A Randomised Feasibility Trial With Internet Based Self-help Therapy

NCT02499055 | Unknown DMC

• 1 other identifier: FearFighter-RHP2015
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Keywords

anxiety; behaviour therapy; computer assisted therapy; psychotherapy

Outcome Measures

Primary Outcomes (3)

• Fractions of participants that are eligible and can be randomised

  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

  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.)

  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 Outcomes (5)

• Symptoms: Beck Anxiety Inventory (BAI)

  Baseline, 10 weeks and 37 weeks after start of intervention

• Symptoms: Symptom check list-90R (SCL-90R)

  Baseline, 10 weeks and 37 weeks after start of intervention

• Functionality: Sheehan Disability Scale (SDS)

  Baseline, 10 weeks and 37 weeks after start of intervention

• Quality of life: WHO Well-Being Index

  Baseline, 10 weeks and 37 weeks after start of intervention

• Serious adverse events (SAE)

  SAE will be registrered throughout the intervention from week 0 to week 10

Other Outcomes (1)

• Behaviour log from FearFighter

  Behaviour log will be registrered throughout the intervention from week 0 to week 10

Study Arms (2)

FearFighter

EXPERIMENTAL

The experimental group will use the program FearFighter™.

Behavioral: FearFighter

Control group

NO INTERVENTION

The control group receive no intervention for nine weeks.

Interventions

FearFighter BEHAVIORAL

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.

Also known as: Internet based therapy, Computer assisted therapy

FearFighter

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead
• Copenhagen Trial Unit, Center for Clinical Intervention Research: collaborator
• TrygFonden, Denmark: collaborator
• Student Counselling Service, Denmark: collaborator

Study Sites (1)

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

Gentofte Municipality, Capital Region, 2820, Denmark

Location

Related Publications (2)

• Fenger M, Lindschou J, Gluud C, Winkel P, Jorgensen L, Dybkjaer JH, Lau M. Internet-based therapy with FearFighter for anxiety disorders: a randomised clinical trial. Nord J Psychiatry. 2020 Oct;74(7):518-524. doi: 10.1080/08039488.2020.1755363. Epub 2020 May 13.

  PMID: 32401099 DERIVED

• Fenger M, Lindschou J, Gluud C, Winkel P, Jorgensen L, Kruse-Blinkenberg S, Lau M. Internet-based self-help therapy with FearFighter versus no intervention for anxiety disorders in adults: study protocol for a randomised controlled trial. Trials. 2016 Oct 28;17(1):525. doi: 10.1186/s13063-016-1619-3.

  PMID: 27793181 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Therapy, Computer-Assisted

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Marianne Lau, MD

  Stolpegaard Psychotherapy Centre. Mental Health Services in the Capital Region of Denmark.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2015
• First Posted: July 15, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: October 12, 2016

Record last verified: 2016-10

Locations

DK (1)