NCT04753801

Brief Summary

This study aims to determine the relevant 'ingredients' to make the best possible self (BPS) intervention most efficacious and test whether the BPS's efficacy can be enhanced by including mindfulness aspects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 15, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2021

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

2 months

First QC Date

February 9, 2021

Last Update Submit

August 6, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in emotions (PANAS)

    Change scores are calculated for positive and negative sum scores (post- minus pre-scores; pre-scores will be used as a covariate).

    Change from pre (baseline) to post scores (approx. 30 minutes later)

Secondary Outcomes (2)

  • Change in state optimism ratings

    Change from pre (baseline) to post scores (approx. 30 minutes later)

  • Change in emotional responses to imagery of neutral, pleasant and aversive narrative scripts

    Change from pre (baseline) to post scores (approx. 30 minutes later)]

Study Arms (5)

Best Possible Self (writing only)

EXPERIMENTAL

Participants are asked to think and write about their best possible future self (15 min).

Behavioral: Thinking, writing and imagination

Best Possible Self (writing+imagining)

EXPERIMENTAL

Participants are asked to think and write about their best possible future self (15 min) and, then to imagine their positive future (5 min).

Behavioral: Thinking, writing and imagination

Best Possible Self (writing+mindfulness)

EXPERIMENTAL

Participants are asked to think and write about their best possible future self (15 min) and subsequently engage in a brief mindfulness sequence (5 min).

Behavioral: Thinking, writing and imagination

Best Possible Self (writing+recall)

EXPERIMENTAL

Participants are asked to think and write about their best possible future self (15 min) and subsequently engage in a brief recall imagination task about the past two days (5 min).

Behavioral: Thinking, writing and imagination

Writing about the past

ACTIVE COMPARATOR

Participants are asked to think and write about activities of the past two days (15 min).

Behavioral: Thinking, writing and imagination

Interventions

All participants are asked to take some time to think and write about the respective intervention group's content. In some groups (after the writing exercise (approx. 15min)), participants are also asked to imagine that content or engage in a mindfulness activity or recall task for about 5 minutes.

Best Possible Self (writing only)Best Possible Self (writing+imagining)Best Possible Self (writing+mindfulness)Best Possible Self (writing+recall)Writing about the past

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • fluent in the German language
  • access to a computer/tablet/smartphone with audio output/headphones

You may not qualify if:

  • not willing to take part in an online-intervention (duration: 60 minutes)
  • no access to a computer/tablet/smartphone with audio output/headphones

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg

Marburg, 35032, Germany

Location

Related Publications (1)

  • Millstein RA, Chung WJ, Hoeppner BB, Boehm JK, Legler SR, Mastromauro CA, Huffman JC. Development of the State Optimism Measure. Gen Hosp Psychiatry. 2019 May-Jun;58:83-93. doi: 10.1016/j.genhosppsych.2019.04.002. Epub 2019 Apr 4.

    PMID: 31026732BACKGROUND

Study Officials

  • Winfried Rief, Prof.

    Philipps University Marburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2021

First Posted

February 15, 2021

Study Start

February 1, 2021

Primary Completion

March 27, 2021

Study Completion

March 31, 2021

Last Updated

August 7, 2024

Record last verified: 2024-08

Locations