Different Levels of Guidance in iCBT for Depression (RCT)

NCT04551794 | Completed

• 1 other identifier: Selfapy
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

The study examines the effectiveness of a internet-based self-help-program called Selfapy for individuals who are experiencing mental stress. The main objective of the study is to investigate the extent to which Selfapy leads to a significant reduction in depressive symptoms. As this study is the first to evaluate the program Selfapy, also quality of life and acceptance of the program are evaluated. The study is conducted as a randomized-controlled trial with parallel assignment into three conditions. The groups were organized into one wait-list control group and two groups receiving access to Selfapy with different levels of guidance.

Conditions

Depressive Symptoms; Quality of Life; Self Esteem

Keywords

Depressive symptoms, iCBT, guidance, peer-support, RCT

Outcome Measures

Primary Outcomes (2)

• Change in depression measured with Patient Health Questionnaire 9 - Depression module (PHQ-9)

  The PHQ-9 (Kroenke et al. 2001) is made up of 9 items which could be self-rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). Major depression and other depression diagnoses according to DSM-IV can be determined according to the overall score. Sum scores of 0-4 indicate none or minimal depressive symptoms, 5-9 mild depressive symptoms, 10-14 moderate depressive symptoms, and 15-27 severe depressive symptoms. Its internal consistency ranges from 0.86-0.89 (Smarr and Keefer 2011).

  Assesses symptoms over the last two weeks; provided at baseline and post (after 3 months); change from baseline to post is being measured

• Change in depression measured with Beck Depression Inventory (BDI-II)

  The BDI-II (Beck et al., 1996) is a 21-item self-report inventory measuring the severity of depression in adolescents and adults. Each item is rated on a four-point Likert scale ranging from 0 (symptom not present) to 3 (symptom very intense). The BDI assesses psychological and physical symptoms over the last two weeks in order to quantify levels of depression. An overall score of 0-13 indicates minimal depression, a score of 14-19 indicates mild depression, a score of 20-28 moderate depression and total scores of 29-63 suggest severe depression. The internal consistency of the BDI-II ranges from 0.79-0.90 (Smarr and Keefer 2011).

  Assesses symptoms over the last two weeks; provided at baseline and post (after 3 months); change from baseline to post is being measured

Secondary Outcomes (2)

• Change in quality of life measured with World Health Organization Quality Of Life - abbreviated version (WHOQOL-BREF)

  Assesses symptoms over the last two weeks; provided at baseline and post (after 3 months); change from baseline to post is being measured

• Questionnaire to measure patient satisfaction (Fragebogen zur Patientenzufriedenheit, ZUF-8)

  Assesses patient satisfaction with the program at the time of assessment; provided only at post (3 months after baseline)

Study Arms (3)

Online self-help program with additional peer support

EXPERIMENTAL

The intervention group receives the login data for the online program directly following the baseline assessment. The program consists of 9 modules with many interactional exercises. Themes that are addressed in the online-program are for example self-esteem, coping with relapse, establishing a structure for daily life and attention and breathing exercises as well as depression-specific topics such as negative thoughts management and arranging and maintaining social contacts. In addition, participants were able to participate in exchange with peers via an internal closed forum.

Behavioral: Selfapy with additional peer support

No intervention: waitlist-control group

NO INTERVENTION

The participants of the wait-list control condition do not receive any new intervention during the intervention period of 9 weeks, but may continue any treatment that has already been started before, including medication. Participants in the wait-list control condition receive full access to the program after completion of the post-assessment.

Online self-help program with therapeutic guidance

EXPERIMENTAL

The intervention group receives the login data for the online program directly following the baseline assessment. The program consists of 9 modules with many interactional exercises. Themes that are addressed in the online-program are for example self-esteem, coping with relapse, establishing a structure for daily life and attention and breathing exercises as well as depression-specific topics such as negative thoughts management and arranging and maintaining social contacts. In addition, participants were able to talk about personal experiences and difficulties concerning the program on a weekly basis with a therapeutic guide on the phone.

Behavioral: Selfapy with therapeutic guidance

Interventions

Selfapy with therapeutic guidance BEHAVIORAL

The program consists of 9 modules with many interactional exercises. Themes that are addressed in the online-program are for example self-esteem, coping with relapse, establishing a structure for daily life and attention and breathing exercises as well as depression-specific topics such as negative thoughts management and arranging and maintaining social contacts. In addition, participants were able to talk about personal experiences with a therapeutic guide.

Online self-help program with therapeutic guidance

Selfapy with additional peer support BEHAVIORAL

The program consists of 9 modules with many interactional exercises. Themes that are addressed in the online-program are for example self-esteem, coping with relapse, establishing a structure for daily life and attention and breathing exercises as well as depression-specific topics such as negative thoughts management and arranging and maintaining social contacts. In addition, participants were able to participate in exchange with peers via an internal closed forum.

Online self-help program with additional peer support

Eligibility Criteria

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

You may qualify if:

• Subjective psychological distress caused by depressive symptoms, wish for treatment, access to Internet, sufficient knowledge of the German language.

You may not qualify if:

• Acute suicidal tendencies, lifetime diagnoses of schizophrenia or bipolar disorder, presence of neurological or dementia disease.

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Steffen Moritz, Prof.

  University Medical Center Hamburg-Eppendorf, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking was not necessary as the participants were automatically randomized within the baseline assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a randomized controlled study with three conditions: Condition 1: Online intervention with therapeutic guidance (telephone contacts). Condition 2: Online intervention with additional peer support (online forum). Condition 3: Wait-list control group (access to the online intervention after completion of the post-assessment). Two assessments-points, the intervention period (pre-post) is three months. At both assessments psychopathological data are obtained via the Internet survey Enterprise Feedback Suite survey by QuestBack Unipark®.

Study Record Dates

• First Submitted: August 29, 2020
• First Posted: September 16, 2020
• Study Start: August 15, 2016
• Primary Completion: December 9, 2016
• Study Completion: December 9, 2016
• Last Updated: September 16, 2020

Record last verified: 2020-09

Locations

DE (1)