Panic DisorderNCT01963806
ACT-smart: Smartphone-supplemented iCBT for Social Phobia and/or Panic Disorder
A study testing Smartphone-supplemented iCBT, Therapist support and Active waiting list in people with Panic Disorder and Phobic Disorders, run by Stockholm University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Panic Disorder, Phobic Disorders
- What is being tested?
- Smartphone-supplemented iCBT, Therapist support and Active waiting list
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2013to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Guided and Unguided CBT for Social Anxiety Disorder and/or Panic Disorder Via the Internet and a Smartphone Application
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.
- Conditions
- Panic Disorder, Phobic Disorders
- Being tested
- Smartphone-supplemented iCBT, Therapist support, Active waiting list
- Medical subject headings
- Panic Disorder, Phobic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone-supplemented iCBTBehavioural
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.
Therapist supportBehavioural
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.
Active waiting listOther
Completes measurements at day 24 and 48 and at the end of the initial treatment period, otherwise no activity until crossover.
| Study group | Role | What they receive |
|---|---|---|
| Smartphone-supplemented iCBT with therapist support | Experimental | n = 50 Receives: Behavioral: Smartphone-supplemented iCBT; Behavioral: Therapist support |
| Smartphone-supplemented iCBT without therapist support | Experimental | n = 50 Receives: Behavioral: Smartphone-supplemented iCBT |
| Active waiting list control group with delayed treatment | Active comparator | n = 50 Receives: Behavioral: Smartphone-supplemented iCBT; Other: Active waiting list |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Panic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stockholm University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per Carlbring, Stockholm University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963806
- Sponsor's protocol ID
- ACT-smart
- Status last verified
- Jul 2021
- First submitted
- 10 Oct 2013
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24351088
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided and Unguided CBT for Social Anxiety Disorder and/or Panic Disorder Via the Internet and a Smartphone Application
- ClinicalTrials.gov ID
- NCT01963806
- Acronym / sponsor ID
- ACT-smart
- Conditions
- Panic Disorder, Phobic Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Stockholm UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 16 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Smartphone-supplemented iCBT with therapist support | Experimental | Behavioral: Smartphone-supplemented iCBT, Behavioral: Therapist supportn = 50 |
| Smartphone-supplemented iCBT without therapist support | Experimental | Behavioral: Smartphone-supplemented iCBTn = 50 |
| Active waiting list control group with delayed treatment | Active comparator | Behavioral: Smartphone-supplemented iCBT, Other: Active waiting listn = 50 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone-supplemented iCBTThe 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. | Behavioural | Active waiting list control group with delayed treatment, Smartphone-supplemented iCBT with therapist support, Smartphone-supplemented iCBT without therapist support |
| Therapist supportThe 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. | Behavioural | Smartphone-supplemented iCBT with therapist support |
| Active waiting listCompletes measurements at day 24 and 48 and at the end of the initial treatment period, otherwise no activity until crossover. | Other | Active waiting list control group with delayed treatment |
Primary outcome
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.
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.
4 secondary outcomes
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Derived from this study: PubMed 24351088Lindner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone-supplemented iCBT, Therapist support and Active waiting list in people with Panic Disorder and Phobic Disorders, run by Stockholm University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01963806, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.