Internet-based Exposure Therapy for Excessive Worry

NCT02331537 | Completed

• 1 other identifier: 2014-1944-31-5
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine if an internet-based exposure therapy is effective in reducing excessive worry amongst patients who suffer from this problem.

Conditions

Excessive Worry; Rumination

Outcome Measures

Primary Outcomes (1)

• Penn State Worry Questionnaire (PSWQ)

  Change in worry from baseline to Week 10, and at 4- and 12 months after treatment has ended.

  Week 0, Week 10, Long term follow-up at 4-, and 12-months after treatment has ended

Secondary Outcomes (8)

• Meta Cognitions Questionnaire (MCQ-30)

  Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended

• Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S)

  Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended

• Euroqol (EQ-5D)

  Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended

• Hospital anxiety and depression scale (HADS)

  Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended

• Spontaneous Use of Imagery Scale (SUIS)

  Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended

Study Arms (2)

Internet-based cognitive-behavior therapy

EXPERIMENTAL

The experimental group will go through active internet-based treatment. The treatment is 10 weeks long and is based on the principles of exposure i.e. the participant is instructed to stay with the frightening thought until it is no longer associated with anxiety.

Behavioral: Internet-based cognitive-behavior therapy

Waitlist

NO INTERVENTION

Waitlist control that will get the internet-based treatment when the first group has finished (i.e. Week 10). There are no active treatment for these participants at all.

Interventions

Internet-based cognitive-behavior therapy BEHAVIORAL

Internet-based cognitive-behavior therapy on a safe internet platform. Treatment is divided into seven modules, each containing homework assignments . The participants will be assigned a therapist that they can contact through a message system in the platform and expect answer within 24 hours.

Internet-based cognitive-behavior therapy

Eligibility Criteria

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

You may qualify if:

• Outpatients
• ≥ 18 years
• Situated in Sweden
• Informed consent
• Penn State Worry Questionnaire score more than 56 points

You may not qualify if:

• Substance dependence during the last six months
• Post traumatic stress disorder, bipolar disorder or psychosis
• Symptoms better explained by axis 2 diagnosis (e.g. autism or borderline personality disorder)
• MADRS-S score above 25 points
• Psychotropic medication changes within two months prior to treatment that could affect target symptoms.
• Received exposure based Cognitive behavior therapy (CBT) for pathological worry the last 2 years

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet

Stockholm, Stockholm County, 17177, Sweden

Location

MeSH Terms

Conditions

Rumination Syndrome

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Feeding and Eating Disorders; Mental Disorders

Study Officials

• Erik M Andersson, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, psychologist

Study Record Dates

• First Submitted: January 1, 2015
• First Posted: January 6, 2015
• Study Start: January 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: September 1, 2015

Record last verified: 2015-08

Locations

SE (1)