Internet Delivered Intervention Program for the Prevention and Treatment of Depression

NCT02148354 | Completed DMC

• 1 other identifier: 4
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Internet-based Treatment for Depression

Keywords

Depression; Self-applied treatment; Internet; Support by the therapist; Cognitive-Behavioural Treatment; Positive Psychology; Behavioral Activation

Outcome Measures

Primary Outcomes (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.

  Up to 12 months

Secondary Outcomes (3)

• Change from Positive and Negative Affect Scale (PANAS) at 3, 6 and 12 months follow-ups

  Up to 12 months

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

  Up to 12 months

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

  Up to 12 months

Other Outcomes (2)

• Change from Multicultural Quality of Life Index (MQLI) at 3, 6 and 12 months follow-ups

  Up to 12 months

• Change from Perceived Stress Scale (PSS) at 3, 6 and 12 months follow-ups

  Up to 12 months

Study Arms (3)

Group with support by the therapist.

EXPERIMENTAL

Intervention group that do the Smiling is Fun program and receives support by the therapist (a brief weekly two-minute call without clinical content).

Behavioral: Smiling is Fun

Group without support by the therapist

EXPERIMENTAL

Intervention group that do the Smiling is Fun program and does not receive support by the therapist.

Behavioral: Smiling is Fun

Waiting list control group

OTHER

Control 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).

Behavioral: Smiling is Fun

Interventions

Smiling is Fun BEHAVIORAL

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.

Also known as: Coping withs stress, Emotion Regulation Program

Group with support by the therapist.; Group without support by the therapist; Waiting list control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universitat Jaume I: lead

Study Sites (1)

University Jaume I

Castellon, Castellón, 12006, Spain

Location

Related Publications (5)

• 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.

  PMID: 22954841 BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 30555384 DERIVED

Related Links

• Laboratory of Psychology and Technology of the University Juame I
• American Psychological Association
• National Institute for Health and Clinical Excellence

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Cristina Botella, Professor

  University Jaume I, Castellón, Spain

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2014
• First Posted: May 28, 2014
• Study Start: March 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 18, 2017

Record last verified: 2017-05

Locations

ES (1)