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An Online Intervention Targeting Depression and Low Reward Sensitivity

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Philipps University

Status

Completed

Conditions

Depression Mild
Depression Moderate

Treatments

Behavioral: Mindulness and Gratitude
Behavioral: Behavioral Activation
Behavioral: Combination of Behavioral Activation and Mindfulness and Gratitude

Study type

Interventional

Funder types

Other

Identifiers

NCT05402150
ReSet your Mind

Details and patient eligibility

About

This study aims to evaluate and compare the effectiveness of different online interventions targeting reward sensitivity and depressive symptoms. We hypothesize that behavioral activation, a mindfulness and gratitude intervention, as well as a combination of both, will significantly reduce depressive symptoms and increase reward sensitivity, compared to the waitlist group. In addition, we assume that behavioral activation will have an increased effect on reward sensitivity compared to the mindfulness and gratitude intervention.

The investigators will further investigate factors influencing treatment success in another paper based on data of this study (see secondary and other pre-specified outcome measures).

Full description

Depression is characterized by low reward sensitivity, which is a potential maintaining factor of depressive symptoms. This is why treatment for depression should include evidence-based interventions that target reward insensitivity. Up until now, there is a lack of research that studies reward sensitivity as main outcome measure or focus of interventions, especially in the online format. However, it is crucial to identify psychological interventions that are most effective in treating low reward sensitivity. Previous studies showed that behavioral activation can be a powerful intervention to increase the availability of rewards in everyday life. In addition, mindfulness-based interventions offer effective interventions with regards to low reward sensitivity since mindfulness refocusses attention on the present moment.

This study aims to evaluate the effectiveness of different online interventions compared to a waitlist control condition in a randomized controlled trial. The sample will include participants with mild to moderate depressive symptoms, who have been preselected for their low trait reward responsiveness. Inclusion and exclusion criteria will be confirmed via a preliminary online survey and a telephone screening, which will be administered by a trained psychologist. Suicidal participants or participants who suffer from severe depression will be excluded. Those will be informed about possibilities to get intensive professional help. Further exclusion criteria will be an ongoing psychotherapy, an antidepressant medication which has been taken for a shorter time period than four weeks, persons with a lifetime diagnosis of bipolar disorder (I and II), psychotic disorders or a substance use disorder.

Participants will be randomly assigned into four groups. The randomization will be stratified according to their depression score (mild or moderate). The investigators aim to include 50 participants per group (N = 200 in total). The first group ("Behavioral Activation") will be instructed to include daily positive activities and fill out a mood protocol, which covers the time period shortly before, during and after the activity. The second group ("Mindfulness and Gratitude") will fill out a mindfulness diary and reflect upon daily pleasant situation via revisiting the impressions of their five senses during this situation. In addition, participants will specify how long they have dealt with the situation and will name something they are grateful for. The third group will do a combination of the two interventions. The fourth group will be the waitlist control condition and receive the intervention material of the third group after two weeks.

Participants will receive a pre-intervention online survey with questionnaires as a baseline measurement. This survey includes a psychoeducation video and an instruction video explaining the intervention rationale and the daily excercises. Participants will receive working sheets to protocol their daily exercises over a course of two weeks. In addition, participants are encouraged to report their results and possible problems with the implementation of the excercises in a short online survey. In addition, every day a different case study will be presented which deals with obstacles and shows strategies to solve problems. Furthermore, participants are able to contact the principal contact person of the study (Laura Potsch) via telephone to help with problems. After two weeks of daily interventions, participants will receive a post-questionnaire to measure treatment effects and will receive a follow up questionnaire after 4 months.

Enrollment

224 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age 18 or above
  • Fluent in German
  • Informed consent
  • Depressive symptoms (PHQ-9 > 5)

Exclusion criteria

  • suicidality, severe depression
  • current or lifetime: substance use disorder, psychotic disorders, bipolar I or II
  • current psychotherapy
  • if antidepressant medication: has not been stable over the last 4 weeks

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

224 participants in 4 patient groups

Behavioral Activation
Experimental group
Description:
14 days of daily excercises
Treatment:
Behavioral: Behavioral Activation
Mindfulness and Gratitude
Experimental group
Description:
14 days of daily excercises
Treatment:
Behavioral: Mindulness and Gratitude
Combination: Behavioral Activation and Mindfulness and Gratitude
Experimental group
Description:
14 days of daily excercises
Treatment:
Behavioral: Combination of Behavioral Activation and Mindfulness and Gratitude
Waitlist control group
No Intervention group
Description:
Will receive the intervention (combination) after two weeks of intervention time of the other groups.

Trial contacts and locations

1

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Central trial contact

Laura Potsch, M.Sc.; Winfried Rief, Prof. Dr.

Data sourced from clinicaltrials.gov

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