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Internet-based Treatment for DepressionNCT02148354

Internet Delivered Intervention Program for the Prevention and Treatment of Depression

A study testing Smiling is Fun in people with Internet-based Treatment for Depression, run by Universitat Jaume I at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the differential effectiveness of a self applied treatment delivered via Internet for the prevention and treatment of depression, with or without support by the therapist, compared to a waiting list control group. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Internet-based Treatment for Depression
What is being tested?
Smiling is Fun
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteSpain
Study dates
Mar 2012to Apr 2014
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-65 years old.
  • Be willing to participate in the study.
  • Be able to use a computer and having an Internet connection at home.
  • Be able to understand and read Spanish.
  • Minimal, mild, or moderate depression (score no more than 28 in the BDI-II).
  • Experience, at least, one stressful event in their lives that provokes them an interference.

Who cannot join

  • Be receiving psychological treatment.
  • Have received another psychological treatment in the past year.
  • A severe mental disorder on Axis I: abuse or dependence of alcohol or other substances, psychotic disorder or dementia.
  • Presence of suicidal ideation or plan (Evaluated by MINI and item 9 of the BDI-II).

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • University Jaume I

    Castellon, Castellón, 12006

Other trials in Spain

About this study

Official title: Differential Efficacy of an Internet Delivered Intervention Program for the Prevention and Treatment of Mild to Moderate Depression With or Without Support by the Therapist

The purpose of this study is to determine the differential effectiveness of a self applied treatment delivered via Internet for the prevention and treatment of depression, with or without support by the therapist, compared to a waiting list control group. The principal hypothesis is that the two intervention groups will improve significantly compared to the waiting list control group, and without significant differences between them. The investigators believe that the support of ICTs may be doing a similar function as the weekly support call (to offer feedback, to reinforce, to motivate the participants, etc.). Furthermore the investigators hypothesize that the intervention program will be a useful tool for a secondary and tertiary prevention of depression.

Read the detailed description

It is know that 25% of all human beings will suffer from depression at any moment over their lives and it will become one of the three leading causes of disability in 2030 (Mathers and Loncar, 2006). A very important challenge today consists on addressing the issue of depression from a preventive perspective (Mihalopoulos and Vos, 2013) operating in each of its three levels: primary prevention, to reduce its incidence, secondary prevention, for people who have some risk factor or those who show subclinical symptoms, and tertiary prevention, to minimize the limitations caused by an already established disorder (Commission on Chronic Illness, 1957; Vazquez and Torres, 2007). As Cuijpers, Beekman et al. (2012) point out in a recent paper, it is important to develop better strategies and tools to identify individuals at risk and the design of prevention programs. The investigators have evidence based psychological treatments for depression (Nathan and Gorman, 2007) and, although less there are also interventions focusing on its prevention (Cuijpers et al., 2008, Horowitz y Garber, 2006; Muñoz et al., 2010). However, they have an important limitation: the provision of mental health services is generally less than adequate in terms of accessibility and quality (Hinrichsen, 2010, Institute of Medicine, 2008; Kazdin and Blase, 2011). The Information and Communication Technologies (ICTs), especially the use of the Internet to support the implementation of the interventions (treatment or prevention), have proven to be a powerful means for its effective deployment in general mental healthcare provision. Although data using Internet-based interventions are consistent and promising, there are still important problems to solve: not all patients continue and complete these programs. The meta-analysis of studies on Internet-based treatments for depression report a dropout rate of 32% (range 0-75%) (Kaltenthaler, Parry, Beverley and Ferriter, 2008; Melville, Casey and Kavanagh, 2010). This problem could have various causes and one of which may be the fact of providing or not human support (Andersson et al., 2009). Recently, there has been increased research to determine the importance of human support in such interventions (Richards y Richardsson, 2012; Hilvert-Bruce, Rossouw, Wong, Sunderland and Andrews, 2012). The studies of meta-analysis find that the Internet-based treatments, in which support is given throughout the implementation of the program, produce greater effect sizes and less dropout rates than Internet-based programs without any human support (Andersson and Cuijpers, 2009; Richards and Richardson, 2012). It is important to note that the majority of studies mean support when it is administered by a person (therapist, consultant or researcher) and not by the ICTs (automated reminders, e-mails or mobile SMS) (Richards and Richardson, 2012). Now, there has also been recent evidence of the effectiveness of the self-applied treatments without any contact or support from a therapist, consultant or researcher (Cuijpers, Donker et al, 2011). Nevertheless, there are still few randomized controlled trials that specifically examine this issue (Berger et al., 2011, Clarke et al, 2005; Farrer, Christensen, Griffiths and Mackinnon, 2011). This is the principal objective of the present work, given the importance that this may have for the future developments in this field. The investigators addressed: It is necessary a weekly support call from a therapist during the course of an Internet- based intervention program, or is it enough just the support of the ICTs?. Because of this, the investigators have developed an Internet-based program (Smiling is Fun) for the prevention and treatment of depression (mild to moderate), and have carried out a randomized controlled trial with three experimental conditions: a) Intervention group with human support (two minutes weekly support call without clinical content); b) Intervention group without human support; c) Waiting list control condition. The two intervention groups received automated support from the ICTs: two weekly automated mobile phone messages, reminding of the importance of doing the tasks proposed by the program and, an automated e-mail encouraging them to continue with the modules in case they have not accesses the program for a week. The principal hypothesis is that the two intervention groups will improve significantly compared to the waiting list control group, and without significant differences among themselves. The investigators believe that the support of ICTs may be doing a similar function as the weekly support call (to offer feedback, to reinforce, to motivate the participants, etc.). Furthermore the investigators hypothesize that the intervention program will be a useful tool for a secondary and tertiary prevention of depression.

