Internet-Based Exposure Therapy Vs. Stress-Management Training for Worry

NCT02638792 | Completed

• 1 other identifier: REPN 2015/1698-31/1
• Study Type: interventional
• Target: 311
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Excessive Worry

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 (weekly measurements), at 4 months follow up, 12 months follow up.

Secondary Outcomes (10)

• Montgomery Åsberg Depression Rating Scale (MADRS-S)

  Week 0, Week 10, 4 and 12 months follow-up

• Euroqol, EQ-5D

  Week 0, Week 10, 4 and 12 months follow-up

• Cognitive Avoidance Questionnaire (CAQ)

  Week 0, Week 10, at 4 and 12 months follow up and weekly during treatment

• Intolerance of uncertainty scale

  Week 0, Week 10, at 4 and 12 months follow-up, and weekly during treatment

• Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)

  Week 0, Week 10, 4 and 12 months follow-up

Other Outcomes (2)

• Treatment credibility scale

  Week 2

• Working alliance scale

  Week 5

Study Arms (3)

Internet-based exposure therapy

EXPERIMENTAL

The internet-based exposure therapy (I-ET) group receives a ten-week Internet-based CBT treatment, which is an extended version of the self-help book "Sluta älta och grubbla med kognitiv beteendeterapi" (How to quit worrying and ruminating with Cognitive behavior therapy) by licensed psychologist Olle Wadström (2007). The main focus of the book is to expose to the frightening word/image and refrain from using neutralizing thoughts. This is supposed to lead to the extinction of upsetting words/images.

Behavioral: Internet-based exposure therapy (I-ET)

Internet-based stress management therapy

ACTIVE COMPARATOR

The I-SMT group receives a ten-week Internet-based CBT treatment focused on stress and how to manage stressful situations. This protocol is based on current evidence based recommendations for worry and has shown to be effective when delivered via the internet for irritable bowel syndrome and hypochondric worries.

Behavioral: Internet-based stress management therapy

Waitlist

NO INTERVENTION

When the active treatment groups have finished treatment (W11), the WL group will be able to start active treatment and be assessed at post-treatment, and 4, 12 months later using the same questionnaires as the treatment group. The participants will be able to choose which treatment they receive i.e. no randomization.

Interventions

Internet-based exposure therapy (I-ET) BEHAVIORAL

The internet-based exposure therapy (I-ET) group receives a ten-week Internet-based CBT treatment, which is an extended version of the self-help book "Sluta älta och grubbla med kognitiv beteendeterapi" (How to quit worrying and ruminating with Cognitive behavior therapy) by licensed psychologist Olle Wadström (2007). The main focus of the book is to expose to the frightening word/image and refrain from using neutralizing thoughts. This is supposed to lead to the extinction of upsetting words/images.

Internet-based exposure therapy

Internet-based stress management therapy BEHAVIORAL

The I-SMT group receives a ten-week Internet-based CBT treatment focused on stress and how to manage stressful situations. This protocol is based on current evidence based recommendations for worry and has shown to be effective when delivered via the internet for irritable bowel syndrome and hypochondric worries.

Internet-based stress management 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
• PSWQ 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 CBT for pathological worry the last 2 years.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Intitutet

Stockholm, 17177, Sweden

Location

Study Officials

• Erik M Andersson, PhD, Psych.

  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, Lic. psychologist

Study Record Dates

• First Submitted: December 19, 2015
• First Posted: December 23, 2015
• Study Start: December 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: November 28, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)