ACT-smart: Smartphone-supplemented iCBT for Social Phobia and/or Panic Disorder

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Per Carlbring, Stockholm University
ClinicalTrials.gov Identifier:
NCT01963806
First received: October 10, 2013
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Panic Disorder
Phobic Disorders
Behavioral: Smartphone-supplemented iCBT
Behavioral: Therapist support
Other: Active waiting list

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Guided and Unguided CBT for Social Anxiety Disorder and/or Panic Disorder Via the Internet and a Smartphone Application

Resource links provided by NLM:


Further study details as provided by Stockholm University:

Primary Outcome Measures:
  • The Generalised Anxiety Disorder 7-item (GAD-7) [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Self-rated Liebowitz Social Anxiety Scale (LSAS-SR) [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • Self-rated Panic Disorder Severity Scale (PDSS-SR) [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • 9-item Patient Health Questionnaire (PHQ-9) [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • Quality of Life Inventory (QOLI) [ Time Frame: 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: September 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Smartphone-supplemented iCBT with therapist support
n = 50
Behavioral: Smartphone-supplemented iCBT

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.

Behavioral: Therapist support
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.
Experimental: Smartphone-supplemented iCBT without therapist support
n = 50
Behavioral: Smartphone-supplemented iCBT

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 Comparator: Active waiting list control group with delayed treatment
n = 50
Behavioral: Smartphone-supplemented iCBT

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.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01963806

Locations
Sweden
Stockholm University
Stockholm, Sweden
Sponsors and Collaborators
Stockholm University
  More Information

Additional Information:
No publications provided by Stockholm University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Per Carlbring, Professor, Stockholm University
ClinicalTrials.gov Identifier: NCT01963806     History of Changes
Other Study ID Numbers: ACT-smart
Study First Received: October 10, 2013
Last Updated: November 27, 2013
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Panic Disorder
Phobic Disorders
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014