Being tested
Smiling is Fun
Keywords
Depression, Self-applied treatment, Internet, Support by the therapist, Cognitive-Behavioural Treatment, Positive Psychology, Behavioral Activation
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Smiling is FunBehavioural

    Also called Coping withs stress, Emotion Regulation Program

    Smiling is Fun is an internet-delivered self-help program for emotional disorders, which will allow the individual to learn and practice adaptive ways to cope with depression and daily problems. The program includes eight modules: Motivation for change, Understanding emotional problems; Learning to move on; Learning to enjoy; Learning to live; Living and learning and From now on, what else…?. Furthermore the program uses three transversal tools: 1) Activity report for self-monitoring, whose aim is to provide feedback to the user and help him see that his mood is related to the activities performed, 2) The calendar, and 3) "How am I?" offers a set of graphs and feedbacks to chart the user's progress.

Study groups in NCT02148354
Study groupRoleWhat they receive
Group with support by the therapist.ExperimentalIntervention group that do the Smiling is Fun program and receives support by the therapist (a brief weekly two-minute call without clinical content).
Receives: Behavioral: Smiling is Fun
Group without support by the therapistExperimentalIntervention group that do the Smiling is Fun program and does not receive support by the therapist.
Receives: Behavioral: Smiling is Fun
Waiting list control groupOtherControl group that could access the Smiling is Fun program after waiting for 12 weeks. After that time, those participants still interested were randomly assigned to one of two intervention conditions (with or without support by the therapist).
Receives: Behavioral: Smiling is Fun

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Beck Depression Inventory II (BDI-II) at 3, 6 and 12 months follow-ups

    This is one of the most widely questionnaires used to evaluate severity of depression in pharmacological and psychotherapy trials. The instrument has good internal consistency (Cronbach's alpha of 0.76 to 0.95) and test-retest reliability of around 0.8. The Spanish version of this instrument has also shown a high internal consistency (Cronbach's alpha of 0.87) for both the general and the clinical population (Cronbach's alpha of 0.89). Summed to obtain the total score, which can be a maximum of 63 points. According to the BDI-II manual scores of 0 to 13 denote minimal depression, scores of 14 to 19 denote mild depression, scores of 20 to 28 denote moderate depression and over 28 indicates severe depression.

