internet-based self-help therapy program, FearFighter™, compared with no intervention for persons with an anxiety disorder.

Design. An investigator-initiated feasibility randomised clinical trial investigating internet-based therapy with FearFighter™ compared with no intervention for persons with an anxiety disorder. We will include 64 participants.

Eligibility criteria. Inclusion criteria: age 18 or older; specific phobia, panic disorder, agoraphobia, or social phobia is the primary diagnosis according to the DSM-IV; and informed consent. Exclusion criteria: suicidal risk; ongoing episode of bipolar disorder or psychosis; concurrent psychological treatment for the anxiety disorder; unable to attend the intervention; or lack of informed consent.

Intervention. The intervention group will use the program FearFighter™, a nine session cognitive behavioural self-help therapy program delivered over the internet during nine weeks. The control group receive no intervention for nine weeks.

Outcomes. Feasibility outcomes are the fraction that are eligible, the fraction that are randomised, and the compliance in the intervention group. Clinical exploratory outcomes are: remission, Beck Anxiety Inventory, Symptom Check List-90R, WHO Well-Being Index, Sheehan Disability Scale, serious adverse events, and behaviour log from FearFighter.

Time schedule. Participants will be included in the trial from July 2015. Results are expected in February 2016.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Capital Region
      • Gentofte, Capital Region, Denmark, 2820
        • Psychotherapy Center Stolpegård, Mental Health Services in the Capital Region of Denmark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 or older.
  • Specific phobia, panic disorder, agoraphobia or social phobia is the primary diagnosis according to the DSM-IV
  • Written informed consent.

Exclusion Criteria:

  • Acute suicidal risk.
  • Ongoing episode of bipolar disorder or psychosis.
  • Receive concurrent psychological treatment for an anxiety disorder
  • Considered unable to attend IBT sessions as planned (due to vacation, work/study placement, sickness or similar occurrences).
  • Lack of informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FearFighter
The experimental group will use the program FearFighter™.
Behavioral: FearFighter
FearFighter™ is a nine session cognitive behavioural self-help therapy program delivered over the internet during nine weeks. Each session on FearFighter excluding the homework takes about 30-40 minutes to finish. A support person will make a weekly contact of 10 minutes in average to secure understanding of the program and compliance.
Other Names:
  • Internet based therapy
  • Computer assisted therapy
No Intervention: Control group
The control group receive no intervention for nine weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fractions of participants that are eligible and can be randomised
Time Frame: up to week 10
We will determine the fraction of potential participants as the number of eligible persons compared to the number of randomised persons. Here, we consider eligible participants' to be persons who fulfill the inclusion criteria. Exclusion criteria and informed consent is not included in this definition of eligibility.
up to week 10
Fraction of participants randomised to the experimental group that will comply with the experimental intervention
Time Frame: up to week 10
We will determine the fraction of participants randomised to the experimental group that will comply with the experimental intervention, defined as completing at least 6 of 9 FearFighter™ sessions during the intervention
up to week 10
Proportion of participants who fulfil the diagnostic criteria for an anxiety disorder at the end of the intervention measured with 'Mini International Neuropsychiatric Interview' (M.I.N.I.)
Time Frame: up to 37 weeks after start of intervention
Participants are diagnostic assessed with the 'Mini International Neuropsychiatric Interview' (M.I.N.I.), a short structured interview for the most important psychiatric axis 1 diagnoses in DSM-IV and in ICD-10.
up to 37 weeks after start of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptoms: Beck Anxiety Inventory (BAI)
Time Frame: Baseline, 10 weeks and 37 weeks after start of intervention
Beck Anxiety Inventory (BAI) is a 21-items general questionnaire for anxiety symptoms during the last 14 days.
Baseline, 10 weeks and 37 weeks after start of intervention
Symptoms: Symptom check list-90R (SCL-90R)
Time Frame: Baseline, 10 weeks and 37 weeks after start of intervention

Symptom check list-90R (SCL-90R) is a 90-item questionnaire measuring psychological distress and psychopathology (35). Within SCL-90R we use:

  • Global severity index (GSI);
  • Interpersonal sensitivity subscale;
  • Anxiety subscale; and
  • Phobic anxiety subscale.
Baseline, 10 weeks and 37 weeks after start of intervention
Functionality: Sheehan Disability Scale (SDS)
Time Frame: Baseline, 10 weeks and 37 weeks after start of intervention

Sheehan Disability Scale (SDS). We assess:

  • Occupational function;
  • Social function; and
  • Family function.
Baseline, 10 weeks and 37 weeks after start of intervention
Quality of life: WHO Well-Being Index
Time Frame: Baseline, 10 weeks and 37 weeks after start of intervention
WHO Well-Being Index.,We assess the quality of life.
Baseline, 10 weeks and 37 weeks after start of intervention
Serious adverse events (SAE)
Time Frame: SAE will be registrered throughout the intervention from week 0 to week 10

Serious adverse events, defined as any adverse event that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect.

Other adverse events, defined as any undesirable medical event occurring to a participant during a clinical trial, which does not necessarily have a causal relationship with the intervention.
SAE will be registrered throughout the intervention from week 0 to week 10

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behaviour log from FearFighter
Time Frame: Behaviour log will be registrered throughout the intervention from week 0 to week 10
Registration of the number of times the participant log on FearFighter.
Behaviour log will be registrered throughout the intervention from week 0 to week 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mental Health Services in the Capital Region, Denmark

Collaborators

TrygFonden, Denmark
Copenhagen Trial Unit, Center for Clinical Intervention Research
Student Counselling Service, Denmark

Investigators

  • Study Director: Marianne Lau, MD, Stolpegaard Psychotherapy Centre. Mental Health Services in the Capital Region of Denmark.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

July 1, 2015

First Submitted That Met QC Criteria

July 14, 2015

First Posted (Estimate)

July 15, 2015

Study Record Updates

Last Update Posted (Estimate)

October 12, 2016

Last Update Submitted That Met QC Criteria

October 11, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FearFighter-RHP2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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