NCT01963806

Brief Summary

BACKGROUND: Smartphone technology presents a novel and promising opportunity to extend the reach of psychotherapeutic interventions by moving selected parts of the therapy into the real-life situations causing distress. This randomised controlled trial will investigate the effect of a transdiagnostic, Internet-administered cognitive behavioural (iCBT) self-help program for anxiety, supplemented with a tailored smartphone application. The effect of added therapist support will also be studied. METHODS/DESIGN: 150 participants meeting diagnostic criteria for social anxiety disorder and/or panic disorder will be evenly randomised to one of three treatment arms: (1) smartphone-supplemented iCBT with therapist support; (2) smartphone-supplemented iCBT without therapist support; or (3) an active waiting list control group with delayed treatment. After the 10 week treatment period, the control group (3) will receive the same treatment as group (2). Primary outcome measure will be the Generalised Anxiety Disorder 7-item self-rating scale. Secondary measures include other anxiety, depression and quality of life measures. In addition to pre- and post-treatment measurements, the study includes two mid-treatment and two follow-up assessments (12 and 24 months). HYPOTHESES: Based on prior research, we hypothesise that the therapist-guided form will be superior to the unguided form in reducing anxiety levels, and that both delivery modes will be superior to an active waiting-list control group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 10, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 16, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

2.2 years

First QC Date

October 10, 2013

Last Update Submit

July 21, 2021

Conditions

Panic DisorderPhobic Disorders

Outcome Measures

Primary Outcomes (1)

  • The Generalised Anxiety Disorder 7-item (GAD-7)

    The Generalised Anxiety Disorder 7-item (GAD-7). The 7 items of the scales are rated 0-3 ("Not at all" to "Nearly every day") based on their occurrence within the last 2 weeks. Good internal consistency and factor structure has been reported.

    Change from baseline at: [1] day 24 and [2] day 48 into the 10-week treatment period; [3] 0-1 week after the treatment period; follow-ups at [4] month 12 and [5] month 36 after the treatment period.

Secondary Outcomes (4)

  • Self-rated Liebowitz Social Anxiety Scale (LSAS-SR)

    Change from baseline at: [1] 0-1 week after the treatment period; follow-ups at [2] month 12 and [3] month 36 after the treatment period.

  • Self-rated Panic Disorder Severity Scale (PDSS-SR)

    Change from baseline at: [1] 0-1 week after the treatment period; follow-ups at [2] month 12 and [3] month 36 after the treatment period.

  • 9-item Patient Health Questionnaire (PHQ-9)

    Change from baseline at: [1] day 24 and [2] day 48 into the 10-week treatment period; [3] 0-1 week after the treatment period; follow-ups at [4] month 12 and [5] month 36 after the treatment period.

  • Quality of Life Inventory (QOLI)

    Change from baseline at: [1] 0-1 week after the treatment period; follow-ups at [2] month 12 and [3] month 36 after the treatment period.

Study Arms (3)

Smartphone-supplemented iCBT with therapist support

EXPERIMENTAL

n = 50

Behavioral: Smartphone-supplemented iCBTBehavioral: Therapist support

Smartphone-supplemented iCBT without therapist support

EXPERIMENTAL

n = 50

Behavioral: Smartphone-supplemented iCBT

Active waiting list control group with delayed treatment

ACTIVE COMPARATOR

n = 50

Behavioral: Smartphone-supplemented iCBTOther: Active waiting list

Interventions

Smartphone-supplemented iCBTBEHAVIORAL

The Internet-administered cognitive behavioural self-help program (iCBT) will be divided into 10 weekly, progressively available modules covering CBT and Acceptance and Commitment Therapy (ACT) conceptualisations of anxiety disorders, as well as more specific therapeutic techniques such as cognitive restructuring, exposure training, attention and breathing exercises and relapse prevention . Each module also includes writing exercises. Also included is a tailored smartphone application. Briefly, the application allows the user to access, create and modify a personal database of behaviours and check-off these behaviours immediately when completed. Frequency of carried-out behaviours are recorded and displayed as statistics. The application also allows users to browse and search a database of behaviours uploaded by other study participants, providing both inspiration and a sense of social support.

Active waiting list control group with delayed treatmentSmartphone-supplemented iCBT with therapist supportSmartphone-supplemented iCBT without therapist support
Therapist supportBEHAVIORAL

The role of the therapists will be to provide feedback on the written exercises of each treatment module, as well as to provide support and encouragement. As a rule of thumb, the therapists will devote 15 minutes per participant and week.

Smartphone-supplemented iCBT with therapist support
Active waiting listOTHER

Completes measurements at day 24 and 48 and at the end of the initial treatment period, otherwise no activity until crossover.

Active waiting list control group with delayed treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Satisfy DSM-IV-TR criteria for panic disorder and/or social anxiety disorder as assessed by the SCID.
  • Daily access to the Internet via computer and smartphone
  • Residing in Sweden and speaking sufficient Swedish to communicate with the research team

You may not qualify if:

  • Parallel psychological treatment
  • Non-stable dosage of psychoactive medication during last 3 months
  • Participants deemed to suffer from suicidal tendencies or another condition requiring specialized treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stockholm University

Stockholm, Sweden

Location

Related Publications (1)

  • Lindner P, Ivanova E, Ly KH, Andersson G, Carlbring P. Guided and unguided CBT for social anxiety disorder and/or panic disorder via the Internet and a smartphone application: study protocol for a randomised controlled trial. Trials. 2013 Dec 18;14:437. doi: 10.1186/1745-6215-14-437.

    PMID: 24351088DERIVED

MeSH Terms

Conditions

Panic DisorderPhobic Disorders

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

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
Professor

Study Record Dates

First Submitted

October 10, 2013

First Posted

October 16, 2013

Study Start

September 1, 2013

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

July 28, 2021

Record last verified: 2021-07

Locations

SE(1)