    Measured: Up to 12 months

Secondary outcomes (3)
  1. Change from Positive and Negative Affect Scale (PANAS) at 3, 6 and 12 months follow-ups

    PANAS consists of 20 items that evaluate two independent dimensions: positive affect (PA) and negative affect (NA). The range for each scale (10 items on each) is 10 to 50. The Spanish version has demonstrated high internal consistency (0.89 to 0.91 for PA and NA in women and 0.87 for AP and 0.89 for AN in men) in college students. This is consistent with the findings in the literature.

    Measured: Up to 12 months

  2. Change from Overall Anxiety Severity and Impairment Scale (OASIS) at 3, 6 and 12 months follow-ups

    OASIS consists of 5 items that measure the frequency and severity of anxiety, as well as the level of avoidance, work/ school/home interference, and social interference associated to anxiety. A psychometric analysis of the OASIS scale found good internal consistency (Cronbach's alpha = 0.80), test-retest reliability (k = 5.82) and convergent validity for this scale.

    Measured: Up to 12 months

  3. Change from Overall Depression Severity and Impairment Scale (ODSIS) at 3, 6 and 12 months follow-ups

    ODSIS is a self-report measure which consists of 5 items, evaluating experiences related to depression. ODSIS measures the frequency and severity of depression, as well as the level of avoidance, work/school/home interference, and social interference associated to depression. So far, no other studies examining the psychometric properties of this scale have been published. It is recommended to use and to interpret it in the same way that OASIS.

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2014 (estimated)
  2. Study startMar 2012
  3. Primary completionApr 2014
  4. Study completionApr 2014

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02148354
Sponsor's protocol ID
4
Status last verified
May 2017
First submitted
13 Mar 2014
Last updated
18 May 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Botella C, Mira A, Garcia-Palacios A, Quero S, Navarro MV, Riera Lopez Del Amo A, Molinari G, Castilla D, Moragrega I, Soler C, Alcaniz M, Banos RM. Smiling is fun: a Coping with Stress and Emotion Regulation Program. Stud Health Technol Inform. 2012;181:123-7.

    PubMed 22954841
  • Mira A, Botella C, García-Palacios A., Riera A, Quero S, Alcañiz M, Baños RM. An Internet-based Program to Cope with Regulating Stress and Emotion: An Example of Positive Technology. Journal of Cybertherapy & Rehabilitation, 2(1): 22-23, 2012.

  • Mira A, Botella C, García-Palacios A, Bretón-López J, Moragrega I, Riera-López del Amo A, Quero S, Pérez-Ara, MA, Baños RM. Coping with Stress: A Program for the Prevention of Depression. Information and Communication Technologies applied to Mental Health. Proceedings of the 1st Workshop on ICT applied to Mental Health, 48-52, 2012

  • Alcañiz, M, Zaragoza I, Rey B, Botella C, Moragrega I, Baños RM. Personal Health Systems: The OPTIMI Project. Journal of Cybertherapy & Rehabilitation 1: 20-23, 2011.

  • Mira A, Breton-Lopez J, Enrique A, Castilla D, Garcia-Palacios A, Banos R, Botella C. Exploring the Incorporation of a Positive Psychology Component in a Cognitive Behavioral Internet-Based Program for Depressive Symptoms. Results Throughout the Intervention Process. Front Psychol. 2018 Nov 29;9:2360. doi: 10.3389/fpsyg.2018.02360. eCollection 2018.

    PubMed 30555384

Questions about this trial

What is this clinical trial studying?

A study testing Smiling is Fun in people with Internet-based Treatment for Depression, run by Universitat Jaume I at 1 site in Spain.

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 6 inclusion and 4 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 18 May 2017. 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 Spain. 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?

Change from Beck Depression Inventory II (BDI-II) at 3, 6 and 12 months follow-ups (time frame: Up to 12 months). 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 NCT02148354, which also lists 5 linked publications.

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 18 May 2017; AzTrials last refreshed its copy on 6 Nov 2026.

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