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

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ClinicalTrials.gov Identifier: NCT02499055
Recruitment Status : Unknown
Verified October 2016 by Mental Health Services in the Capital Region, Denmark.
Recruitment status was:  Active, not recruiting
First Posted : July 15, 2015
Last Update Posted : October 12, 2016
Sponsor:
Collaborators:
Copenhagen Trial Unit, Center for Clinical Intervention Research
TrygFonden, Denmark
Student Counselling Service, Denmark
Information provided by (Responsible Party):
Mental Health Services in the Capital Region, Denmark

Tracking Information
First Submitted Date  ICMJE July 1, 2015
First Posted Date  ICMJE July 15, 2015
Last Update Posted Date October 12, 2016
Study Start Date  ICMJE August 2015
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2015)
  • 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.
  • 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
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2015)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 14, 2015)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Randomised Feasibility Trial With Internet Based Self-help Therapy
Official Title  ICMJE Internet Based Self-help Therapy With FearFighter™ Versus no Intervention for Anxiety Disorders in Adult Persons: a Randomised Feasibility Trial
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Anxiety
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: FearFighter
    The experimental group will use the program FearFighter™.
    Intervention: Behavioral: FearFighter
  • No Intervention: Control group
    The control group receive no intervention for nine weeks.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: July 14, 2015)
64
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02499055
Other Study ID Numbers  ICMJE FearFighter-RHP2015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mental Health Services in the Capital Region, Denmark
Study Sponsor  ICMJE Mental Health Services in the Capital Region, Denmark
Collaborators  ICMJE
  • Copenhagen Trial Unit, Center for Clinical Intervention Research
  • TrygFonden, Denmark
  • Student Counselling Service, Denmark
Investigators  ICMJE
Study Director: Marianne Lau, MD Stolpegaard Psychotherapy Centre. Mental Health Services in the Capital Region of Denmark.
PRS Account Mental Health Services in the Capital Region, Denmark
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP